Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02752958
• Collaborator: (none)
• Enrollment: 75
• Locations: 2
• Arm: 1
• Actual Duration (Months): 8.4
• Patients Per Site: 37.5
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

This multicentre, non-comparative design study will monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers. Changes in oral health related quality of life will be monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

Condition or Disease	Intervention/Treatment	Phase
Dentin Sensitivity	Drug: stannous fluoride	N/A

Detailed Description

This will be multicenter, non-comparative design to monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers, using the DHEQ. Changes in DH will be monitored clinically over the 24 week treatment period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Study to Investigate the Impact on Oral Health Related Quality of Life of Managing Dentine Hypersensitivity With a Daily Use Anti-Sensitivity Toothpaste
• Actual Study Start Date: May 23, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Feb 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stannous fluoride This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.	Drug: stannous fluoride; 0.454% w/w (weight per weight) stannous fluoride

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4 [At Baseline and Week 4]

   All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

2. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8 [At Baseline and Week 8]

   All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

3. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12 [At Baseline and Week 12]

   All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

4. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16 [At Baseline and Week 16]

   All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

5. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20 [At Baseline and Week 20]

   All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

6. Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24 [At Baseline and Week 24]

   All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).

7. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4 [At Baseline and Week 4]

   All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

8. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8 [At Baseline and Week 8]

   All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

9. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12 [At Baseline and Week 12]

   All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

10. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16 [At Baseline and Week 16]

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

11. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20 [At Baseline and Week 20]

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

12. Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24 [At Baseline and Week 24]

    All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.

13. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4 [At Baseline and Week 4]

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

14. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8 [At Baseline and Week 8]

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

15. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12 [At Baseline and Week 12]

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

16. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16 [At Baseline and Week 16]

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

17. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20 [At Baseline and Week 20]

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

18. Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24 [At Baseline and Week 24]

    All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.

19. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4 [At Baseline and Week 4]

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

20. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8 [At Baseline and Week 8]

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

21. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12 [At Baseline and Week 12]

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

22. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16 [At Baseline and Week 16]

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

23. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20 [At Baseline and Week 20]

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

24. Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24 [At Baseline and Week 24]

    All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.

25. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4 [At Baseline and Week 4]

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

26. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8 [At Baseline and Week 8]

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

27. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12 [At Baseline and Week 12]

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

28. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16 [At Baseline and Week 16]

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

29. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20 [At Baseline and Week 20]

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

30. Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24 [At Baseline and Week 24]

    All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.

31. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4 [At Baseline and Week 4]

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

32. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8 [At Baseline and Week 8]

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

33. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12 [At Baseline and Week 12]

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

34. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16 [At Baseline and Week 16]

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3 disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me fee damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

35. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20 [At Baseline and Week 20]

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

36. Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24 [At Baseline and Week 24]

    All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.

37. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4 [At Baseline and Week 4]

    All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

38. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8 [At Baseline and Week 8]

    All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

39. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12 [At Baseline and Week 12]

    All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

40. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16 [At Baseline and Week 16]

    All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

41. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20 [At Baseline and Week 20]

    All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

42. Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24 [At Baseline and Week 24]

    All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?

43. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4 [At Baseline and Week 4]

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

44. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8 [At Baseline and Week 8]

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

45. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12 [At Baseline and Week 12]

    : All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

46. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16 [At Baseline and Week 16]

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

47. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20 [At Baseline and Week 20]

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

48. Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24 [At Baseline and Week 24]

    All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?

49. Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4 [At Baseline and Week 4]

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

50. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8 [At Baseline and Week 8]

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

51. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12 [At Baseline and Week 12]

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

52. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16 [At Baseline and Week 16]

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

53. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20 [At Baseline and Week 20]

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

54. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24 [At Baseline and Week 24]

    All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

55. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4 [At Baseline and Week 4]

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

56. Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8 [At Baseline and Week 8]

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

57. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12 [At Baseline and Week 12]

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and impact they had on participant's everyday life.

58. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16 [At Baseline and Week 16]

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

59. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20 [At Baseline and Week 20]

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

60. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24 [At Baseline and Week 24]

    All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

61. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4 [At Baseline and Week 4]

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

62. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8 [At Baseline and Week 8]

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

63. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12 [At Baseline and Week 12]

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

64. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16 [At Baseline and Week 16]

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

65. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20 [At Baseline and Week 20]

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

66. Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24 [At Baseline and Week 24]

    All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy ofthe informed consent form

• Aged 18-55 years

• Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral examination and absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements

• Understands and is willing, able and likely to comply with all study procedures and restrictions

• At Visit 1 (Screening): Self-reported his of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years, minimum of 20 natural teeth, Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).Tooth with MGI score =0 adjacent to the test area (exposed dentine) only [Lobene, 1986] and a clinical mobility of ≤1 Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)

• At Visit 2 (Baseline): Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria: with signs of sensitivity, measured by a qualifying evaporative air assessment (Schiff Sensitivity Score ≥ 2)

Exclusion Criteria:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study

• Women who are breast-feeding

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.

and previous participation in this study

• Recent history (within the last year) of alcohol or other substance abuse

• An employee of the sponsor or the study site or members of their immediate family

• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes and any condition which, in the opinion of the investigator, causes xerostomia

• Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing or presence of dental implants, desensitizing treatment within 8 weeks of Screening (professional sensitivity, treatments and non-dentifrice sensitivity treatments), gross periodontal disease, treatment of periodontal disease (including surgery)within 12 months of Screening, scaling or root planning within 3 months of Screening and teeth bleaching within 8 weeks of Screening

• Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening, tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine and Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator

• Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)

• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, anti-depressants, mood-altering and anti-inflammatory drugs, currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline and daily dose of a medication which, in the opinion of the investigator, is causing xerostomia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Ellesmere Port	Cheshire	United Kingdom	CH65 4BW
2	GSK Investigational Site	Widnes	Cheshire	United Kingdom	WA8 6PG

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Sep 12, 2016
• Statistical Analysis Plan - Nov 10, 2016

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02752958
• Other Study ID Numbers: 204930
• First Posted: Apr 27, 2016
• Last Update Posted: Aug 27, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Dentin Sensitivity; Hypersensitivity; Fluorides; Tin Fluorides

Study Results

Participant Flow

Recruitment Details	This study had 2 centers in United Kingdom (UK) but, all the participants were recruited from the 1 center only.
Pre-assignment Detail	A total of 163 participants were screened, of which 75 participants were enrolled and randomized in the study. A total of 88 participants were not randomized in study as 53 participants did not meet study criteria, 1 participant had adverse event (AE), 3 were lost to follow up, 6 had protocol violation and 25 due to other reason (not specified).

Arm/Group Title	Overall Study: Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing 0.454% weight by weight (w/w) stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Period Title: Overall Study
STARTED	75
COMPLETED	66
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Stannous Fluoride
Arm/Group Description	Participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening).
Overall Participants	75
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.2 (8.88)
Sex: Female, Male (Count of Participants)
Female	58 77.3%
Male	17 22.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	75 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4
Description	All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	142.41 (36.084)
At Week 4	135.24 (34.745)
Change from Baseline at Week 4	-6.28 (22.852)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 (Baseline ) versus (vs.) Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0944
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.89
	Confidence Interval	(2-Sided) 95%; -1.018 to 12.80
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus Week 4 score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

2. Primary Outcome

Title	Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8
Description	All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	142.41 (36.084)
At Week 8	126.58 (42.131)
Change from Baseline at Week 8	-16.33 (32.512)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 (baseline) vs. Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.99
	Confidence Interval	(2-Sided) 95%; 10.128 to 23.849
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

3. Primary Outcome

Title	Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12
Description	All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	142.41 (36.084)
At Week 12	120.39 (44.694)
Change from Baseline at Week 12	-22.54 (39.724)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 (baseline) vs. Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.70
	Confidence Interval	(2-Sided) 95%; 15.870 to 29.539
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

4. Primary Outcome

Title	Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16
Description	All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	142.41 (36.084)
At Week 16	115.36 (43.977)
Change from Baseline at Week 16	-27.68 (38.654)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 (baseline) vs. Week 16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	27.21
	Confidence Interval	(2-Sided) 95%; 20.245 to 34.165
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

5. Primary Outcome

Title	Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20
Description	All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	142.41 (36.084)
At Week 20	112.32 (49.163)
Change from Baseline at Week 20	-30.58 (42.591)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	31.42
	Confidence Interval	(2-Sided) 95%; 24.464 to 38.385
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24
Description	All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	142.41 (36.084)
At Week 24	111.20 (50.179)
Change from Baseline at Week 24	-31.70 (44.268)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 (baseline) vs. Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	32.55
	Confidence Interval	(2-Sided) 95%; 25.585 to 39.506
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

7. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4
Description	All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	19.55 (5.088)
At Week 4	18.24 (4.707)
Change from Baseline at Week 4	-1.21 (4.021)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs. Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0312
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.108 to 2.262
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

8. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8
Description	All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	19.55 (5.088)
At Week 8	16.86 (5.712)
Change from Baseline at Week 8	-2.75 (4.924)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.80
	Confidence Interval	(2-Sided) 95%; 1.728 to 3.866
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

9. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12
Description	All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	19.55 (5.088)
At Week 12	16.31 (6.147)
Change from Baseline at Week 12	-3.19 (5.619)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs. Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.26
	Confidence Interval	(2-Sided) 95%; 2.192 to 4.322
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

10. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16
Description	All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	19.55 (5.088)
At Week 16	15.55 (5.786)
Change from Baseline at Week 16	-3.98 (5.284)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.93
	Confidence Interval	(2-Sided) 95%; 2.844 to 5.012
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

11. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20
Description	All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	19.55 (5.088)
At Week 20	15.50 (6.422)
Change from Baseline at Week 20	-3.94 (5.865)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs. Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.15
	Confidence Interval	(2-Sided) 95%; 3.063 to 5.232
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

12. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24
Description	All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	19.55 (5.088)
At Week 24	14.91 (6.738)
Change from Baseline at Week 24	-4.53 (5.717)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.74
	Confidence Interval	(2-Sided) 95%; 3.654 to 5.823
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

13. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4
Description	All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	53.12 (13.582)
At Week 4	51.42 (13.596)
Change from Baseline at Week 4	-1.46 (9.711)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4185
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; -1.592 to 3.821
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline

14. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8
Description	All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	53.12 (13.582)
At Week 8	46.43 (16.453)
Change from Baseline at Week 8	-6.80 (12.678)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.08
	Confidence Interval	(2-Sided) 95%; 4.391 to 9.764
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

15. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12
Description	All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	53.12 (13.582)
At Week 12	45.04 (16.985)
Change from Baseline at Week 12	-8.27 (14.998)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.35
	Confidence Interval	(2-Sided) 95%; 5.674 to 11.026
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu

16. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16
Description	All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	53.12 (13.582)
At Week 16	42.59 (16.966)
Change from Baseline at Week 16	-10.45 (15.037)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 16
	Type of Statistical Test	Other
	Comments	Week 0 Vs Week 16
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.43
	Confidence Interval	(2-Sided) 95%; 7.708 to 13.158
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

17. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20
Description	All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	53.12 (13.582)
At Week 20	41.89 (18.607)
Change from Baseline at Week 20	-11.48 (15.304)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.73
	Confidence Interval	(2-Sided) 95%; 9.008 to 14.459
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

18. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24
Description	All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	53.12 (13.582)
At Week 24	41.67 (19.449)
Change from Baseline at Week 24	-11.71 (16.270)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.96
	Confidence Interval	(2-Sided) 95%; 9.235 to 14.686
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

19. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4
Description	All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	Participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening).
Measure Participants	73
At Baseline	17.99 (6.138)
At Week 4	17.30 (6.110)
Change from Baseline at Week 4	-0.57 (4.265)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3415
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95%; -0.604 to 1.738
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

20. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8
Description	All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	17.99 (6.138)
At Week 8	16.32 (6.701)
Change from Baseline at Week 8	-1.67 (5.524)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0029
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.77
	Confidence Interval	(2-Sided) 95%; 0.610 to 2.935
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline

21. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12
Description	All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	17.99 (6.138)
At Week 12	15.60 (6.787)
Change from Baseline at Week 12	-2.64 (6.459)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.42
	Confidence Interval	(2-Sided) 95%; 1.266 to 3.582
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

22. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16
Description	All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	17.99 (6.138)
At Week 16	14.44 (6.528)
Change from Baseline at Week 16	-3.62 (6.144)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.55
	Confidence Interval	(2-Sided) 95%; 2.371 to 4.729
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

23. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20
Description	All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	17.99 (6.138)
At Week 20	13.79 (7.312)
Change from Baseline at Week 20	-4.33 (6.971)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.39
	Confidence Interval	(2-Sided) 95%; 3.210 to 5.568
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

24. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24
Description	All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	17.99 (6.138)
At week 24	13.88 (7.154)
Change from Baseline at Week 24	-4.24 (6.730)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.30
	Confidence Interval	(2-Sided) 95%; 3.119 to 5.477
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

25. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4
Description	All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	35.48 (9.106)
At Week 4	32.64 (8.388)
Change from Baseline at Week 4	-2.40 (6.649)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0145
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.42
	Confidence Interval	(2-Sided) 95%; 0.483 to 4.352
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

26. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8
Description	All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	35.48 (9.106)
At Week 8	31.42 (10.322)
Change from Baseline at Week 8	-4.30 (8.742)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.42
	Confidence Interval	(2-Sided) 95%; 2.498 to 6.339
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

27. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12
Description	All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	35.48 (9.106)
At Week 12	28.79 (11.518)
Change from Baseline at Week 12	-6.86 (11.119)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.85
	Confidence Interval	(2-Sided) 95%; 4.933 to 8.759
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

28. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16
Description	All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessm

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	35.48 (9.106)
At Week 16	28.24 (10.722)
Change from Baseline at Week 16	-7.33 (10.316)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.17
	Confidence Interval	(2-Sided) 95%; 5.219 to 9.115
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

29. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20
Description	All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	35.48 (9.106)
At week 20	27.32 (12.800)
Change from Baseline at Week 20	-8.17 (11.493)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.39
	Confidence Interval	(2-Sided) 95%; 6.438 to 10.335
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

30. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24
Description	All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	35.48 (9.106)
At Week 24	27.03 (12.701)
Change from Baseline at Week 24	-8.45 (12.158)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs. Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.67
	Confidence Interval	(2-Sided) 95%; 6.726 to 10.623
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

31. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4
Description	All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	16.27 (7.256)
At Week 4	15.66 (7.300)
Change from Baseline at Week 4	-0.64 (5.804)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3676
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; -0.738 to 1.989
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

32. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8
Description	All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	16.27 (7.256)
At Week 8	15.55 (7.295)
Change from Baseline at Week 8	-0.81 (6.314)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1907
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; -0.451 to 2.255
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

33. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12
Description	All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	16.27 (7.256)
At Week 12	14.64 (7.404)
Change from Baseline at Week 12	-1.83 (7.305)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs. Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0085
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.81
	Confidence Interval	(2-Sided) 95%; 0.467 to 3.162
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

34. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16
Description	All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3 disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me fee damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	16.27 (7.256)
At Week 16	14.55 (8.079)
Change from Baseline at Week 16	-2.29 (8.105)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0026
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.12
	Confidence Interval	(2-Sided) 95%; 0.744 to 3.489
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

35. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20
Description	All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	16.27 (7.256)
At Week 20	13.82 (8.320)
Change from Baseline at Week 20	-2.65 (8.950)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.74
	Confidence Interval	(2-Sided) 95%; 1.371 to 4.116
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24
Description	All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	16.27 (7.256)
At Week 24	13.71 (8.364)
Change from Baseline at Week 24	-2.76 (8.769)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.85
	Confidence Interval	(2-Sided) 95%; 1.477 to 4.222
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

37. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4
Description	All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	3.38 (0.926)
At Week 4	3.24 (0.889)
Change from Baseline at Week 4	-0.14 (0.654)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2326
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.059 to 0.243
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu

38. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8
Description	All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	3.38 (0.926)
At Week 8	3.32 (0.947)
Change from Baseline at Week 8	-0.04 (0.721)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3934
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.085 to 0.216
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

39. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12
Description	All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	3.38 (0.926)
At Week 12	3.27 (0.850)
Change from Baseline at Week 12	-0.12 (0.697)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0795
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; -0.016 to 0.284
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

40. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16
Description	All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	3.38 (0.92)
At Week 16	3.24 (0.912)
Change from Baseline at Week 16	-0.14 (0.788)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0682
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.011 to 0.294
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

41. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20
Description	All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	3.38 (0.926)
At Week 20	3.29 (0.941)
Change from Baseline at Week 20	-0.11 (0.831)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0844
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; -0.018 to 0.287
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

42. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24
Description	All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	3.38 (0.926)
At Week 24	3.24 (0.946)
Change from Baseline at Week 24	-0.15 (0.755)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0211
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; 0.027 to 0.332
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

43. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4
Description	All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	6.56 (3.539)
At Week 4	5.88 (3.278)
Change from Baseline at Week 4	-0.64 (2.515)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0493
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.002 to 1.194
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

44. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8
Description	All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	6.56 (3.539)
At Week 8	5.12 (3.292)
Change from Baseline at Week 8	-1.43 (2.757)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.42
	Confidence Interval	(2-Sided) 95%; 0.830 to 2.013
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

45. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12
Description	: All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	6.56 (3.539)
At Week 12	4.70 (3.276)
Change from Baseline at Week 12	-1.87 (3.139)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.87
	Confidence Interval	(2-Sided) 95%; 1.278 to 2.457
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

46. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16
Description	All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	6.56 (3.539)
At Week 16	4.42 (3.054)
Change from Baseline at Week 16	-2.12 (3.218)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.03
	Confidence Interval	(2-Sided) 95%; 1.429 to 2.629
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

47. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20
Description	All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	6.56 (3.539)
At Week 20	4.29 (3.436)
Change from Baseline at Week 20	-2.32 (3.613)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.34
	Confidence Interval	(2-Sided) 95%; 1.743 to 2.943
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

48. Primary Outcome

Title	Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24
Description	All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	Participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening).
Measure Participants	73
At Baseline	6.56 (3.539)
At Week 24	4.29 (3.281)
Change from Baseline at Week 24	-2.32 (3.407)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.34
	Confidence Interval	(2-Sided) 95%; 1.743 to 2.943
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

49. Primary Outcome

Title	Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4
Description	All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.78 (1.677)
At Week 4	4.85 (1.598)
Change from Baseline at Week 4	-0.88 (1.805)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.474 to 1.295
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

50. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8
Description	All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.78 (1.677)
At Week 8	4.49 (1.720)
Change from Baseline at Week 8	-1.26 (1.968)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.28
	Confidence Interval	(2-Sided) 95%; 0.875 to 1.690
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

51. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12
Description	All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.78 (1.677)
At Week 12	4.01 (1.830)
Change from Baseline at Week 12	-1.73 (2.139)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.74
	Confidence Interval	(2-Sided) 95%; 1.333 to 2.145
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

52. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16
Description	All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.78 (1.677)
At Week 16	3.74 (1.809)
Change from Baseline at Week 16	-1.98 (2.042)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.96
	Confidence Interval	(2-Sided) 95%; 1.545 to 2.371
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

53. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20
Description	All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.78 (1.677)
At Week 20	3.67 (1.940)
Change from Baseline at Week 20	-2.06 (2.045)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs. Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.06
	Confidence Interval	(2-Sided) 95%; 1.643 to 2.469
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

54. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24
Description	All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.78 (1.677)
At Week 24	3.52 (1.791)
Change from Baseline at Week 24	-2.21 (2.116)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.21
	Confidence Interval	(2-Sided) 95%; 1.794 to 2.620
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

55. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4
Description	All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.93 (2.226)
At Week 4	4.69 (1.924)
Change from Baseline at Week 4	-1.22 (2.014)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.703 to 1.660
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

56. Primary Outcome

Title	Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8
Description	All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.93 (2.226)
At Week 8	4.51 (1.960)
Change from Baseline at Week 8	-1.45 (2.304)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95%; 0.977 to 1.926
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

57. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12
Description	All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and impact they had on participant's everyday life.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.93 (2.226)
At Week 12	3.99 (2.054)
Change from Baseline at Week 12	-1.94 (2.670)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.95
	Confidence Interval	(2-Sided) 95%; 1.473 to 2.418
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

58. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16
Description	All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.93 (2.226)
At Week 16	3.55 (1.773)
Change from Baseline at Week 16	-2.35 (2.657)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week16
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.33
	Confidence Interval	(2-Sided) 95%; 1.848 to 2.810
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

59. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20
Description	All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.93 (2.226)
At Week 20	3.70 (2.068)
Change from Baseline at Week 20	-2.20 (2.591)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs. Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.21
	Confidence Interval	(2-Sided) 95%; 1.732 to 2.694
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

60. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24
Description	All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	5.93 (2.226)
At Week 24	3.41 (1.848)
Change from Baseline at Week 24	-2.48 (2.562)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 Vs Week 24
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.50
	Confidence Interval	(2-Sided) 95%; 2.020 to 2.982
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

61. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4
Description	All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	Participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening).
Measure Participants	73
At Baseline	4.95 (2.040)
At Week 4	4.46 (1.861)
Change from Baseline at Week 4	-0.43 (1.885)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 4
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0786
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95%; -0.050 to 0.919
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

62. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8
Description	All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 8

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	4.95 (2.040)
At Week 8	4.29 (2.087)
Change from Baseline at Week 8	-0.67 (2.501)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 8
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0050
	Comments
	Method	ANOVA
	Comments	[1] From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95%; 0.210 to 1.171
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

63. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12
Description	All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	4.95 (2.040)
At Week 12	3.56 (1.878)
Change from Baseline at Week 12	-1.39 (2.373)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 12
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95%; 0.918 to 1.875
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

64. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16
Description	All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	4.95 (2.040)
At Week 16	3.47 (1.684)
Change from baseline at Week 16	-1.47 (2.374)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	[From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.44
	Confidence Interval	(2-Sided) 95%; 0.951 to 1.926
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

65. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20
Description	All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 20

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	4.95 (2.040)
At Week 20	3.76 (2.134)
Change from Baseline at Week 20	-1.17 (2.415)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments	Week 0 vs Week 20
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.17
	Confidence Interval	(2-Sided) 95%; 0.678 to 1.653
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

66. Primary Outcome

Title	Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24
Description	All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Time Frame	At Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.

Arm/Group Title	Stannous Fluoride
Arm/Group Description	This was a non-comparative design study, all the participants applied dentifrice containing stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
Measure Participants	73
At Baseline	4.95 (2.040)
At Week 24	3.36 (1.911)
Change from baseline at Week 24	-1.56 (2.620)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stannous Fluoride
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments	From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.56
	Confidence Interval	(2-Sided) 95%; 1.072 to 2.047
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value

Adverse Events

Time Frame	Baseline to Week 24
Arm/Group Title	Stannous Fluoride
Arm/Group Description	Participants will brush with a full brush head of toothpaste for 1 timed minute (in their usual manner), twice daily (morning and evening) from baseline
All Cause Mortality
	Stannous Fluoride
	Affected / at Risk (%)	# Events
Total	0/75 (0%)
Serious Adverse Events
	Stannous Fluoride
	Affected / at Risk (%)	# Events
Total	1/75 (1.3%)
Nervous system disorders
Syncope	1/75 (1.3%)
Other (Not Including Serious) Adverse Events
	Stannous Fluoride
	Affected / at Risk (%)	# Events
Total	47/75 (62.7%)
Ear and labyrinth disorders
EAR PAIN	1/75 (1.3%)
Gastrointestinal disorders
TOOTHACHE	5/75 (6.7%)
ORAL MUCOSAL EXFOLIATION	4/75 (5.3%)
ABDOMINAL PAIN LOWER	1/75 (1.3%)
ABDOMINAL PAIN UPPER	1/75 (1.3%)
CONSTIPATION	1/75 (1.3%)
GINGIVAL BLEEDING	21/75 (28%)
LIP EXFOLIATION	1/75 (1.3%)
LIP ULCERATION	2/75 (2.7%)
MOUTH ULCERATION	1/75 (1.3%)
NAUSEA	1/75 (1.3%)
ORAL MUCOSAL ERYTHEMA	2/75 (2.7%)
VOMITING	2/75 (2.7%)
APHTHOUS ULCER	1/75 (1.3%)
ORAL DISCOMFORT	1/75 (1.3%)
Infections and infestations
ORAL HERPES	12/75 (16%)
ORAL HERPES	7/75 (9.3%)
GASTROENTERITIS	4/75 (5.3%)
UPPER RESPIRATORY TRACT INFECTION	3/75 (4%)
HERPES VIRUS INFECTION	1/75 (1.3%)
OTITIS MEDIA	1/75 (1.3%)
TONSILLITIS BACTERIAL	1/75 (1.3%)
LOWER RESPIRATORY TRACT INFECTION	1/75 (1.3%)
PHARYNGITIS	1/75 (1.3%)
CONJUNCTIVITIS	1/75 (1.3%)
Injury, poisoning and procedural complications
PROCEDURAL PAIN	3/75 (4%)
TOOTH FRACTURE	3/75 (4%)
TOOTH INJURY	2/75 (2.7%)
ARTHROPOD BITE	1/75 (1.3%)
EYELID INJURY	1/75 (1.3%)
FACE INJURY	1/75 (1.3%)
HAND FRACTURE	1/75 (1.3%)
POST-TRAUMATIC NECK SYNDROME	1/75 (1.3%)
ROAD TRAFFIC ACCIDENT	1/75 (1.3%)
TRAUMATIC ULCER	1/75 (1.3%)
MOUTH INJURY	1/75 (1.3%)
Metabolism and nutrition disorders
HYPERGLYCAEMIA	1/75 (1.3%)
Musculoskeletal and connective tissue disorders
BACK PAIN	2/75 (2.7%)
MUSCULOSKELETAL PAIN	1/75 (1.3%)
ARTHRALGIA	1/75 (1.3%)
Nervous system disorders
HEADACHE	12/75 (16%)
Product Issues
DEVICE FAILURE	3/75 (4%)
Respiratory, thoracic and mediastinal disorders
ASTHMA	2/75 (2.7%)
Skin and subcutaneous tissue disorders
SKIN ULCER	1/75 (1.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.