A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

• Sponsor: Procter and Gamble (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03965039
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 42

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.

Condition or Disease	Intervention/Treatment	Phase
Dentin Hypersensitivity	Device: Dipotassium oxalate toothpaste; Drug: Stannous fluoride toothpaste; Drug: Potassium nitrate toothpaste; Drug: Sodium monofluorophosphate toothpaste	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
• Actual Study Start Date: Jul 8, 2019
• Actual Primary Completion Date: Oct 3, 2019
• Actual Study Completion Date: Oct 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Marketed stannous fluoride toothpaste Brush twice daily	Drug: Stannous fluoride toothpaste; Marketed stannous fluoride (0.454%) toothpaste
Active Comparator: Marketed potassium nitrate toothpaste Brush Twice Daily	Drug: Potassium nitrate toothpaste; Marketed potassium nitrate (5%) toothpaste
Placebo Comparator: Marketed sodium monofluorophosphate toothpaste Brush Twice Daily	Drug: Sodium monofluorophosphate toothpaste; Marketed sodium monofluorophosphate (0.76%) toothpaste
Experimental: Experimental dipotassium oxalate toothpaste Brush Twice Daily	Device: Dipotassium oxalate toothpaste; Experimental dipotassium oxalate (3%) toothpaste

Outcome Measures

Primary Outcome Measures

1. Air Challenge [4 weeks]

   The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Secondary Outcome Measures

1. Baseline Air Challenge [Baseline]

   The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.

2. Air Challenge [3 days]

   The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

3. Air Challenge [2 weeks]

   The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

4. Air Challenge [8 weeks]

   The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

5. Air Challenge [11 weeks]

   The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11).

6. Baseline Yeaple Probe [Baseline]

   Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.

7. Tactile Threshold [3 days]

   Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

8. Tactile Threshold [2 weeks]

   Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

9. Tactile Threshold [4 weeks]

   Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

10. Tactile Threshold [8 weeks]

    Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

11. Tactile Threshold [11 weeks]

    Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• be at least 18 years of age;

• provide written informed consent prior to participation and be given a signed copy of the informed consent form;

• sign a Confidentiality Disclosure Agreement (CDA);

• be in good general health as determined by the Investigator/designee;

• agree not to participate in any other oral/dental product studies during the course of this study;

• agree to delay any dentistry (including dental prophylaxis) until the study has been completed;

• agree to refrain from the use of any non-study oral hygiene products*;

• exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);

• have an absence of extensive calculus above the gum line;

• agree to return for all scheduled visits and follow study procedures; and

• have two teeth with a Schiff sensitivity score > 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.)

Exclusion Criteria:

• having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically;

• chronic medical debilitating disease associated with constant or intermittent episodes of daily pain;

• any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit;

• dental prophylaxis within 2 weeks prior to Baseline visit;

• having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit;

• having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months;

• having teeth or periodontium with pathology or defects likely to cause pain;

• having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics;

• self-reported pregnancy or lactation;

• having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;

• history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;

• any diseases or condition that might interfere with the safe participation in the study;

• inability to undergo study procedures;

• having severe xerostomia;

• having had active caries within the 12 months;

• having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion;

• teeth will be excluded from study measurements if they:

• have deep, defective, or facial restorations;

• have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;

• present with tendency for spontaneous bleeding;

• have been scaled/root planed or restored within the past 3 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Silverstone Research Group	Las Vegas	Nevada	United States	89146

Sponsors and Collaborators

• Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 23, 2019

More Information

Publications

None provided.

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT03965039
• Other Study ID Numbers: 2019079
• First Posted: May 28, 2019
• Last Update Posted: Oct 30, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Dentin Sensitivity; Hypersensitivity; Fluorides; Tin Fluorides; Fluorophosphate

Study Results

Participant Flow

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Period Title: Overall Study
STARTED	30	30	30	30
COMPLETED	30	29	30	29
NOT COMPLETED	0	1	0	1

Baseline Characteristics

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste	Total
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste	Total of all reporting groups
Overall Participants	30	30	30	30	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.73 (11.52)	42.53 (13.28)	39.03 (11.04)	39.87 (10.42)	40.04 (11.56)
Sex: Female, Male (Count of Participants)
Female	22 73.3%	21 70%	21 70%	22 73.3%	86 71.7%
Male	8 26.7%	9 30%	9 30%	8 26.7%	34 28.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 16.7%	7 23.3%	6 20%	7 23.3%	25 20.8%
Not Hispanic or Latino	25 83.3%	23 76.7%	24 80%	23 76.7%	95 79.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 3.3%	0 0%	1 0.8%
Asian	5 16.7%	1 3.3%	2 6.7%	1 3.3%	9 7.5%
Native Hawaiian or Other Pacific Islander	1 3.3%	0 0%	0 0%	0 0%	1 0.8%
Black or African American	3 10%	2 6.7%	7 23.3%	7 23.3%	19 15.8%
White	20 66.7%	24 80%	15 50%	15 50%	74 61.7%
More than one race	1 3.3%	3 10%	5 16.7%	7 23.3%	16 13.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Air Challenge
Description	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	30	28
Least Squares Mean (Standard Error) [score on a scale]	1.17 (0.141)	1.48 (0.087)	2.26 (0.066)	1.39 (0.116)

2. Secondary Outcome

Title	Baseline Air Challenge
Description	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	30	30
Mean (Standard Deviation) [score on a scale]	2.45 (0.379)	2.40 (0.381)	2.52 (0.382)	2.45 (0.356)

3. Secondary Outcome

Title	Air Challenge
Description	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	29	30
Least Squares Mean (Standard Error) [score on a scale]	1.93 (0.081)	2.05 (0.085)	2.36 (0.062)	1.88 (0.085)

4. Secondary Outcome

Title	Air Challenge
Description	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	30	29
Least Squares Mean (Standard Error) [score on a scale]	1.44 (0.117)	1.78 (0.092)	2.24 (0.074)	1.61 (0.103)

5. Secondary Outcome

Title	Air Challenge
Description	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	29	30	29
Least Squares Mean (Standard Error) [score on a scale]	0.96 (0.144)	1.24 (0.094)	2.22 (0.059)	1.18 (0.134)

6. Secondary Outcome

Title	Air Challenge
Description	The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11).
Time Frame	11 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	29	30	29
Least Squares Mean (Standard Error) [score on a scale]	1.32 (0.147)	1.40 (0.121)	2.18 (0.071)	1.32 (0.145)

7. Secondary Outcome

Title	Baseline Yeaple Probe
Description	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	30	30
Mean (Standard Deviation) [score on a scale]	10.33 (1.826)	10.50 (1.526)	11.00 (2.754)	10.50 (2.013)

8. Secondary Outcome

Title	Tactile Threshold
Description	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	29	30
Least Squares Mean (Standard Error) [score on a scale]	16.70 (1.039)	13.74 (0.704)	12.41 (0.741)	15.90 (1.240)

9. Secondary Outcome

Title	Tactile Threshold
Description	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	30	29
Least Squares Mean (Standard Error) [score on a scale]	22.70 (1.987)	18.57 (1.528)	14.17 (1.022)	21.61 (1.533)

10. Secondary Outcome

Title	Tactile Threshold
Description	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	30	30	28
Least Squares Mean (Standard Error) [score on a scale]	26.76 (2.548)	22.76 (1.710)	13.93 (0.988)	25.06 (1.556)

11. Secondary Outcome

Title	Tactile Threshold
Description	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	29	30	29
Least Squares Mean (Standard Error) [score on a scale]	29.30 (2.728)	27.45 (1.926)	13.45 (0.824)	28.49 (2.044)

12. Secondary Outcome

Title	Tactile Threshold
Description	Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11).
Time Frame	11 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Marketed Stannous Fluoride Toothpaste	Marketed Potassium Nitrate Toothpaste	Marketed Sodium Monofluorophosphate Toothpaste	Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Measure Participants	30	29	30	29
Least Squares Mean (Standard Error) [score on a scale]	24.75 (2.631)	21.92 (1.801)	12.71 (0.664)	24.85 (1.863)

Adverse Events

Time Frame	Adverse event data were collected for all 11 weeks of the study for each intervention.
Arm/Group Title	Marketed Stannous Fluoride Toothpaste		Marketed Potassium Nitrate Toothpaste		Marketed Sodium Monofluorophosphate Toothpaste		Experimental Dipotassium Oxalate Toothpaste
Arm/Group Description	Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste		Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste		Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste		Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
All Cause Mortality
	Marketed Stannous Fluoride Toothpaste		Marketed Potassium Nitrate Toothpaste		Marketed Sodium Monofluorophosphate Toothpaste		Experimental Dipotassium Oxalate Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Marketed Stannous Fluoride Toothpaste		Marketed Potassium Nitrate Toothpaste		Marketed Sodium Monofluorophosphate Toothpaste		Experimental Dipotassium Oxalate Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Marketed Stannous Fluoride Toothpaste		Marketed Potassium Nitrate Toothpaste		Marketed Sodium Monofluorophosphate Toothpaste		Experimental Dipotassium Oxalate Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		5/30 (16.7%)		0/30 (0%)		3/30 (10%)
Gastrointestinal disorders
Desquamation Mouth	0/30 (0%)		1/30 (3.3%)		0/30 (0%)		1/30 (3.3%)
Mouth Injury	0/30 (0%)		4/30 (13.3%)		0/30 (0%)		3/30 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

PI should disclose plans to sponsor prior to public release.