Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02542943
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 80.3

Study Details

Study Description

Brief Summary

This study will investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Condition or Disease	Intervention/Treatment	Phase
Dentin Sensitivity	Device: Experimental Oral Rinse 1; Device: Experimental Oral Rinse 2; Other: Placebo Oral Rinse; Drug: Standard fluoride toothpaste	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Oral Rinse1 Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks.	Device: Experimental Oral Rinse 1; (1.5% w/w KOX, pH 4.5); Drug: Standard fluoride toothpaste; 1000ppm fluoride as sodium monofluorophosphate
Experimental: Experimental Oral Rinse 2 Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.	Device: Experimental Oral Rinse 2; (1.5% w/w KOX, pH 7); Drug: Standard fluoride toothpaste; 1000ppm fluoride as sodium monofluorophosphate
Placebo Comparator: Placebo Oral Rinse Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.	Other: Placebo Oral Rinse; (0% w/w KOX, pH 4.5); Drug: Standard fluoride toothpaste; 1000ppm fluoride as sodium monofluorophosphate

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 [Baseline, Week 8]

   The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.

Secondary Outcome Measures

1. Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8 [Baseline, Week 8]

   The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.

2. Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 [Baseline, Week 4]

   The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.

3. Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 [Baseline, Week 4]

   The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.

4. Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8 [Baseline, Week 8]

   The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.

5. Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4 [Baseline, Week 4]

   Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.

6. Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 [Baseline, Week 8]

   Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.

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 procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form

• Aged between 18 and 55 years inclusive

• Good general and mental health with, in the opinion of the investigator or medically qualified designee:

1. No clinically significant and relevant abnormalities in medical history or upon oral examination.

2. Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.

• Dental health

At Screening:

1. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.

2. Good general oral health, with a minimum of 20 natural teeth.

3. 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 modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.

• Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).

At Baseline:

1. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:

• Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)

Exclusion Criteria:

• Pregnant or breast feeding women

• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.

• Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.

• Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.

• Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.

• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.

• Any condition which, in the opinion of the investigator, causes xerostomia.

• Treatment of periodontal disease within 12 months of screening

• 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.

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

• Dental prophylaxis within four weeks of Screening.

• Tongue or lip piercing or presence of dental implants.

• Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste 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.

• Teeth bleaching within eight 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.

• Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the investigator.

• Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening

• Individuals who require antibiotic prophylaxis for dental procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Las Vegas	Nevada	United States	89146

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02542943
• Other Study ID Numbers: 204762
• First Posted: Sep 7, 2015
• Last Update Posted: Mar 6, 2017
• Last Verified: Jan 1, 2017

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

Study Results

Participant Flow

Pre-assignment Detail	A total of 262 participants were screened, out of which 240 participants were randomized and 238 completed the study.

Arm/Group Title	Experimental Oral Rinse 1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% weight by weight (w/w) dipotasium oxalate monohydrate [KOX], pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
Period Title: Overall Study
STARTED	79	80	81
COMPLETED	78	79	81
NOT COMPLETED	1	1	0

Baseline Characteristics

Arm/Group Title	Experimental Oral Rinse1	Experimental Oral Rinse 2	Placebo Oral Rinse	Total
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Total of all reporting groups
Overall Participants	79	80	81	240
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	34.8 (10.45)	35.0 (8.41)	36.5 (10.07)	35.4 (9.67)
Gender (Count of Participants)
Female	51 64.6%	53 66.3%	56 69.1%	160 66.7%
Male	28 35.4%	27 33.8%	25 30.9%	80 33.3%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
Description	The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Experimental Oral Rinse1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
Measure Participants	78	79	81
At Baseline	2.54 (0.420)	2.56 (0.416)	2.55 (0.415)
Change from Baseline at Week 8	-0.86 (0.772)	-0.66 (0.803)	-0.73 (0.779)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4350
	Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least square (LS) mean difference
	Estimated Value	-0.13
	Confidence Interval	(2-Sided) 95%; -0.400 to 0.134
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 2, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7605
	Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.192 to 0.340
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.

2. Secondary Outcome

Title	Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
Description	The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Experimental Oral Rinse1	Experimental Oral Rinse 2
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
Measure Participants	78	79
At Baseline	2.54 (0.420)	2.56 (0.416)
Change from Baseline at Week 8	-0.86 (0.772)	-0.66 (0.803)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0873
	Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.445 to 0.031
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

3. Secondary Outcome

Title	Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Description	The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Experimental Oral Rinse 1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
Measure Participants	78	79	81
At Baseline	2.54 (0.420)	2.56 (0.416)	2.55 (0.415)
Change from Baseline at Week 4	-0.63 (0.701)	-0.56 (0.670)	-0.57 (0.732)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4921
	Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95%; -0.270 to 0.130
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 2, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8728
	Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.183 to 0.216
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4003
	Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -0.287 to 0.115
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

4. Secondary Outcome

Title	Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Description	The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Experimental Oral Rinse1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
Measure Participants	78	79	81
At Baseline	10.00 (0.000)	10.00 (0.000)	10.00 (0.000)
Change from Baseline at Week 4	5.00 (16.371)	0.00 (14.692)	5.00 (13.219)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8106
	Comments	From Van Elteren test.
	Method	Van Elteren test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; 0.000 to 0.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 2, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1656
	Comments	From Van Elteren test.
	Method	Van Elteren test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -5.000 to 0.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1419
	Comments
	Method	Van Elteren test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; 0.000 to 5.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.

5. Secondary Outcome

Title	Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8
Description	The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Experimental Oral Rinse1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
Measure Participants	78	79	81
At Baseline	10.00	10.00	10.00
Change from Baseline at Week 8	7.50	5.00	5.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5631
	Comments	From Van Elteren test.
	Method	Van Elteren test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; 0.000 to 5.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 2, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8423
	Comments	From Van Elteren test.
	Method	Van Elteren test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; 0.000 to 0.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4390
	Comments	From Van Elteren test.
	Method	Van Elteren test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; 0.000 to 5.000
	Parameter Dispersion	Type: Value:
	Estimation Comments	Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.

6. Secondary Outcome

Title	Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4
Description	Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Experimental Oral Rinse1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
Measure Participants	78	79	81
At Baseline	6.22 (1.515)	6.32 (1.209)	6.19 (1.422)
Change from Baseline at Week 4	-1.60 (1.476)	-1.29 (1.669)	-1.45 (1.505)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5170
	Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 95%; -0.611 to 0.308
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 2, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4538
	Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95%; -0.284 to 0.633
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1663
	Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -0.788 to 0.136
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

7. Secondary Outcome

Title	Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Description	Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.

Arm/Group Title	Experimental Oral Rinse1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
Measure Participants	78	79	81
At Baseline	6.22 (1.515)	6.32 (1.209)	6.19 (1.422)
Change from Baseline at Week 8	-2.25 (1.781)	-2.07 (1.820)	-2.15 (1.865)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7137
	Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.661 to 0.453
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 2, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7353
	Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.10
	Confidence Interval	(2-Sided) 95%; -0.460 to 0.651
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4843
	Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.760 to 0.361
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

Adverse Events

Arm/Group Title	Experimental Oral Rinse 1		Experimental Oral Rinse 2		Placebo Oral Rinse
Arm/Group Description	Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.		Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.		Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
All Cause Mortality
	Experimental Oral Rinse 1		Experimental Oral Rinse 2		Placebo Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Experimental Oral Rinse 1		Experimental Oral Rinse 2		Placebo Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/80 (0%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	Experimental Oral Rinse 1		Experimental Oral Rinse 2		Placebo Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/79 (13.9%)		13/80 (16.3%)		11/81 (13.6%)
Gastrointestinal disorders
SENSITIVITY OF TEETH	5/79 (6.3%)		7/80 (8.8%)		8/81 (9.9%)
ORAL MUCOSAL EXFOLIATION	3/79 (3.8%)		2/80 (2.5%)		0/81 (0%)
DENTAL DISCOMFORT	1/79 (1.3%)		0/80 (0%)		1/81 (1.2%)
TOOTHACHE	1/79 (1.3%)		0/80 (0%)		1/81 (1.2%)
CHAPPED LIPS	0/79 (0%)		0/80 (0%)		1/81 (1.2%)
LEUKOPLAKIA ORAL	0/79 (0%)		1/80 (1.3%)		0/81 (0%)
Infections and infestations
NASOPHARYNGITIS	0/79 (0%)		2/80 (2.5%)		0/81 (0%)
BRONCHITIS	1/79 (1.3%)		0/80 (0%)		0/81 (0%)
Injury, poisoning and procedural complications
THERMAL BURN	0/79 (0%)		1/80 (1.3%)		1/81 (1.2%)
TRAUMATIC ULCER	0/79 (0%)		1/80 (1.3%)		0/81 (0%)
Respiratory, thoracic and mediastinal disorders
COUGH	1/79 (1.3%)		0/80 (0%)		0/81 (0%)

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.