A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02753075
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 3
• Duration (Months): 3.3
• Patients Per Site Per Month: 72.3

Study Details

Study Description

Brief Summary

This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, 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: 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 8, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 18, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Oral Rinse 1 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; Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5; Drug: Fluoride toothpaste; Oral rinse containing 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; Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5; Drug: Fluoride toothpaste; Oral rinse containing 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; Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5; Drug: Fluoride toothpaste; Oral rinse containing 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 selected two teeth 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 selected two teeth 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 selected two teeth 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, 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, 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, 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:

• Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon oral examination

• Pre-existing self reported and clinically diagnosed tooth sensitivity

• At screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) preferably in different quadrants with a 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 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).

• At baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)

Exclusion Criteria:

• Participants with a known or suspected intolerance or hypersensitivity to study products

• Presence of chronic debilitating disease which could affect study outcomes

• Any condition which is causing dry mouth

• Use of an oral care product indicated for the relief of dentine hypersensitivity

• Participation in a DH treatment study in the 8 weeks prior to screening

• Taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth

• Require antibiotic prophylaxis for dental procedures

• Dental prophylaxis within 4 weeks of screening

• Treatment of periodontal disease within 12 months of screening

• Scaling or root planning within 3 months of screening

• Tooth bleaching within 8 weeks of screening

• Active caries or periodontitis

• Partial dentures, orthodontic appliances or dental implants which could affect study outcomes

• Pregnant and breast-feeding females

• Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Fort Wayne	Indiana	United States	46825

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: NCT02753075
• Other Study ID Numbers: 204773
• First Posted: Apr 27, 2016
• Last Update Posted: Aug 27, 2018
• Last Verified: Jul 1, 2018

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

Study Results

Participant Flow

Pre-assignment Detail	A total of 283 participants were screened, out of which 240 participants were randomized.

Arm/Group Title	Experimental Oral Rinse 1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F]) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Period Title: Overall Study
STARTED	79	80	81
COMPLETED	71	77	78
NOT COMPLETED	8	3	3

Baseline Characteristics

Arm/Group Title	Experimental Oral Rinse 1	Experimental Oral Rinse 2	Placebo Oral Rinse	Total
Arm/Group Description	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. 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]	40.5 (9.00)	40.0 (9.81)	40.5 (8.71)	40.3 (9.15)
Sex: Female, Male (Count of Participants)
Female	67 84.8%	72 90%	70 86.4%	209 87.1%
Male	12 15.2%	8 10%	11 13.6%	31 12.9%

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 selected two teeth 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 Rinse 1	Experimental Oral Rinse 2	Placebo Oral Rinse
Arm/Group Description	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Measure Participants	71	77	78
At Baseline	2.53 (0.422)	2.55 (0.415)	2.55 (0.416)
Change from Baseline at Week 8	-1.19 (1.097)	-1.29 (0.961)	-1.28 (1.031)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8290
	Comments	For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Square (LS) mean difference
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.289 to 0.461
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment as factor and baseline Schiff score 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	0.9993
	Comments	For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.372 to 0.362
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.

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 selected two teeth 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 are 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
Arm/Group Description	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Measure Participants	71	77
At Baseline	2.53 (0.422)	2.55 (0.415)
Change from Baseline at Week 8	-1.19 (1.097)	-1.29 (0.961)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5892
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.242 to 0.424
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate. 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 selected two teeth 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 are 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	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Measure Participants	77	79	79
At Baseline	2.54 (0.420)	2.54 (0.417)	2.54 (0.417)
Change from Baseline at Week 4	-0.71 (0.864)	-0.83 (0.738)	-0.85 (0.825)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2825
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; -0.116 to 0.396
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment as factor and baseline Schiff score 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	0.8448
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -0.229 to 0.280
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment as factor and baseline Schiff score 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 Rinse 1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3784
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -0.141 to 0.371
	Parameter Dispersion	Type: Value:
	Estimation Comments	From ANCOVA model with treatment as factor and baseline Schiff score as covariate. 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, 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 are 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	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Measure Participants	77	79	79
At Baseline	10.00	10.00	10.00
Change from Baseline at Week 4	15.00	10.00	5.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1688
	Comments	Wilcoxon rank sum test.
	Method	Wilcoxon rank sum test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -10.00 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. Median Difference has been calculated 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	0.4380
	Comments	Wilcoxon rank sum test.
	Method	Wilcoxon rank sum 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. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5693
	Comments	Wilcoxon rank sum test.
	Method	Wilcoxon rank sum 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. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.

5. Secondary Outcome

Title	Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 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 are 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	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Measure Participants	71	77	78
At Baseline	10.00 (1.187)	10.00 (1.737)	10.00 (1.971)
Change from Baseline at Week 8	40.00 (30.932)	40.00 (30.754)	40.00 (32.873)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7789
	Comments	Wilcoxon rank sum test.
	Method	Wilcoxon rank sum 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 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	0.7214
	Comments	Wilcoxon rank sum test.
	Method	Wilcoxon rank sum 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 Rinse 1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8960
	Comments	Wilcoxon rank sum test.
	Method	Wilcoxon rank sum test
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -5.000 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, 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 are 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	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Measure Participants	77	79	79
At Baseline	6.88 (1.670)	6.96 (1.472)	6.72 (1.692)
Change from Baseline at Week 4	-1.57 (1.699)	-1.84 (1.698)	-1.97 (1.819)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0978
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 95%; -0.084 to 0.987
	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	0.4607
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 95%; -0.333 to 0.732
	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 Rinse 1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3542
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; -0.283 to 0.787
	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 are 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	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.	Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
Measure Participants	71	77	78
At Baseline	6.92 (1.626)	6.92 (1.471)	6.72 (1.703)
Change from Baseline at Week 8	-2.63 (2.257)	-2.73 (2.096)	-2.54 (2.325)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental Oral Rinse 1, Placebo Oral Rinse
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9474
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.665 to 0.711
	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	0.7987
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -0.760 to 0.586
	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 Rinse 1, Experimental Oral Rinse 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7525
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -0.578 to 0.798
	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	Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F], pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.		Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F, pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.		Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. 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	10/79 (12.7%)		8/80 (10%)		2/81 (2.5%)
Gastrointestinal disorders
ORAL DISCOMFORT	4/79 (5.1%)		2/80 (2.5%)		0/81 (0%)
DRY MOUTH	3/79 (3.8%)		2/80 (2.5%)		0/81 (0%)
GINGIVAL PAIN	2/79 (2.5%)		1/80 (1.3%)		0/81 (0%)
HYPOAESTHESIA ORAL	2/79 (2.5%)		0/80 (0%)		0/81 (0%)
GLOSSODYNIA	1/79 (1.3%)		3/80 (3.8%)		0/81 (0%)
LIP EXFOLIATION	1/79 (1.3%)		0/80 (0%)		0/81 (0%)
LIP SWELLING	1/79 (1.3%)		0/80 (0%)		0/81 (0%)
ORAL MUCOSAL EXFOLIATION	0/79 (0%)		0/80 (0%)		1/81 (1.2%)
PARAESTHESIA ORAL	0/79 (0%)		1/80 (1.3%)		0/81 (0%)
TOOTH DISORDER	0/79 (0%)		1/80 (1.3%)		0/81 (0%)
Injury, poisoning and procedural complications
TRAUMATIC ULCER	2/79 (2.5%)		0/80 (0%)		1/81 (1.2%)

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.