Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.

Official Title
-----------------
A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

Conditions
-----------------
Dentin Sensitivity

Intervention / Treatment
-----------------
* Drug: Potassium nitrate and sodium fluoride
* Drug: Standard fluoride dentifrice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years. Participants with minimum of 20 natural teeth. At screening, a minimum of four, non-adjacent teeth. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1. Teeth that are determined to be sensitive by the participant following a 1 second air blast to the cervical margin. Exclusion Criteria: 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 dry mouth. Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potassium nitrate and sodium fluoride<br>3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride | Drug: Potassium nitrate and sodium fluoride<br>* 3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride<br>|
| Other: Standard fluoride dentifrice<br>Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP) | Drug: Standard fluoride dentifrice<br>* Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | The examiner indicated the participant's response to an evaporaitve 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 is indicative of an imrpovement in sensitivity. | Baseline to 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | The examiner indicated the participant's response to an evaporaitve 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 is indicative of an imrpovement in sensitivity. | Baseline to 4 week | 
| Mean Change From Baseline in Tactile Threshold at 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 was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject 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. | Baseline to 8 week | 
| Mean Change From Baseline in Tactile Threshold at 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 was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject 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. | Baseline to 4 week | 
| Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8 | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. | Baseline to 8 week | 
| Mean Change From Baseline in VRS at Week 4 | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. | Baseline to 4 week |