Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

Study Overview
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Brief Summary
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The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

Detailed Description
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This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design 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, four and eight weeks to monitor clinical efficacy and safety.

Official Title
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A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity

Conditions
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Dentinal Hypersensitivity

Intervention / Treatment
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* Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
* Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
* Drug: Sodium monofluorophosphate dentifrice
* Drug: Sodium Fluoride dentifrice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study. Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit. Exclusion Criteria: Specific Dentition Exclusions for Test teeth Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening. Tooth with exposed dentin 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 etiologies other than erosion, abrasion or recession of exposed dentin. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator Use of a sensitivity dentifrice within 8 weeks of screening Individuals who require antibiotic prophylaxis for dental procedures

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate<br>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate | Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice<br>* Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate<br>|
| Active Comparator: 0% calcium sodium phosphosilicate/sodium monofluorophosphate<br>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate | Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice<br>* No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate<br>|
| Active Comparator: Sodium monofluorophosphate<br>Dentifrice containing 1000 ppmF as sodium monofluorophosphate | Drug: Sodium monofluorophosphate dentifrice<br>* Sodium monofluorophospate dentifrice (1000 ppm F)<br>|
| Active Comparator: Sodium fluoride<br>Dentifrice containing 1100 ppmF as sodium fluoride | Drug: Sodium Fluoride dentifrice<br>* Dentifrice containing 1100ppm F as sodium fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. | Baseline and 4 weeks post administration of study treatment | 
| Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. | Baseline and 8 weeks post administration of study treatment | 
| Median Change From Baseline in Tactile Sensitivity at Week 4 | 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 and 4 weeks post administration of study treatment | 
| Median Change From Baseline in Tactile Sensitivity at Week 8 | 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 and 8 weeks post administration of study treatment | 
| Mean Change From Baseline in Visual Rating Scale Score at Week 4 | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain. | Baseline and 4 weeks post administration of study treatment | 
| Mean Change From Baseline in Visual Rating Scale Score at Week 8 | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain. | Baseline and 8 weeks post administration of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. | Baseline and 4 weeks post administration of study treatment | 
| Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. | Baseline and 8 weeks post administration of study treatment |