Exploratory Study to Evaluate 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 arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory 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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Dentine 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: Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Breast-feeding: Women who are breast-feeding. Medical History: a) Chronic debilitating disease is present b) Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc. Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter dentifrice in the opinion of the investigator. b) 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, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit b) Previous participation in this study. Other: Any subject who in the opinion of the investigator, should not participate in the study.

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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No

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: Double


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 with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF). | Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice<br>* Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF 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>* Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate<br>|
| Active Comparator: Sodium monofluorophosphate<br>Dentifrice containing 1000 ppmF as sodium monofluorophosphate | Drug: Sodium monofluorophosphate dentifrice<br>* Dentifrice containing 1000 ppmF as sodium monofluorophosphate<br>|
| Active Comparator: Sodium fluoride<br>Dentifrice containing 1100 ppmF as sodium fluoride | Drug: Sodium fluoride dentifrice<br>* Dentifrice containing 1100 ppmF as sodium fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. | Baseline to 4 weeks post administration of study treatment | 
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. | Baseline to 4 weeks post administration of study treatment | 
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. | Baseline to 8 weeks post administration of study treatment | 
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. | Baseline to 8 weeks post administration of study treatment | 
| Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain). | Baseline to 4 weeks post administration of study treatment | 
| Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain). | Baseline to 8 weeks post administration of study treatment |