Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity

Study Overview
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Brief Summary
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An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.

Detailed Description
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A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.

Official Title
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A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity

Conditions
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Dentine Sensitivity

Intervention / Treatment
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* Device: Calcium sodium phosphosilicate
* Other: Sodium fluoride
* Other: Sodium monofluorophosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects in good general health with no clinically significant/ relevant abnormalities of 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) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment 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: subjects 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+C60 scaling or root planing 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test dentifrice<br>Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium flouride | Device: Calcium sodium phosphosilicate<br>* 5% w/w calcium sodium phosphosilicate<br>Other: Sodium fluoride<br>* 1426 ppm fluoride as sodium fluoride<br>|
| Active Comparator: Comparator dentifrice<br>Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate | Device: Calcium sodium phosphosilicate<br>* 5% w/w calcium sodium phosphosilicate<br>Other: Sodium monofluorophosphate<br>* 1426 ppm fluoride as sodium monofluorophosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | At Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | At Baseline and Week 4 | 
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | Evaporative air sensitivity was measured by examiner as 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. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | At Baseline, Week 4 and Week 8 | 
| Change From Baseline in Tactile Threshold at Week 4 and Week 8 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. 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. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | At Baseline, Week 4 and Week 8 |