A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dentine Sensitivity
- Sponsor
- GlaxoSmithKline
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
Time Frame: At Baseline and 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.
Secondary Outcomes
- Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8(At Baseline, Week 4 and Week 8)
- Change From Baseline in Tactile Threshold at Week 4 and Week 8(At Baseline, Week 4 and Week 8)
- Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4(At Baseline and Week 4)