A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity
Overview
- Phase
- Phase 3
- Intervention
- Stannous Fluoride
- Conditions
- Dentine Hypersensitivity
- Sponsor
- GlaxoSmithKline
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Schiff Sensitivity Score on Day 14
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dentifrice containing stannous fluoride
Toothpaste
Intervention: Stannous Fluoride
Dentifrice containing Sodium Monofluorophosphate
Toothpaste
Intervention: Sodium Monofluorophosphate
Outcomes
Primary Outcomes
Change From Baseline in Schiff Sensitivity Score on Day 14
Time Frame: Baseline, Day 14
Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 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 indicates improvement in sensitivity.
Secondary Outcomes
- Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14(Baseline, post first brushing (after 5 minutes), Day 3 and Day 14)
- Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3(Baseline, post first brushing (after 5 minutes) and Day 3)