A Pilot Clinical Study Investigating the Efficacy of a Toothpaste in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity
Overview
- Phase
- Not Applicable
- Intervention
- Test Toothpaste
- Conditions
- Dentinal Sensitivity
- Sponsor
- GlaxoSmithKline
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Toothpaste containing 0.454% stannous fluoride
USA marketed toothpaste \[test\]
Intervention: Test Toothpaste
Toothpaste containing 0.76% sodium monofluorophosphate
USA marketed toothpaste \[negative control\]
Intervention: Negative Control Toothpaste
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
Time Frame: Baseline and immediately after treatment administration
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.
Secondary Outcomes
- Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3(Baseline and Day 3)
- Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14(Baseline and Day 14)
- Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment(Baseline and immediately after treatment administration)
- Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3(Baseline and Day 3)
- Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14(Baseline and Day 14)