A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Overview
- Phase
- Phase 3
- Intervention
- Stannous Fluoride
- Conditions
- Dentine Hypersensitivity
- Sponsor
- GlaxoSmithKline
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who suffer from tooth sensitivity
- •Inclusion Criteria:
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
Dentifrice containing stannous fluoride
Intervention: Stannous Fluoride
Arm 2
Marketed dentifrice containing Sodium Monofluorophosphate
Intervention: Sodium Monofluorophosphate
Outcomes
Primary Outcomes
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
Time Frame: Baseline to 8 weeks post administration of study treatment
Response to a constant jet of air applied to hypersensitive teeth is 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.
Secondary Outcomes
- Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4(Baseline to 4 weeks post administration of study treatment)
- Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8(Baseline to 8 weeks post administration of study treatment)
- Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4(Baseline to 4 weeks post administration of study treatment)