A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Short Term Relief From Dentinal Hypersensitivity
Overview
- Phase
- Phase 3
- Intervention
- Stannous Fluoride
- Conditions
- Dentine Hypersensitivity
- Sponsor
- GlaxoSmithKline
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14
Time Frame: Baseline to Day 14
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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.
Secondary Outcomes
- Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment(Baseline to immediately post treatment administration)
- Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3(Baseline to Day 3)
- Change From Baseline in Tactile Pain Threshold Score at Day 14(Baseline to Day 14)
- Change From Baseline in Tactile Pain Threshold Score at Day 3(Baseline to Day 3)
- Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment(Baseline to immediately post treatment administration)