NCT03943095

Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity

Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.

Detailed description

This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth), Phase II, exploratory clinical study in healthy participants with DH. It is hypothesized that the combination of two antisensitivity active ingredients with complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride: dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either active alone.

Conditions

• Dentin Hypersensitivity
• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	Potassium Nitrate	The test dentifrice contains 5% w/w potassium nitrate.
OTHER	Stannous Fluoride	The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).

Timeline

• Start date: 2019-05-13
• Primary completion: 2019-08-28
• Completion: 2019-08-28
• First posted: 2019-05-09
• Last updated: 2020-09-11
• Results posted: 2020-09-11

Locations

1 site across 1 country: Canada