NCT03361774

A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity

A Clinical Method Development Study to Characterise The Efficacy of An Experimental Dual Active Combination Dentifrice For The Relief Of Dentin Hypersensitivity

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to develop the clinical methodology to characterize the efficacy profiles of an experimental 5% potassium nitrate (KNO3) and 0.454% stannous fluoride (SnF2) combination dentifrice and a marketed desensitizing 0.454% SnF2 only dentifrice for the relief of dentin hypersensitivity (DH), at multiple time points, 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), method development study, in participants in good general health, with pre-existing self-reported tooth sensitivity, and at least two sensitive teeth (diagnosed clinically) that meet all study criteria at the screening and baseline (pre-treatment) visits.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DRUG	Dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride).	Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth. Participants will be permitted to rinse with tap water post-brushing if they wish to.
DRUG	Dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride).	Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth. Participants will be permitted to rinse with tap water post-brushing if they wish to.

Timeline

• Start date: 2018-10-01
• Primary completion: 2018-12-03
• Completion: 2018-12-03
• First posted: 2017-12-05
• Last updated: 2019-02-15

Regulatory

• FDA-regulated drug study