drugset / Trial / NCT02226562

Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

NCT02226562

Phase 2 Completed 191 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.

Timeline

Start
2014-09-02
Primary completion
2014-12-01
Completion
2014-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Potassium Nitrate Other / unclassified 3 % Oral
Background SMFP Unknown 1000 ppm Oral
Background sodium fluoride Unknown 0.02 % Oral

Indications