NCT02226562

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DRUG	Potassium nitrate and sodium fluoride	3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride
DRUG	Standard fluoride dentifrice	Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP

Timeline

• Start date: 2014-09-02
• Primary completion: 2014-12-01
• Completion: 2014-12-05
• First posted: 2014-08-27
• Last updated: 2018-08-27
• Results posted: 2015-08-26

Locations

1 site across 1 country: United States