At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
In Brief
A Phase 2 clinical trial evaluating Potassium nitrate and sodium fluoride and Standard fluoride dentifrice for Dentin Sensitivity. Completed, enrolled 191 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride
Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP