Conditions: Dentin Sensitivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 191
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: 3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride arm 2: Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)

Interventions: intervention 1: Potassium nitrate and sodium fluoride intervention 2: Standard fluoride dentifrice
Intervention descriptions: intervention 1: 3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride intervention 2: Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP

Protocol document: