Conditions: Dentinal Hypersensitivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 140
Healthy volunteers: yes

Brief summary:
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

Detailed description:
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design 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, four and eight weeks to monitor clinical efficacy and safety.

Arms:
arm 1: Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate arm 2: Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate arm 3: Dentifrice containing 1000 ppmF as sodium monofluorophosphate arm 4: Dentifrice containing 1100 ppmF as sodium fluoride

Interventions: intervention 1: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice intervention 2: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice intervention 3: Sodium monofluorophosphate dentifrice intervention 4: Sodium Fluoride dentifrice
Intervention descriptions: intervention 1: Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate intervention 2: No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate intervention 3: Sodium monofluorophospate dentifrice (1000 ppm F) intervention 4: Dentifrice containing 1100ppm F as sodium fluoride

Protocol document: