NCT01691560

Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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 arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory 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.

Conditions

• Dentine Hypersensitivity

Interventions

Type	Name	Description
DRUG	5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice	Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
DRUG	0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice	Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
DRUG	Sodium monofluorophosphate dentifrice	Dentifrice containing 1000 ppmF as sodium monofluorophosphate
DRUG	Sodium fluoride dentifrice	Dentifrice containing 1100 ppmF as sodium fluoride

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-09-24
• Last updated: 2014-05-29
• Results posted: 2014-05-29

Locations

1 site across 1 country: United States