NCT01831817

Exploratory Study to Evaluate the Efficacy of 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: 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 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.

Conditions

• Dentinal Hypersensitivity

Interventions

Type	Name	Description
DRUG	5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice	Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate
DRUG	0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice	No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate
DRUG	Sodium monofluorophosphate dentifrice	Sodium monofluorophospate dentifrice (1000 ppm F)
DRUG	Sodium Fluoride dentifrice	Dentifrice containing 1100ppm F as sodium fluoride

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-04-15
• Last updated: 2015-03-26
• Results posted: 2015-03-26

Locations

1 site across 1 country: United States