NCT01075256

Dose Response of a Tubule Occlusion Agent

An Exploratory Clinical Study to Evaluate the Efficacy of Two Currently Marketed Toothpastes Containing Different Concentrations of a Tubule Occlusion Agent

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity

Detailed description

Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentine typically in response to chemical, thermal, tactile or osmotic stimuli. Dentine hypersensitivity may be treated by either making the nerve in the tooth less sensitive or by occluding the tubules to limit exposure of the nerve to external stimuli. Bioactive and biocompatible glasses react with oral fluid to deposit a mineral that is chemically analogous to that found in both enamel and dentine thus preventing exposure of the nerve to external stimuli. A number of controlled clinical trials have been reported indicating that a calcium sodium phosphosilicate bioactive glass, when incorporated into a toothpaste formulation, significantly reduce pain from dentine hypersensitivity. The aim of this study is to evaluate the effectiveness of two currently marketed toothpastes, containing 5% calcium sodium phosphosilicate and the other containing 7.5% calcium sodium phosphosilicate in the treatment of dentine hypersensitivity compared to a matched placebo control.

Conditions

• Dentine Hypersensitivity
• Dental Pain

Interventions

Type	Name	Description
DEVICE	5% calcium sodium phosphosilicate toothpaste	Low concentration calcium sodium phosphosilicate tubule occlusion agent
DEVICE	7.5% calcium sodium phosphosilicate toothpaste	High concentration calcium sodium phosphosilicate tubule occlusion agent
DEVICE	Placebo toothpaste	Placebo toothpaste

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2010-02-25
• Last updated: 2013-06-03
• Results posted: 2013-06-03

Locations

1 site across 1 country: United States