Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-29 @ 8:59 AM
Study NCT ID:
NCT01075256
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Response of a Tubule Occlusion Agent
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
An Exploratory Clinical Study to Evaluate the Efficacy of Two Currently Marketed Toothpastes Containing Different Concentrations of a Tubule Occlusion Agent
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: