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A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers

Dentin Sensitivity Clinical Trial

Official title:
An 8-Week, Randomized, Controlled, Examiner-Blind, Clinical Study to Evaluate the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentin Hypersensitivity in a Population of Dentin Hypersensitivity Sufferers

Clinical Trial Summary

The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste.

Clinical Trial Description

This will be a single center, 8-week, randomized, controlled, examiner-blind, 2-treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected 'test teeth') clinical study to evaluate the anti-sensitivity efficacy of a 5% CSPS toothpaste in a DH population. The clinical efficacy of the 5% CSPS toothpaste (test toothpaste) will be compared with that of a reference toothpaste, a commercially available, regular fluoride toothpaste with no known anti-sensitivity properties (negative control). Sufficient participants will be screened to randomize approximately 234 participants to investigational product (approximately 117 per treatment group) and to ensure approximately 210 evaluable participants complete the entire study (approximately 105 per treatment group). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06378008
Study type Interventional
Source HALEON
Contact Haleon Response Center
Phone +441932 95 95 00
Email ww.clinical-trial-register@haleon.com
Status Recruiting
Phase N/A
Start date April 16, 2024
Completion date September 13, 2024
View Details
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