NCT06378008

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DRUG	CSPS toothpaste	Toothpaste containing 5.0% weight/weight (w/w) CSPS.
DRUG	Regular fluoride toothpaste (Crest Cavity Protection)	Regular fluoride toothpaste containing 1100 parts per million (ppm) fluoride.

Timeline

• Start date: 2024-04-16
• Primary completion: 2024-09-04
• Completion: 2024-09-04
• First posted: 2024-04-22
• Last updated: 2025-09-08
• Results posted: 2025-09-08

Locations

1 site across 1 country: Canada