NCT05459558

Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Toothpastes Compared to a Standard Toothpaste When Used Twice Daily for 8 Weeks

A Randomized, Controlled, Single-Blind Clinical Study to Investigate the Tooth Stain Removal Efficacy of Two Experimental Potassium Nitrate Dentifrices in Subjects With Extrinsic Dental Stain Compared to a Standard Dentifrice Control When Used Twice Daily for 8 Weeks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the stain removal efficacy of 2 experimental anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A daily use, regular fluoride dentifrice will be included as a reference dentifrice.

Detailed description

This will be a single-center, 8-week, randomized, controlled, single-blind, three treatment-arm, parallel design, stratified clinical study in healthy volunteers with a propensity to form dental stain. It has been designed to investigate changes in tooth stain and color, following twice-daily use of two experimental dentifrices, after four and eight weeks twice daily use; a regular fluoride dentifrice will be included as reference dentifrice. Sufficient participants will be screened to randomize approximately 300 participants to study treatment to ensure approximately 270 participants complete the study.

Conditions

• Oral Hygiene

Interventions

Type	Name	Description
DRUG	Experimental Dentifrice 1	5 percent (%) potassium nitrate (KNO3) dentifrice with 1% alumina and 5% sodium tripolyphosphate (STP).
DRUG	Experimental Dentifrice 2	5% KNO3 dentifrice with 1% alumina, 5% STP and 2% high cleaning silica.
DRUG	Reference Dentifrice	Regular Fluoride Dentifrice.

Timeline

• Start date: 2022-09-15
• Primary completion: 2022-12-04
• Completion: 2022-12-04
• First posted: 2022-07-15
• Last updated: 2024-04-12
• Results posted: 2024-04-12

Locations

1 site across 1 country: United States