NCT07297732

A Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Effectiveness of Two Experimental Toothpastes

Exploratory Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Efficacy of Two Experimental Toothpastes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, and oral tolerability of two experimental toothpastes in a DH population with appropriate tooth shade and dental stain levels for the evaluation of whitening performance.

Detailed description

This will be a single center, randomized, controlled, examiner-blind, 3-treatment arm, stratified (Baseline mean VITA Bleached Guide 3D-MASTER score), parallel design, clinical study in healthy participants, aged 18-65 years inclusive, with sufficient tooth discoloration/surface stain to evaluate the whitening potential of the experimental formulations, and self-reported/clinically diagnosed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be randomized to one of three study toothpastes. Approximately 105 qualifying participants will be stratified and randomized to study treatment (approximately 35 participants per treatment group).

Conditions

• Dentin Hypersensitivity

Interventions

Type	Name	Description
DRUG	Test Toothpaste 1	Toothpaste containing Potassium nitrate
DRUG	Test Toothpaste 2	Toothpaste containing Potassium nitrate
DRUG	Reference Toothpaste	Regular fluoride toothpaste

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-03-19
• Completion: 2026-03-19
• First posted: 2025-12-22
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States