NCT06608368

A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching

A Randomized, Controlled Clinical Study Assessing the Effects of a Marketed Dentifrice Compared to a Regular Fluoride Dentifrice and a Positive Control Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the efficacy of a marketed dentifrice containing 5 percent (%) NovaMin (Calcium Sodium Phosphosilicate) to reduce tooth sensitivity during and post tooth bleaching compared to a marketed dentifrice containing 5% potassium nitrate (KNO3) and a marketed regular fluoride-containing dentifrice.

Detailed description

This is a randomized, examiner blind, single-center, controlled, three arm, parallel group, proof-of-principal study to evaluate tooth sensitivity during and following a course of at-home tooth bleaching in participants with and without clinically confirmed dentine hypersensitivity (DH). The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 90 participants to study treatment (approximately 30 per treatment group).

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DRUG	Test Dentifrice (Sensodyne Repair and Protect Original Mint)	Dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride.
DRUG	Positive Control Dentifrice (Sensodyne Fresh Mint)	Dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride.
DRUG	Reference Dentifrice (Crest Cavity Protection Regular)	Dentifrice containing 1100 ppm fluoride as sodium fluoride.

Timeline

• Start date: 2024-10-07
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2024-09-23
• Last updated: 2025-12-15
• Results posted: 2025-12-15

Locations

1 site across 1 country: Canada