NCT06150573

A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching

A Randomized, Controlled, Single-Blind Clinical Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to investigate the ability of an experimental dentifrice containing 5 percent (%) potassium nitrate (KNO3), 1% alumina and 5% sodium tripolyphosphate (STP), to maintain tooth color and reduce extrinsic dental stain accumulation following peroxide tooth bleaching compared to a regular fluoride dentifrice.

Detailed description

This will be a randomized, single-blind, single-center, controlled, two arm, stratified (clinically diagnosed dentine hypersensitivity \[DH\] \[Yes/No\]), parallel group study to evaluate the efficacy of an experimental dentifrice containing 5% KNO3, 1% alumina and 5% STP, to maintain tooth color and reduce the accumulation of extrinsic tooth stain following peroxide tooth bleaching compared to a regular fluoride-containing dentifrice. The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 160 participants to study treatment to ensure approximately 128 evaluable participants complete the study.

Conditions

• Dentin Sensitivity
• Oral Hygiene

Interventions

Type	Name	Description
DRUG	Test Dentifrice	Dentifrice containing 5% weight by weight (w/w) KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride.
DRUG	Reference Dentifrice (Aquafresh Cavity Protection)	Dentifrice containing 1150 ppm fluoride as sodium fluoride.

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2023-11-29
• Last updated: 2025-07-24
• Results posted: 2025-07-24

Locations

1 site across 1 country: United States