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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

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

Brief 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 Summary: 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.
Sponsor: HALEON

Current Primary Outcome: Tooth color of the facial surfaces of the six anterior maxillary teeth will be assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER.
It uses a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest).
The shade level of each tooth surface will be scored visually by the clinical examiner with reference to the Bleachedguide, where lower score indicates improvement.

Original Primary Outcome: Tooth color of the facial surfaces of the six anterior maxillary teeth will be assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER.
It uses a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest).
The shade level of each tooth surface will be scored visually by the clinical examiner with reference to the Bleachedguide, where lower score indicates improvement.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: HALEON

Dates:
Date Received: November 21, 2023
Date Started: November 27, 2023
Date Completion: November 27, 2023
Last Updated: December 19, 2023
Last Verified: December 01, 2023