Efficacy of a Toothpaste Containing Hydrogen Peroxide as Compared to a Regular Fluoride Toothpaste Without Hydrogen Peroxide in the Immediate Removal of Tooth Stains After a Single Brushing.

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Whitening

Treatments

Drug: Optic White Adv Sparkling White (2%HP) Toothpaste

Drug: Colgate Great Regular Flavor Toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT07276672

CRO-2025-07-STN-OW2-DR-BGS

Details and patient eligibility

About

The aim of this study is to evaluate and compare the immediate efficacy of a hydrogen peroxide-containing toothpaste versus a regular fluoride toothpaste without hydrogen peroxide in removing extrinsic tooth stains following a single supervised brushing in healthy adult participants.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed Informed Consent Form;
Male and female subjects, aged 18-70, inclusive;
Good general health and good oral health based on the opinion of the study investigator; - Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
A minimum composite mean of ≥ 1.5 determined by the Mod. Lobene Tooth Stain Index;
Available for the duration of the study;
Clinical evidence of a tendency to form extrinsic stains on anterior teeth

Exclusion criteria

Presence of orthodontic appliances/retainers involving scorable teeth;
Presence of partial removable/fixed dentures and/or restorations involving scorable teeth; 3. Tumor(s) of the soft or hard tissues of the oral cavity;
Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
Five or more carious lesions requiring immediate care;
Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
Concurrent participation in another clinical study;
Self-reported pregnancy and/or lactating women;
Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study
History of allergies or sensitivity to tooth whitening products, hydrogen peroxide, personal care consumer products, or their ingredients;
History of alcohol and/or drug abuse.