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.

NCT ID: NCT07276672

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2025-11-24

Brief Summary

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.

Conditions

Whitening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test 1 toothpaste

2%HPToothpaste

Group Type: EXPERIMENTAL

Optic White Adv Sparkling White (2%HP) Toothpaste

Intervention Type: DRUG

0.243% NaF toothpaste

Test 2 toothpaste

.76% Na MFP toothpaste

Group Type: ACTIVE_COMPARATOR

Colgate Great Regular Flavor Toothpaste

Intervention Type: DRUG

0.76% Na MFP

Interventions

Optic White Adv Sparkling White (2%HP) Toothpaste

0.243% NaF toothpaste

Intervention Type: DRUG

Colgate Great Regular Flavor Toothpaste

0.76% Na MFP

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Spa Dental

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id