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.

NCT07276672 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2025-07-STN-OW2-DR-BGS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Hydrogen Peroxide

Outcome Measures

Primary Outcomes (1)

• Mod. Lobene Stain Index

  each tooth will be scored separately using a 4 point area and intensity scale

  one day

Study Arms (2)

Test 1 toothpaste

EXPERIMENTAL

2%HPToothpaste

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

Test 2 toothpaste

ACTIVE COMPARATOR

.76% Na MFP toothpaste

Drug: Colgate Great Regular Flavor Toothpaste

Interventions

Colgate Great Regular Flavor Toothpaste DRUG

0.76% Na MFP

Test 2 toothpaste

Optic White Adv Sparkling White (2%HP) Toothpaste DRUG

0.243% NaF toothpaste

Test 1 toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Spa Dental

Santo Domingo, 10148, Dominican Republic

Location

MeSH Terms

Interventions

Toothpastes

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 11, 2025
• Study Start: November 20, 2025
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)