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.

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

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.

Study Overview

• Status: Completed
• Conditions: Whitening
• Intervention / Treatment: Drug: Optic White Adv Sparkling White (2%HP) Toothpaste; Drug: Colgate Great Regular Flavor Toothpaste

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic, 10148
    • Spa Dental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 toothpaste; 2%HPToothpaste	Drug: Optic White Adv Sparkling White (2%HP) Toothpaste; 0.243% NaF toothpaste
Active Comparator: Test 2 toothpaste; .76% Na MFP toothpaste	Drug: Colgate Great Regular Flavor Toothpaste; 0.76% Na MFP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mod. Lobene Stain Index	each tooth will be scored separately using a 4 point area and intensity scale	one day

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Actual): November 24, 2025
• Study Completion (Actual): November 24, 2025

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hydrogen Peroxide
• Additional Relevant MeSH Terms: Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dentifrices; Toothpastes
• Other Study ID Numbers: CRO-2025-07-STN-OW2-DR-BGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes