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OpenTrials
Completed

NCT Number: NCT07276672

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Spa Dental

Santo Domingo, 10148, Dominican Republic

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optic White Adv Sparkling White (2%HP) Toothpaste

Drug

0.243% NaF toothpaste

Colgate Great Regular Flavor Toothpaste

Drug

0.76% Na MFP

Primary outcomes

  1. Mod. Lobene Stain Index

    Time frame: one day

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

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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