Efficacy of Manual Toothbrushes in Removing Tooth Stains

Last updated: September 23, 2024
Sponsor: Colgate Palmolive
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

NaF

Na MFP

Clinical Study ID

NCT06486974
CRO-2024-08-STN-DRW-DR-BGS
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.

Eligibility Criteria

Inclusion

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 studyinvestigator;

  • Presence of permanent natural anterior teeth (no veneers/crowns/restorations thatmay interfere with this study scoring procedures);

  • A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;

  • Available for the duration of the study;

  • Clinical evidence of a tendency to form extrinsic stains on anterior teeth.

Exclusion

Exclusion Criteria:

  • Presence of orthodontic appliances/retainers involving scorable teeth;

  • Presence of partial removable/fixed dentures and/or restorations involving scorableteeth;

  • Tumor(s) of the soft or hard tissues of the oral cavity;

  • Obvious signs of periodontal disease rampant caries, or any condition that thedental 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 thatmight 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 dentalprophylaxis (professional dental cleaning) within thirty (30) days - prior to thestart of the study;

  • History of allergies to oral care/personal care consumer products or theiringredients;

  • History of alcohol and/or drug abuse.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: NaF
Phase: 3
Study Start date:
September 23, 2024
Estimated Completion Date:
October 31, 2024

Study Description

The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.

Connect with a study center

  • Spa Dental

    Santo Domingo,
    Dominican Republic

    Active - Recruiting

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