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Completed

NCT Number: NCT06486974

Efficacy of Manual Toothbrushes in Removing Tooth Stains

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Spa Dental

Santo Domingo, Dominican Republic

About this study

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.

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 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;
  • 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 to oral care/personal care consumer products or their ingredients;
  • History of alcohol and/or drug abuse.

Treatment and study plan

NaF

Drug

Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Na MFP

Drug

Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

Primary outcomes

  1. Lobene Tooth Stain Index

    Time frame: Baseline, and 6-weeks

    Each tooth will be scored separately using a 4 point area Stain Area (extent):

    (0) No stain detected

    • Stain covering up to one third (1/3) of the region
    • Stain covering > 1/3 to 2/3 of the region
    • Stain covering > 2/3 of the region

    Stain Intensity:

    (0) No stain

    • Light Stain - yellow to light brown or gray
    • Moderate stain - medium brown
    • Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
Mar 19, 2026

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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