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OpenTrials
Completed

NCT Number: NCT06565897

Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.

Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1, 3, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Consumer Research Consulting, LLC

Melbourne, Florida, 32940, United States

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 years, inclusive.
  • Availability for the six-week duration of the clinical research study.
  • Good general health based on the opinion of the study investigator
  • Minimum of 20 permanent natural teeth (excluding third molars).
  • Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
  • Initial mean plaque index of at least 0.6 as determined by Navy Plaque index.

Exclusion criteria

  • Presence of orthodontic appliances.
  • Presence of partial removable dentures.
  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
  • Five or more carious lesions requiring immediate restorative treatment.
  • Antibiotic use any time during the one-month period prior to entry into the study.
  • Participation in any other clinical study or test panel within the one month prior to entry into the study.
  • Dental prophylaxis during the past two weeks prior to baseline examinations.
  • History of allergies to oral care/personal care consumer products or their ingredients.
  • On any prescription medicines that might interfere with the study outcome.
  • An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
  • History of alcohol and/or drug abuse.
  • Self-reported pregnancy and/or lactating subjects.

Treatment and study plan

Test Regimen

Drug

toothpaste & manual toothbrush

Control Regimen

Drug

toothpaste & manual toothbrush

Primary outcomes

  1. Plaque assessment

    Time frame: Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks

    The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. Refinement of the Navy plaque index to increase plaque scoring efficiency in gum line and interproximal tooth areas.

  2. Gingivitis Assessment

    Time frame: Initial reading, 1-week, 3-weeks, and 6-weeks

    A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Established Plaque and Gingivitis: a 6-week Clinical Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Mar 18, 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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