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Completed

NCT Number: NCT05916521

A Three Month Bleeding-Model Clinical Study

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be at least 18 years of age;
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
  • Have at least 20 gradable teeth;
  • Have established gingivitis with 10-70% bleeding sites;
  • Agree to return for scheduled visits and follow the study procedures;
  • Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
  • Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion criteria

  • Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
  • Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
  • Having known hypersensitivity to the test products;
  • Having removable oral appliances;
  • Having fixed facial or lingual orthodontic appliances;
  • Self-reported pregnancy or lactation;
  • Having any diseases or condition that might interfere with the safe participation in the study;
  • Having an inability to undergo study procedures.

Treatment and study plan

0.454% stannous fluoride

Drug

Brush two times daily

0.76% sodium monofluorophosphate

Drug

Brush two times daily

0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

Drug

Brush two times daily

Primary outcomes

  1. Löe-Silness Gingivitis Evaluation

    Time frame: Baseline

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

  2. Löe-Silness Gingivitis Evaluation

    Time frame: Week 4

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

  3. Löe-Silness Gingivitis Evaluation

    Time frame: Week 12

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Three-Month Bleeding-Model Clinical Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2023
Registry last updated
Jun 23, 2023

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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