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Completed

NCT Number: NCT05326373

Stannous Fluoride and Gingivitis

8-week study using stannous fluoride toothpaste on subjects with gingivitis ("unhealthy") and without gingivitis ("healthy"). Gingivitis index will be performed at BL, Week 4 and Week 8. A number of biological samples will be collected at each timepoint.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salus Research

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be 18 years of age or older;
  • Provide written informed consent and receive a signed copy of consent;
  • Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
  • Agree not to participate in any other oral care studies for the duration of this study;
  • Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
  • Agree to return for all scheduled visits and follow study procedures;
  • Have at least 16 natural teeth;
  • Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

For Unhealthy Group:

  • Have at least 20 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
  • Have a minimum of 3 sampling sites with bleeding and pocket depth >/=3mm but not deeper than 4mm at the Screening visit.

For Healthy Group:

  • Have a maximum of 3 bleeding sites (sites with a score of 1 or 2 on the Screening GBI exam); and
  • No pockets deeper than 2mm.

Exclusion criteria

  • Self-reported pregnancy or the intent to become pregnant anytime during the course of the study;
  • Inability to comply with study procedures;
  • Rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
  • Severe periodontal disease, including but not limited to purulent exudate, generalized mobility, and/or severe recession;
  • Fixed orthodontic appliances or attachments for aligner treatment;
  • Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
  • Having taken antibiotics or used anti-gingivitis/anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
  • Needing an antibiotic prophylaxis prior to dental visits;
  • Presenting with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
  • Having any condition or disease, as determined by the Investigator/Designee which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Treatment and study plan

Stannous Fluoride

Drug

brush twice daily with stannous fluoride toothpaste for 8 weeks

Primary outcomes

  1. MGI

    Time frame: 8 weeks

    Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).

  2. GBI

    Time frame: 8 weeks

    Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding)

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2022
Registry last updated
Jun 16, 2022

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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