Stannous Fluoride and Gingivitis

• Status: Recruiting
• Trial end date: 2022-06-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Procter and Gamble
• Treatments: Fluorides; Tin Fluorides

Criteria

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.