Stannous Fluoride and Gingivitis

Procter & Gamble (P&G)

Status

Completed

Conditions

Gingivitis

Treatments

Drug: Stannous fluoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT05326373

2022001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.