A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods

Procter and Gamble1 site in 1 country40 target enrollmentApril 11, 2022

ConditionsGingivitis

InterventionsStannous fluoride

DrugsStannous fluoride

Overview

Phase: Not Applicable
Intervention: Stannous fluoride
Conditions: Gingivitis
Sponsor: Procter and Gamble
Enrollment: 40
Locations: 1
Primary Endpoint: MGI
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 11, 2022

End Date

June 13, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Procter and Gamble

Responsible Party

Sponsor

Eligibility 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

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.

Arms & Interventions

Healthy Group

Subjects without gingivitis (\</= 3 bleeding sites) will use stannous fluoride toothpaste

Intervention: Stannous fluoride

Unhealthy Group

Subjects with gingivitis (\>/= bleeding 20 sites) will use stannous fluoride toothpaste

Intervention: Stannous fluoride

Outcomes

Primary Outcomes

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).

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)