Clinical trial NCT05326373: Stannous Fluoride and Gingivitis
Official title: A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2022-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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.

Primary outcomes:
measure: MGI
timeFrame: 8 weeks
measure: GBI
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
References: