Status:
COMPLETED
Stannous Fluoride and Gingivitis
Lead Sponsor:
Procter and Gamble
Conditions:
Gingivitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05326373
Start Date
April 11 2022
End Date
June 13 2022
Last Update
June 16 2022
Active Locations (1)
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1
Salus Research
Fort Wayne, Indiana, United States, 46825