Stannous Fluoride and Gingivitis

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Drug: Stannous fluoride

• Registration Number: NCT05326373
• Lead Sponsor: Procter and Gamble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-06
• Study Start: 2022-04-11
• Study First Posted: 2022-04-13
• Status Verified: 2022-06
• Primary Completion: 2022-06-13
• Study Completion: 2022-06-13
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unhealthy Group	Stannous fluoride	Subjects with gingivitis (\>/= bleeding 20 sites) will use stannous fluoride toothpaste
Healthy Group	Stannous fluoride	Subjects without gingivitis (\</= 3 bleeding sites) will use stannous fluoride toothpaste

Primary Outcome Measures

Name	Time	Method
MGI	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	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)

Trial Locations

Locations (1)

Salus Research; 🇺🇸 Fort Wayne, Indiana, United States