Stannous Fluoride and Gingivitis

Gingivitis Clinical Trial

Official title:

A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326373
• Other study ID #: 2022001
• Status: Completed
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: June 13, 2022

Study information

• Verified date: June 2022
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Stannous fluoride
brush twice daily with stannous fluoride toothpaste for 8 weeks

Locations

Country	Name	City	State
United States	Salus Research	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MGI	Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).	8 weeks
Primary	GBI	Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding)	8 weeks