Stannous Fluoride and Gingivitis

A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Stannous fluoride

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Group; Subjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste	Drug: Stannous fluoride; brush twice daily with stannous fluoride toothpaste for 8 weeks
Active Comparator: Unhealthy Group; Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste	Drug: Stannous fluoride; brush twice daily with stannous fluoride toothpaste for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides
• Other Study ID Numbers: 2022001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No