Back to resultsStannous Fluoride and Gingivitis
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stannous fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
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.
Sites / Locations
- Salus Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy Group
Unhealthy Group
Arm Description
Subjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste
Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste
Outcomes
Primary Outcome Measures
MGI
Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05326373
Brief Title
Stannous Fluoride and Gingivitis
Official Title
A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Group
Arm Type
Active Comparator
Arm Description
Subjects without gingivitis (</= 3 bleeding sites) will use stannous fluoride toothpaste
Arm Title
Unhealthy Group
Arm Type
Active Comparator
Arm Description
Subjects with gingivitis (>/= bleeding 20 sites) will use stannous fluoride toothpaste
Intervention Type
Drug
Intervention Name(s)
Stannous fluoride
Intervention Description
brush twice daily with stannous fluoride toothpaste for 8 weeks
Primary Outcome Measure Information:
Title
MGI
Description
Modified Gingival Index- validated assessment of gingival health looking at inflammation based on 4-point range 0 (normal gingiva) to 4 (severe inflammation).
Time Frame
8 weeks
Title
GBI
Description
Gingival Bleeding Index- validated assessment of gingival health looking at bleeding based on 2-point range 0 (Absence of bleeding) to 2 (Immediate bleeding)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Salus Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stannous Fluoride and Gingivitis
We'll reach out to this number within 24 hrs