Gingivitis
Conditions
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.
Interventions
DRUGStannous fluoride
brush twice daily with stannous fluoride toothpaste for 8 weeks
Sponsors
Procter and Gamble
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed