Plaque, Gingivitis
Conditions
Brief summary
This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control.
Interventions
0.454% stannous fluoride toothpaste
0.243% sodium fluoride toothpaste
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
In order to be included in the study, each subject must: * Provide written informed consent to participate in the study; * Be 18 years of age or older; * Agree not to participate in any other oral/dental product studies during the course of this study; * Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed; * Agree to maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time; * Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), 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; * Must 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; * Agree to refrain from all oral hygiene for at least 12 hours prior to each visit; * Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit; * Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index); * Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm; * Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.
Exclusion criteria
Subjects are excluded from study participation where there is evidence of: * Have had a dental prophylaxis within 2 weeks of plaque sampling visits; * Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits; * Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment; * Need an antibiotic prophylaxis prior to dental visits; * A history of hypersensitivity to oral care products containing stannous fluoride; * A history of hypersensitivity to dyes (from products containing food dyes); * Present 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 * Are pregnant (Self-reported) or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plaque scores | baseline |
Secondary
| Measure | Time frame |
|---|---|
| gingivitis score | baseline |
Countries
United States
Outcome results
None listed