Subgingival Plaque
Conditions
Brief summary
To identify a sampling method for collecting subgingival plaque
Interventions
DRUGStannous Fluoride
Sponsors
Procter and Gamble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 use the acclimation toothpaste together with their regular brush and refrain from any other oral care products (including floss and mouth rinse) between the Screening and Baseline Visit; * Agree to use the treatment products and 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, mouth rinse, 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 10-20 bleeding sites; and * Have minimum 6 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.
Exclusion criteria
* 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; * Taking allergy medication or any other medication that can affect salivary flow such as an antihistamine; * Need an antibiotic prophylaxis prior to dental visits; * A history of hypersensitivity to oral care products containing hydrogen peroxide or stannous fluoride; * A history of hypersensitivity to products containing sodium lauryl sulfate (SLS); * Are pregnant (Self-reported) or lactating; or * Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, 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 |
|---|---|---|
| Subgingival plaque | 4 weeks | subgingival plaque quantity measured by periopaper or curette sampling |
Outcome results
None listed