A Study to Evaluate Sampling Methods for Subgingival Plaque

Study Overview
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Brief Summary
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To identify a sampling method for collecting subgingival plaque

Official Title
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A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque

Conditions
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Subgingival Plaque

Intervention / Treatment
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* Drug: Stannous Fluoride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2-step system<br>Subjects are to brush with 2-step system for 4 weeks; stannous fluoride | Drug: Stannous Fluoride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subgingival plaque | subgingival plaque quantity measured by periopaper or curette sampling | 4 weeks |