A Pilot Study to Evaluate a Molecular Method for Plaque

A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity

This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control.

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.