A Pilot Study to Evaluate a Molecular Method for Plaque

Procter & Gamble (P&G)

Status

Completed

Conditions

Plaque

Gingivitis

Treatments

Drug: cavity protection toothpaste

Drug: stannous fluoride toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

2015049

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.