A Study to Evaluate Sampling Methods for Subgingival Plaque

Procter & Gamble (P&G)

Status

Completed

Conditions

Subgingival Plaque

Treatments

Drug: Stannous Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

2016135

Details and patient eligibility

About

To identify a sampling method for collecting subgingival plaque

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.