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OpenTrials
Completed

NCT Number: NCT02841839

A Study to Evaluate Sampling Methods for Subgingival Plaque

To identify a sampling method for collecting subgingival plaque

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stannous Fluoride

Drug

Primary outcomes

  1. Subgingival plaque

    Time frame: 4 weeks

    subgingival plaque quantity measured by periopaper or curette sampling

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2016
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.