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A Study to Evaluate Sampling Methods for Subgingival Plaque

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841839
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
To identify a sampling method for collecting subgingival plaque

Condition or disease Intervention/treatment Phase
Subgingival Plaque Drug: Stannous Fluoride Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque
Study Start Date : June 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2-step system
Subjects are to brush with 2-step system for 4 weeks; stannous fluoride
Drug: Stannous Fluoride



Primary Outcome Measures :
  1. Subgingival plaque [ Time Frame: 4 weeks ]
    subgingival plaque quantity measured by periopaper or curette sampling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02841839    
Other Study ID Numbers: 2016135
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fluorides
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs