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CompletedNCT02841839Updated Nov 15, 2023

A Study to Evaluate Sampling Methods for Subgingival Plaque

An interventional study of Stannous Fluoride in Subgingival Plaque, sponsored by Procter and Gamble. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Procter and Gamble · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To identify a sampling method for collecting subgingival plaque

02

Conditions studied

  • Subgingival Plaque
03

In context

Lead sponsor

Procter and Gamble is the lead sponsor of 80 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    2-step system

    Subjects are to brush with 2-step system for 4 weeks; stannous fluoride

    Drug: Stannous Fluoride

Interventions

  • DrugStannous Fluoride
06

What researchers measure

Primary outcomes

  1. Subgingival plaque

    subgingival plaque quantity measured by periopaper or curette sampling

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02841839
Lead sponsor
Procter and Gamble
Responsible party
Sponsor
First posted
Jul 22, 2016
Start date
Jun 2016
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Nov 15, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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