A Study to Evaluate Sampling Methods for Subgingival Plaque

Not Applicable

Completed

• Conditions: Subgingival Plaque
• Interventions: Drug: Stannous Fluoride

• Registration Number: NCT02841839
• Lead Sponsor: Procter and Gamble

Brief Summary

To identify a sampling method for collecting subgingival plaque

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2-step system	Stannous Fluoride	Subjects are to brush with 2-step system for 4 weeks; stannous fluoride

Primary Outcome Measures

Name	Time	Method
Subgingival plaque	4 weeks	subgingival plaque quantity measured by periopaper or curette sampling