A Study to Evaluate Sampling Methods for Subgingival Plaque

NCT ID: NCT02841839

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-06-30

Brief Summary

To identify a sampling method for collecting subgingival plaque

Conditions

Subgingival Plaque

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

2-step system

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

Group Type: EXPERIMENTAL

Stannous Fluoride

Intervention Type: DRUG

Interventions

Stannous Fluoride

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2016135

Identifier Type: -

Identifier Source: org_study_id