A Study to Evaluate Sampling Methods for Subgingival Plaque

NCT02841839 | Completed

• 1 other identifier: 2016135
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To identify a sampling method for collecting subgingival plaque

Conditions

Subgingival Plaque

Outcome Measures

Primary Outcomes (1)

• Subgingival plaque

  subgingival plaque quantity measured by periopaper or curette sampling

  4 weeks

Study Arms (1)

2-step system

EXPERIMENTAL

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

Drug: Stannous Fluoride

Interventions

Stannous Fluoride DRUG

2-step system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

MeSH Terms

Interventions

Tin Fluorides

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 22, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 15, 2023

Record last verified: 2023-11