A Study to Evaluate Sampling Methods for Subgingival Plaque

Subgingival Plaque Clinical Trial

Official title:

A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841839
• Other study ID #: 2016135
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: November 2023
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To identify a sampling method for collecting subgingival plaque

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Subgingival Plaque

Intervention

Drug:
• Stannous Fluoride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subgingival plaque	subgingival plaque quantity measured by periopaper or curette sampling	4 weeks