A Bleeding-Model Clinical Study

June 14, 2023 updated by: Procter and Gamble

A One-Month Bleeding-Model Clinical Study

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Silverstone Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be at least 18 years of age;
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
  • Have at least 20 gradable teeth;
  • Have established gingivitis with ≥10 % bleeding sites;
  • Agree to return for scheduled visits and follow the study procedures;
  • Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
  • Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

  • Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
  • Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
  • Having known hypersensitivity to the test products;
  • Having removable oral appliances;
  • Having fixed facial or lingual orthodontic appliances;
  • Self-reported pregnancy or lactation;
  • Having any diseases or condition that might interfere with the safe participation in the study;
  • Having an inability to undergo study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Positive Control
2 brushings per day (AM and PM)
Drug: 0.454% stannous fluoride
Brush two times daily
Sham Comparator: Negative Control
2 brushings per day (AM and PM)
Drug: 0.76% sodium monofluorophosphate
Brush two times daily
Experimental: Experimental Control
Brush with Positive control in the morning and negative control in the evening
Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
Brush two times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Löe-Silness Gingivitis Evaluation
Time Frame: Baseline
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Baseline
Löe-Silness Gingivitis Evaluation
Time Frame: Week 4
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Actual)

November 20, 2020

Study Completion (Actual)

November 20, 2020

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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