Brief Title: a Clinical Study to Assess Gingivitis

October 23, 2024 updated by: Procter and Gamble

A Three-Month Bleeding Model Clinical Study

The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

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

No

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 10-70 % 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
Sham Comparator: 0.76% Sodium Monofluorophosphate
Drug: 0.76% Sodium Monofluorophosphate Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Active Comparator: 0.454% Stannous Fluoride
Drug: 0.454% Stannous Fluoride Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Experimental: 0.454% Stannous Fluoride, 4.7 pH
Drug: 0.454% Stannous Fluoride Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Experimental: 0.454% Stannous Fluoride, 5.8 pH
Drug: 0.454% Stannous Fluoride Dentifrice
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Bleeding Sites
Time Frame: 3 months, 1 month
Number of bleeding sites derived from the Löe-Silness Gingivitis Evaluation based on a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
3 months, 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Löe-Silness Gingivitis Evaluation
Time Frame: 3 months, 1 month
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).
3 months, 1 month

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)

March 7, 2022

Primary Completion (Actual)

June 6, 2022

Study Completion (Actual)

June 6, 2022

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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