Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

March 3, 2024 updated by: Colgate Palmolive

The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California

The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

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
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University School of Dentistry

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:

  • Potential subjects must meet all of the following criteria
  • Subjects, ages 18-70, inclusive
  • Availability for the six-month duration of the clinical research study
  • Good general health
  • Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
  • Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
  • Signed Informed Consent Form

Exclusion Criteria:

  • Presence of orthodontic appliances
  • Presence of partial removable dentures
  • Tumor(s) of the soft or hard tissues of the oral cavity
  • Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
  • Five or more carious lesions requiring immediate restorative treatment
  • Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study
  • Dental prophylaxis during the past two weeks prior to baseline examinations
  • History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome
  • An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours
  • History of alcohol and/or drug abuse
  • Self-reported pregnancy and/or lactating subjects.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
toothpaste brushing 2x daily morning & evening for 2 minutes
Drug: Test
test toothpaste containing 0.45% stannous fluoride
Drug: Control
toothpaste containing 0.76% sodium monofluorophosphate
Active Comparator: Group II
toothpaste brushing 2x daily morning & evening for 2 minutes
Drug: Test
test toothpaste containing 0.45% stannous fluoride
Drug: Control
toothpaste containing 0.76% sodium monofluorophosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole-Mouth Gingivitis Measurement
Time Frame: baseline, 3 months and 6 months
difference of reduction in gingival index
baseline, 3 months and 6 months
Whole-Mouth Dental Plaque Measurement
Time Frame: baseline, 3 months and 6 months
difference of reduction in plaque index
baseline, 3 months and 6 months

Collaborators and Investigators

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

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Yiming Li, DDS MSD PhD, Loma Linda University

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)

August 18, 2020

Primary Completion (Actual)

March 8, 2021

Study Completion (Actual)

March 8, 2021

Study Registration Dates

First Submitted

March 3, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2020-04-PGN-LLU-YPZ

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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