Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

February 7, 2023 updated by: Colgate Palmolive
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S
        • University of Toronto

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female volunteers aged 18-70 years
  2. In good general health, ASA I
  3. No clinical signs of gingival inflammation at >90% sites observed
  4. Probing Depth (PD) < 3.0 mm
  5. Attachment Loss (AL) = 0 mm
  6. No periodontal disease history
  7. Non-smokers
  8. Fluent in English

Exclusion Criteria:

  1. Presence of orthodontic bands.
  2. Presence of partial removal dentures.
  3. Tumour(s) of the soft or the hard tissues of the oral cavity.
  4. Cavitated carious lesions requiring immediate restorative treatment.
  5. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
  6. Participation in any other clinical study or test panel with a one month period prior to entering the study.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stannous fluoride test toothpaste
Currently marketed as the new Colgate Total SF containing Stannous Fluoride
Drug: Stannous Fluoride Toothpaste
0.454% stannous fluoride toothpaste
Other Names:
  • Colgate Total SF
Placebo Comparator: Colgate flouride toothpaste
Colgate Dental Cream containing Stannous Sodium Fluoride
Drug: Colgate fluoride toothpaste
0.76 % Sodium MonoFluorophosphate (MFP)
Other Names:
  • Colgate Dental Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding Index (BOP) and Oral Inflammatory Load
Time Frame: during patient visit over the 9 weeks
BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses
during patient visit over the 9 weeks

Collaborators and Investigators

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

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Michael Glogauer, DDS/PhD, University of Toronto

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)

December 22, 2018

Primary Completion (Actual)

December 22, 2020

Study Completion (Actual)

December 22, 2020

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Estimate)

February 16, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2018-07-IND-GING-DELAY-JG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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