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Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Sponsor
Colgate Palmolive (Industry)
Overall Status
Completed
CT.gov ID
NCT05731778
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

Condition or Disease Intervention/Treatment Phase
  • Drug: Stannous Fluoride Toothpaste
  • Drug: Colgate fluoride toothpaste
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
Actual Study Start Date :
Dec 22, 2018
Actual Primary Completion Date :
Dec 22, 2020
Actual Study Completion Date :
Dec 22, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bleeding Index (BOP) and Oral Inflammatory Load [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Toronto Toronto Ontario Canada M5S

    Sponsors and Collaborators

    • Colgate Palmolive

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Colgate Palmolive
    ClinicalTrials.gov Identifier:
    NCT05731778
    Other Study ID Numbers:
    • CRO-2018-07-IND-GING-DELAY-JG
    First Posted:
    Feb 16, 2023
    Last Update Posted:
    Feb 16, 2023
    Last Verified:
    Apr 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gingivitis
    Listerine
    Fluorides
    Sodium Fluoride
    Tin Fluorides

    Study Results

    No Results Posted as of Feb 16, 2023