Back to resultsClinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Stannous Fluoride Toothpaste
Colgate fluoride toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
Inclusion Criteria: Male or female volunteers aged 18-70 years In good general health, ASA I No clinical signs of gingival inflammation at >90% sites observed Probing Depth (PD) < 3.0 mm Attachment Loss (AL) = 0 mm No periodontal disease history Non-smokers Fluent in English Exclusion Criteria: Presence of orthodontic bands. Presence of partial removal dentures. Tumour(s) of the soft or the hard tissues of the oral cavity. Cavitated carious lesions requiring immediate restorative treatment. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study. Participation in any other clinical study or test panel with a one month period prior to entering the study.
Sites / Locations
- University of Toronto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Stannous fluoride test toothpaste
Colgate flouride toothpaste
Arm Description
Currently marketed as the new Colgate Total SF containing Stannous Fluoride
Colgate Dental Cream containing Stannous Sodium Fluoride
Outcomes
Primary Outcome Measures
Bleeding Index (BOP) and Oral Inflammatory Load
BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05731778
Brief Title
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
Official Title
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 22, 2018 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stannous fluoride test toothpaste
Arm Type
Experimental
Arm Description
Currently marketed as the new Colgate Total SF containing Stannous Fluoride
Arm Title
Colgate flouride toothpaste
Arm Type
Placebo Comparator
Arm Description
Colgate Dental Cream containing Stannous Sodium Fluoride
Intervention Type
Drug
Intervention Name(s)
Stannous Fluoride Toothpaste
Other Intervention Name(s)
Colgate Total SF
Intervention Description
0.454% stannous fluoride toothpaste
Intervention Type
Drug
Intervention Name(s)
Colgate fluoride toothpaste
Other Intervention Name(s)
Colgate Dental Cream
Intervention Description
0.76 % Sodium MonoFluorophosphate (MFP)
Primary Outcome Measure Information:
Title
Bleeding Index (BOP) and Oral Inflammatory Load
Description
BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses
Time Frame
during patient visit over the 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female volunteers aged 18-70 years
In good general health, ASA I
No clinical signs of gingival inflammation at >90% sites observed
Probing Depth (PD) < 3.0 mm
Attachment Loss (AL) = 0 mm
No periodontal disease history
Non-smokers
Fluent in English
Exclusion Criteria:
Presence of orthodontic bands.
Presence of partial removal dentures.
Tumour(s) of the soft or the hard tissues of the oral cavity.
Cavitated carious lesions requiring immediate restorative treatment.
History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
Participation in any other clinical study or test panel with a one month period prior to entering the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Glogauer, DDS/PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
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