Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
1 other identifier
interventional
26
1 country
1
Brief Summary
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2018
CompletedFirst Submitted
Initial submission to the registry
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
February 16, 2023
CompletedFebruary 16, 2023
April 1, 2019
2 years
July 24, 2019
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
during patient visit over the 9 weeks
Study Arms (2)
Stannous fluoride test toothpaste
EXPERIMENTALCurrently marketed as the new Colgate Total SF containing Stannous Fluoride
Colgate flouride toothpaste
PLACEBO COMPARATORColgate Dental Cream containing Stannous Sodium Fluoride
Interventions
0.454% stannous fluoride toothpaste
0.76 % Sodium MonoFluorophosphate (MFP)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Toronto
Toronto, Ontario, M5S, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Glogauer, DDS/PhD
University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2019
First Posted
February 16, 2023
Study Start
December 22, 2018
Primary Completion
December 22, 2020
Study Completion
December 22, 2020
Last Updated
February 16, 2023
Record last verified: 2019-04