Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

NCT ID: NCT05731778

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-22

Study Completion Date

2020-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stannous fluoride test toothpaste

Currently marketed as the new Colgate Total SF containing Stannous Fluoride

Group Type EXPERIMENTAL

Stannous Fluoride Toothpaste

Intervention Type DRUG

0.454% stannous fluoride toothpaste

Colgate flouride toothpaste

Colgate Dental Cream containing Stannous Sodium Fluoride

Group Type PLACEBO_COMPARATOR

Colgate fluoride toothpaste

Intervention Type DRUG

0.76 % Sodium MonoFluorophosphate (MFP)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stannous Fluoride Toothpaste

0.454% stannous fluoride toothpaste

Intervention Type DRUG

Colgate fluoride toothpaste

0.76 % Sodium MonoFluorophosphate (MFP)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Colgate Total SF Colgate Dental Cream

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Glogauer, DDS/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRO-2018-07-IND-GING-DELAY-JG

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Bleeding-Model Clinical Study
NCT05916508 COMPLETED NA