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NCT05731778 Clinical Trial

Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Gingivitis Clinical Trial

Official title:
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05731778
Other study ID # CRO-2018-07-IND-GING-DELAY-JG
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 22, 2018
Est. completion date December 22, 2020

Study information
Verified date April 2019
Source Colgate Palmolive
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date December 22, 2020
Est. primary completion date December 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Stannous Fluoride Toothpaste
0.454% stannous fluoride toothpaste
• Colgate fluoride toothpaste
0.76 % Sodium MonoFluorophosphate (MFP)

Locations
Country Name City State
Canada University of Toronto Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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