Gingivitis Clinical Trial
Official title:
The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California
Verified date | March 2024 |
Source | Colgate Palmolive |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 8, 2021 |
Est. primary completion date | March 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Potential subjects must meet all of the following criteria - Subjects, ages 18-70, inclusive - Availability for the six-month duration of the clinical research study - Good general health - Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index - Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index - Signed Informed Consent Form Exclusion Criteria: - Presence of orthodontic appliances - Presence of partial removable dentures - Tumor(s) of the soft or hard tissues of the oral cavity - Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study - Five or more carious lesions requiring immediate restorative treatment - Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study - Dental prophylaxis during the past two weeks prior to baseline examinations - History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome - An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours - History of alcohol and/or drug abuse - Self-reported pregnancy and/or lactating subjects. |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University School of Dentistry | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Colgate Palmolive |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole-Mouth Gingivitis Measurement | difference of reduction in gingival index | baseline, 3 months and 6 months | |
Primary | Whole-Mouth Dental Plaque Measurement | difference of reduction in plaque index | baseline, 3 months and 6 months |
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