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
Overview
- Phase
- Phase 3
- Intervention
- Test
- Conditions
- Gingivitis
- Sponsor
- Colgate Palmolive
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Whole-Mouth Gingivitis Measurement
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Group I
toothpaste brushing 2x daily morning \& evening for 2 minutes
Intervention: Test
Group I
toothpaste brushing 2x daily morning \& evening for 2 minutes
Intervention: Control
Group II
toothpaste brushing 2x daily morning \& evening for 2 minutes
Intervention: Test
Group II
toothpaste brushing 2x daily morning \& evening for 2 minutes
Intervention: Control
Outcomes
Primary Outcomes
Whole-Mouth Gingivitis Measurement
Time Frame: baseline, 3 months and 6 months
difference of reduction in gingival index
Whole-Mouth Dental Plaque Measurement
Time Frame: baseline, 3 months and 6 months
difference of reduction in plaque index