CP_Total: Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (SnHW and CPH) as compared to Regular Fluoride Toothpaste on the reduction of established dental plaque and gingivitis in adults.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Fluoride Control Colgate Cavity Protection 0.76% as Na MFP Toothpaste |
Drug: Colgate Cavity Protection toothpaste
0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
Other Names:
|
| Active Comparator: Colgate Total SF Colgate Total Clean Mint White Paste 1100 ppm F Toothpaste |
Drug: Colgate Total SF
1100 ppm F Colgate Total Clean Mint White Paste Toothpaste is a test treatment
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Gingivitis Scores [Baseline]
Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
- Gingivitis Scores [3 months]
Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
- Dental Plaque Score [Baseline]
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
- Dental Plaque Score [3 months]
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects, ages 18-70, inclusive. Availability for the six-month duration ofthe clinical research study. Good general health. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.
Exclusion Criteria:
Presence of partial denture. Presence of partial removable dentures. Tumor(s) of the soft or hard tissues of the oral cavity. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment. Antibiotic use any time during the one month 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 which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse. Pregnant or lactating subjects.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Consumer Research Consulting, LLC | Melbourne | Florida | United States | 32940 |
Sponsors and Collaborators
- Colgate Palmolive
Investigators
- Study Director: Yun Po Zhang, Doctoral, Colgate Palmolive
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRO-2019-03-PG-SNF-FL-BGS