The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.

Detailed Description
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This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste. Qualified subjects will be enrolled and randomized to either one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three and six months of product use. All subjects will be followed for adverse events throughout the study.

Official Title
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The Clinical Investigation of a New Toothpaste Containing SnF as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in China

Conditions
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Dental Plaque, Gingivitis

Intervention / Treatment
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* Drug: MFP Fluoride toothpaste
* Drug: Stannous fluoride toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, ages 18-70, inclusive. Availability for the six-month duration of the 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 orthodontic bands. 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 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 or drinking for periods up to 4 hours. History of alcohol or drug abuse. Self-reported pregnant or lactating subjects.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Tooth brushing study. Subjects brush their whole mouth 2x/day for 1 minute each time. The study duration is 6 months
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: MFP Fluoride toothpaste<br>Commercially available, monofluorophosphate (MFP) toothpaste. Fluoride level is 0.76% | Drug: MFP Fluoride toothpaste<br>* Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,<br>* Other names: Colgate Great Regular Flavor toothpaste;|
| Experimental: Stannous Fluoride Toothpaste<br>New toothpaste containing 0.454% stannous fluoride. | Drug: Stannous fluoride toothpaste<br>* Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Scores | 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) | Baseline | 
| Dental Plaque Scores | 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) | 3 month | 
| Dental Plaque Scores | 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) | 6 month | 
| Gingivitis Scores | 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) | Baseline | 
| Gingivitis Scores | 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) | 3 months | 
| Gingivitis Scores | 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) | 6 months |