Compare the Clinical Efficacy of Prototype Toothpastes

Study Overview
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Brief Summary
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Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.

Official Title
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Compare the Clinical Efficacy of Prototype Toothpastes

Conditions
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Dental Plaque

Intervention / Treatment
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* Drug: Fluoride
* Drug: Triclosan, fluoride
* Other: Metal salt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers 18-65 years of age. Good general health. Must sign informed consent form. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present. No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. Exclusion Criteria: Subject unable or unwilling to sign the informed consent form. Medical condition which requires pre-medication prior to dental visits/procedures. Moderate or advanced periodontal disease. 5 or more decayed untreated dental sites at screening. Other disease of the hard or soft oral tissues. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation). Use of medications that currently affect salivary flow. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. Pregnant or nursing women. Participation in any other clinical study within 1 week prior to enrollment into this study. Use of tobacco products. Subjects who must receive dental treatment during the study dates. Current use of Antibiotics for any purpose. Presence of an orthodontic appliance. History of allergy to common dentifrice ingredients. History of allergy to zinc. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride control -A<br>Winterfresh Gel | Drug: Fluoride<br>* Brush twice daily<br>* Other names: Colgate Winterfresh Gel;|
| Active Comparator: Triclosan/Fluoride - B<br>Positive control (Total toothpaste) | Drug: Triclosan, fluoride<br>* Brush twice daily<br>* Other names: Colgate Total toothpaste;|
| Experimental: Triclosan/fluoride/metal salt- C<br>test toothpaste | Other: Metal salt<br>* Brush twice daily<br>* Other names: New toothpaste formula being evaluated.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Plaque Index score 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 weeks | 
| Gingivitis Index | Gingivitis score- 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 Weeks |