Evaluate Clinical Research From Commerical Oral Care Products

Study Overview
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Brief Summary
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The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

Detailed Description
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The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Official Title
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Evaluate Clinical Research From Commerical Oral Care Products

Conditions
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Gingival Diseases

Intervention / Treatment
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* Drug: Fluoride
* Drug: Triclosan/Fluoride
* Drug: Chlorhexidine Gluconate


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: Subjects 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 or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions 2 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 can 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. Allergy to chlorhexidine 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. 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: A<br> | Drug: Fluoride<br>* Brush twice daily<br>* Other names: monofluorophosphate;|
| Active Comparator: B<br> | Drug: Triclosan/Fluoride<br>* Half mouth toothbrushing twice daily for 4 days<br>* Other names: triclosan;|
| Active Comparator: C<br> | Drug: Chlorhexidine Gluconate<br>* Mouth rinsing twice a day for 4 days<br>* Other names: Chlorhexidine Gluconate oral rinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Index | Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth) | 4-Day |