Clinical Study to Compare Dental Plaque Control

Study Overview
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Brief Summary
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This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Detailed Description
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Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

Official Title
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Clinical Study to Compare Dental Plaque Control

Conditions
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Dental Plaque

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers at least 18 - 53 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). 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 are currently affecting salivary function 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 which interferes with plaque scoring. History of allergy to common dentifrice ingredients. History of allergy to arginine (amino acid) History of allergy to bicarbonate Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 53 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride - A<br>Fluoride only toothpaste | Drug: Fluoride<br>* Brush two times a day for 4 days.<br>* Other names: monofluorophosphate;|
| Active Comparator: Total + Whitening toothpaste - B<br>Triclosan/fluoride toothpaste | Drug: Triclosan/Fluoride<br>* Brush two times daily for 4 days<br>* Other names: triclosan;|
| Experimental: Triclosan/fluoride/Amino Acid - C<br>toothpaste containing amino acid #1 | Drug: Triclosan/Fluoride<br>* Brush twice daily for 4 days<br>* Other names: amino acid;|
| Experimental: Triclosan/fluoride/Cavistat -D<br>toothpaste containing amino acid/bicarbonate | Drug: Triclosan/Fluoride<br>* Brush twice daily for 4 days<br>* Other names: amino acid/bicarbonate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Index | plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque. | 4-Day |