Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

Study Overview
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Brief Summary
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Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment

Official Title
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Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

Conditions
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Gingival Diseases

Intervention / Treatment
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* Drug: Fluoride
* Drug: Triclosan/Fluoride toothpaste
* Drug: Fluoride
* Drug: Fluoride
* Other: antibacterial plant extract


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. Must discontinue oral hygiene on the mornings of each appointment and between sampling periods. 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: Medical condition which requires pre-medication prior to dental procedures/visits. Medical condition which precludes eating/drinking for 12 hrs. History of allergy to common dentifrice ingredients. Subjects unable or unwilling to sign the informed consent form. Moderate or advanced periodontal disease. Two 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. Current use of antibiotics. 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 30 days 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. 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride Toothpaste<br>fluoride control | Drug: Fluoride<br>* Brush twice daily<br>|
| Active Comparator: Total/Whitening<br>positive control | Drug: Triclosan/Fluoride toothpaste<br>* Brush twice daily<br>|
| Experimental: antibacterial plant extract 1<br>Honokiol | Drug: Fluoride<br>* Brush twice daily<br>* Other names: honokiol;|
| Experimental: antibacterial plant extract 2<br>magnolol | Drug: Fluoride<br>* Brush twice daily<br>Other: antibacterial plant extract<br>* Brush twice daily<br>* Other names: Honokiol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Plaque score scale: 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) | 8 weeks |