Evaluating Commercial Anti-Plaque Products and Oral Rinse

Study Overview
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Brief Summary
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Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Detailed Description
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This clinical research study was to train new examiners for short term plaque clinical methodologies.

Official Title
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Evaluating Commercial Anti-Plaque Products and Oral Rinse

Conditions
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Dental Plaque

Intervention / Treatment
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* Drug: Fluoride
* Drug: Chlorhexidine digluconate
* Drug: Fluoride, triclosan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers at least 18 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). 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 are currently affect salivary function. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. Allergy to chlorhexidine. 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 pre-medication for dental treatment or for any other purpose. Presence of an orthodontic appliance that interferes with plaque scoring. 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: 23 Years
Maximum Age: 81 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>Negative control | Drug: Fluoride<br>* Half mouth toothbrushing twice a day for four days.<br>* Other names: fluoride toothpaste;|
| Active Comparator: Triclosan/Fluoride toothpaste<br>positive control toothpaste | Drug: Fluoride, triclosan<br>* Half mouth Brushing twice daily<br>* Other names: Total toothpaste;|
| Active Comparator: Chlorhexidine Oral Rinse<br>Positive Control mouthrinse | Drug: Chlorhexidine digluconate<br>* Mouth rinsing with 15 ml for 30 seconds twice a day for four days.<br>* Other names: Periogard oral rinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Plaque 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) | Four days |