A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste

Study Overview
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Brief Summary
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The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.

Detailed Description
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The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.

Official Title
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Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method

Conditions
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Dental Plaque

Intervention / Treatment
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* Other: Negative Control (Regular Toothpaste)
* Other: Positive Control (anti-plaque/anti-bacterial toothpaste)
* Drug: Prototype (AN0128 Toothpaste)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between ages 18 to 65 years inclusive Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present Must give written informed consent Be in good general health Must discontinue oral hygiene for 24-hours after initial appointment No known 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 visits/procedures Advanced periodontal disease 5 or more decayed, untreated dental sites Diseases of the soft or hard oral tissues Orthodontic appliances Abnormal salivary function Use of drugs that can affect salivary flow Use of antibiotics one (1) month prior to or during this study Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff Pregnant or breastfeeding Participation in another clinical study in the month preceding this study Allergic to common dentifrice ingredients Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) History of allergic reaction to any anti-inflammatory agents

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: Prevention
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Negative Control<br>Regular Toothpaste | Other: Negative Control (Regular Toothpaste)<br>* Regular Toothpaste<br>|
| Active Comparator: Positive Control<br>Standard anti-plaque and anti-bacterial toothpaste. | Other: Positive Control (anti-plaque/anti-bacterial toothpaste)<br>* Standard anti-plaque and anti-bacterial toothpaste<br>|
| Active Comparator: Prototype<br>AN0128 Toothpaste | Drug: Prototype (AN0128 Toothpaste)<br>* AN0128 Toothpaste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing) |  | Baseline (time zero), 24 hour time point | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Plaque