Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation

Study Overview
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Brief Summary
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The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).

Detailed Description
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This is a double blind, cross over, randomized clinical trial. 28 volunteers will stop mechanical supragingiva biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for one minute with a slurry of either a triclosan containing dentifice or a control without triclosan. Every 24h the presence of deposits will be registered with special atention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.

Official Title
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Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation

Conditions
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Dental Plaque

Intervention / Treatment
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* Other: Test - Using of a suspension containing Triclosan
* Other: Control - Using of a suspension without Triclosan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age from 18 years; non-smokers; have good general health; present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis. Exclusion Criteria: positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation; positive history of allergies at using Triclosan; pregnant or lactating patients; patients in use of fixed orthodontic appliance.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Using of a suspension containing Triclosan | Other: Test - Using of a suspension containing Triclosan<br>* The participants should have used only the suspension containing Triclosan during 5 days and have stopped with their biofilm control homemade procedures.<br>|
| Placebo Comparator: Control<br>Using of a suspension without Triclosan or other active ingredient | Other: Control - Using of a suspension without Triclosan<br>* The participants should have used only the Placebo suspension during 5 days and have stopped with their biofilm control homemade procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Plaque Free Zone | The presence of scores 0, 1 or 2 of the index Plaque Free Zone will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days). | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crossover, Biofilm, Triclosan, Clinical trial