Efficacy of Two Chlorhexidine Solutions 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 chlorhexidine and alcohol and another one containing clorhexidine with no alcohol 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. 35 volunteers will stop mechanical supragingival 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 a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention 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 Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation

Conditions
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Dental Plaque

Intervention / Treatment
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* Drug: 0.12% Clorhexidine with alcohol
* Drug: placebo
* Drug: 0.12% Clorhexidine without alcohol


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
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: 0.12% Clorhexidine with alcohol<br>0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days | Drug: 0.12% Clorhexidine with alcohol<br>* Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days<br>* Other names: No plak;Drug: placebo<br>* Use of placebo every 12 hours for 04 days<br>Drug: 0.12% Clorhexidine without alcohol<br>* Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days<br>* Other names: Periogard;|
| Experimental: 0.12% Clorhexidine without alcohol<br>0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days | Drug: 0.12% Clorhexidine with alcohol<br>* Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days<br>* Other names: No plak;Drug: placebo<br>* Use of placebo every 12 hours for 04 days<br>Drug: 0.12% Clorhexidine without alcohol<br>* Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days<br>* Other names: Periogard;|
| Placebo Comparator: control<br>placebo 15ml every 12 hour for 4 days | Drug: 0.12% Clorhexidine with alcohol<br>* Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days<br>* Other names: No plak;Drug: placebo<br>* Use of placebo every 12 hours for 04 days<br>Drug: 0.12% Clorhexidine without alcohol<br>* Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days<br>* Other names: Periogard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index. | 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). | 24hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biofilms, cross over trial, chlorhexidine