Chlorhexidine Mouthrinses and Plaque Control

Study Overview
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Brief Summary
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The aim of the present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F).

Detailed Description
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Chlorhexidine (CLX) mouthrinse has been the gold standard as antiplaque solution.However, if its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%, the formulation of the final product may affect the effectiveness. Thus, it can be concluded from this study that 0.12% CLX alcohol base mouthrinse is significantly more effective in inhibiting plaque than the diluted 0.1% CLX non-alcohol base containing formaldehyde mouthrinse.

Official Title
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Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials

Conditions
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Dental Plaque

Intervention / Treatment
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* Drug: Synthodont
* Drug: Soludent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give written informed consent before entering the study accept to stop tooth cleaning for a week Exclusion Criteria: less than 20 teeth; presence of periodontal disease presence of factors of plaque retention (clinically unacceptable restorations, important carious, dental overlapping, removable prosthesis, faulty fixed prosthesis, orthodontic appliances), associated systemic diseases (diabetes, heart disorders, blood diseases, HIV infection), use of antibiotics or other anti-inflammatory drugs during the latest months, known allergy against components of mouth rinses, pregnancy, smoking

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 25 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine alcohol-base mouthrinse<br> | Drug: Synthodont<br>* 15 ml, tree times/day for 07 days Arm: Chlorhexidine alcohol-base mouthrinse<br>|
| Experimental: non alcohol chlorhexidine mouthrinse<br> | Drug: Soludent<br>* 15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days Arm: Experimental: non alcohol chlorhexidine mouthrinse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index (PI)at Day 1 and Day 7. | The clinical trial lasted 7 days (from Day 0 to Day 7). During this period all participants abstained from all mechanical oral hygiene procedures. On Day 0, subjects were randomly distributed in three groups: two test groups and one negative control group, and were instructed to rinse twice daily with the allocated mouthrinse during the experimental period. The clinical measurement: Plaque Index (PI) was recorded on Day 1 and Day 7. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities. | at day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine mouthrinse, Plaque control