Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

Study Overview
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Brief Summary
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The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not been evaluated especially because most studies utilized a previous disruption of biofilms in all dental surfaces before the beginning of rinsing. The purpose of this study is to compare staining and calculus formation after 0.12 percent chlorhexidine between previously plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.

Detailed Description
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Test panel The test panel will be recruited from the dental students of the Lutheran University of Brazil, Canoas, Rio Grande do Sul, Brazil. At recruitment, subjects will be asked about their medical and dental history. Written and oral explanations detailing the study purpose and design will be given for each subject. Subjects that preliminarily met inclusion/exclusion criteria will be selected for a dental screening appointment. If the subject met all the inclusion/exclusion criteria, an informed consent was handed out and, upon acceptance, signed by the volunteers. The following clinical parameters were assessed in the order listed below from all teeth, excepting the third higher/lower molar. Presence of calculus (C) in all teeth, at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) was scored as a dichotomous index: 0 - Absence of calculus; 1 - Presence of calculus. Discoloration Index proposed by Lobene 36 and modified by Macpherson et al. 2000. This involves visual stain assessment of the buccal/labial and lingual/palatal aspects of the index teeth.

Official Title
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Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.

Conditions
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Dental Calculus, Tooth Discoloration

Intervention / Treatment
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* Other: Dental prophylaxis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-35 years Male No relevant medical conditions that could interfere on the periodontal health Probing pocket depth < 3 mm and clinical attachment loss < 2mm at all sites Willingness to comply Exclusion Criteria: Antibiotic and/or anti-inflammatory therapy within 3 months prior to baseline examination Oral mucosal lesions Smokers Need for antibiotic premedication History of hypersensitivity to chlorhexidine Any device that could act as plaque retentive factor (e.g., carious lesions, inadequate restorations, dental implants, orthodontic appliances, fixed or removable prostheses) Exclusion criteria during the study: Individuals that wanted to give up the study Any acute process like allergic reaction to the product or gingival abcess Necessity to use of any antibiotic or anti-inflammatory Use of any other rinsing product farther the chlorhexidine's rinses Individuals who did any mechanical biofilm control

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Dental prophylaxis|Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Staining |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental calculus formation |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, adverse effects, staining, dental calculus, dental plaque