Clinical Trial: Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.
Brief Summary: 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 Summary:
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.
Sponsor: Lutheran University of Brazil
Current Primary Outcome: Dental Staining [ Time Frame: 21 days ]
Original Primary Outcome: Dental Staining
Current Secondary Outcome: Dental calculus formation [ Time Frame: 21 days ]
Original Secondary Outcome: Dental calculus formation
Information By: Lutheran University of Brazil
Dates:
Date Received: January 6, 2009
Date Started: June 2006
Date Completion:
Last Updated: January 29, 2009
Last Verified: January 2009
