Staining and Calculus Formation After 0.12% Chlorhexidine Rinses

This study has been completed.

Sponsor:

Information provided by:

Lutheran University of Brazil

ClinicalTrials.gov Identifier:

NCT00818376

First received: January 6, 2009

Last updated: January 29, 2009

Last verified: January 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	January 6, 2009
Last Updated Date	January 29, 2009
Start Date ^ICMJE	June 2006
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 29, 2009)	Dental Staining [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: January 6, 2009)	Dental Staining [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00818376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 29, 2009)	Dental calculus formation [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 6, 2009)	Dental calculus formation [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
Official Title ^ICMJE	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 Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Dental Calculus Tooth Discoloration
Intervention ^ICMJE	Other: Dental prophylaxis Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
Study Arm (s)	Not Provided
Publications *	Zanatta FB, Antoniazzi RP, Rösing CK. Staining and calculus formation after 0.12% chlorhexidine rinses in plaque-free and plaque covered surfaces: a randomized trial. J Appl Oral Sci. 2010 Sep-Oct;18(5):515-21.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	December 2008
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 35 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00818376
Other Study ID Numbers ^ICMJE	LutheranUB
Has Data Monitoring Committee	Yes
Responsible Party	Cassiano Kuchenbecker Rösing, Lutheran University Center
Study Sponsor ^ICMJE	Lutheran University of Brazil
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Lutheran University of Brazil
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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