Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
Primary Purpose
Dental Calculus, Tooth Discoloration
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dental prophylaxis
Sponsored by
About this trial
This is an interventional prevention trial for Dental Calculus focused on measuring Chlorhexidine, adverse effects, staining, dental calculus, dental plaque
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Dental Staining
Secondary Outcome Measures
Dental calculus formation
Full Information
NCT ID
NCT00818376
First Posted
January 6, 2009
Last Updated
January 29, 2009
Sponsor
Lutheran University of Brazil
1. Study Identification
Unique Protocol Identification Number
NCT00818376
Brief Title
Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
Official Title
Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lutheran University of Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Calculus, Tooth Discoloration
Keywords
Chlorhexidine, adverse effects, staining, dental calculus, dental plaque
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Dental prophylaxis
Intervention Description
Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
Primary Outcome Measure Information:
Title
Dental Staining
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Dental calculus formation
Time Frame
21 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
21085810
Citation
Zanatta FB, Antoniazzi RP, Rosing 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. doi: 10.1590/s1678-77572010000500015.
Results Reference
derived
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Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
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