- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818376
Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
Staining And Calculus Formation After 0.12% Chlorhexidine Rinses In Plaque-Free And Plaque-Covered Surfaces. A Randomized Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dental Staining
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dental calculus formation
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LutheranUB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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