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.
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 6, 2009
CompletedFirst Posted
Study publicly available on registry
January 7, 2009
CompletedJanuary 30, 2009
January 1, 2009
5 months
January 6, 2009
January 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dental Staining
21 days
Secondary Outcomes (1)
Dental calculus formation
21 days
Interventions
Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 21085810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 6, 2009
First Posted
January 7, 2009
Study Start
June 1, 2006
Primary Completion
November 1, 2006
Study Completion
December 1, 2008
Last Updated
January 30, 2009
Record last verified: 2009-01