Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01947192|
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : February 24, 2016
This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations.
A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% CRX for 60 seconds after the acid etching procedure). Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture instructions, by previously trained operators. The restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World Dental Federation (FDI) criteria. The outcome is retention of the restoration.
|Condition or disease||Intervention/treatment||Phase|
|Non-carious Cervical Lesions||Procedure: Treatment with chlorhexidine Procedure: Water pre-treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2012|
Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching
Procedure: Treatment with chlorhexidine
Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.
Placebo Comparator: Water
Application of water (placebo) after dentin acid etching.
Procedure: Water pre-treatment
Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application
- Change from baseline in Retention rates of the restoration at 24 months [ Time Frame: 6, 12 and 24 months ]Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention
- Change from baseline in Post-operative sensitivity at 6-month [ Time Frame: baseline and 6-month ]At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.
- Change from baseline in marginal staining rates at 6. 12 and 24 months [ Time Frame: 6, 12 and 24 months ]At each time-point, patients will be recalled and restorations will be reassessed in order to record changes in the rates of marginal staining, using the World Dental Federation (FDI) criteria for restorations assessment (Hickel et al 2010).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947192
|School of Dentistry, Federal University of Pelotas|
|Pelotas, RS, Brazil, 96015-560|
|Principal Investigator:||Maximiliano Cenci, PhD||School of Dentistry-UFPel|