Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

Study Overview
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Brief Summary
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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.

Official Title
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Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial

Conditions
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Non-carious Cervical Lesions

Intervention / Treatment
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* Procedure: Treatment with chlorhexidine
* Procedure: Water pre-treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars; Patients who had more than 20 teeth in the mouth; Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent; NCL with at least 1 mm of depth in a vital permanent incisor, canine or premolar of the upper as the lower jaw. NCL in the facial surface of the teeth with sometimes a small part extending interproximally; Patients with good periodontal heath. Exclusion Criteria: Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III); Tooth with the NCL with the absent of antagonist; NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition; Presence of caries or restorations in the area to be treated; Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing; Unwillingness to return for follow-ups or refuse to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine<br>Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching | Procedure: Treatment with chlorhexidine<br>* Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.<br>|
| Placebo Comparator: Water<br>Application of water (placebo) after dentin acid etching. | Procedure: Water pre-treatment<br>* Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Retention rates of the restoration at 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 | 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Post-operative sensitivity at 6-month | At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed. | baseline and 6-month | 
| Change from baseline in marginal staining rates at 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). | 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, Matrix metalloproteinases (MMP) inhibitor, Adhesive system, Controlled clinical trial, Dental restoration, Noncarious cervical lesions, Dental restoration failure