Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

Not Applicable

Completed

• Conditions: Non-carious Cervical Lesions

• Registration Number: NCT01947192
• Lead Sponsor: Federal University of Pelotas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-11
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Retention rates of the restoration at 24 months	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Post-operative sensitivity at 6-month	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	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).

Trial Locations

Locations (1)

School of Dentistry, Federal University of Pelotas; 🇧🇷 Pelotas, RS, Brazil