Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

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.

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Detailed Description

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Conditions

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Non-carious Cervical Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Chlorhexidine

Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching

Group Type EXPERIMENTAL

Treatment with chlorhexidine

Intervention Type PROCEDURE

Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.

Water

Application of water (placebo) after dentin acid etching.

Group Type PLACEBO_COMPARATOR

Water pre-treatment

Intervention Type PROCEDURE

Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Interventions

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Treatment with chlorhexidine

Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.

Intervention Type PROCEDURE

Water pre-treatment

Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes