Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

Federal University of Pelotas30 enrolled

Overview

This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion. The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.

The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin. A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-carious Cervical Lesions

Interventions

Sodium hypochloritePROCEDURE

Application of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system.

WaterPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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.

Locations (1)

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Change from baseline in Retention rates of the restoration

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

Time frame: 6, 12, 24, 36 and 60 months

Secondary Outcomes

Change from baseline in Post-operative sensitivity

At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.

Time frame: 6, 12, 24, 36 and 60 months

Change from baseline in marginal staining rates

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).

Time frame: 6, 12, 24, 36 and 60 months

Data from ClinicalTrials.gov

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