A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System Versus Bulk Filled Resin-based Composite

Not Applicable

• Conditions: Caries
• Interventions: Other: glass ionomer cement; Other: composite restoration

• Registration Number: NCT02479711
• Lead Sponsor: Ege University

Brief Summary

The aim of the present study is to evaluate the clinical performance of EQUİA restoration material in Class II cavities comparing with a resin-based composite / dentin bonding system.

Detailed Description

35 patients at 12-year-old, who have a matched pair of permanent molars with an approximal and /or occlusal carious lesion of similar size will be included.

split -mouth design for the two restorative materials will be used. After removing the carious each patient will receive two restorations following the taking impressions to determine the cavity size.

One of the two materials will be Equia (GC Europe N.V., Leuven , Belgium), a high viscosity glass ionomer cement and the second material used will be Tetric EvoCeram Bulk Fill composite (IvoClar Vivadent), along with a dentin bonding system (AdheSe One F, Ivoclar Vivadent, Lichtenstein).

The dentist will randomly select the restorative material to be placed. The dentist will mix and handle the materials, in accordance with the manufacturers' instructions.

The clinician will use a matrix to maintain tight adaptation of the restorations.

The clinician will take impressions after the first setting reactions of the materials are done to determine the wear of the restorative materials.

Two blinded examiners who were not involved in the placement of the restorations will evaluate the restorations at six, 12 and 24 months.

Impressions will be repeated at 12 and 24 months intervals. The examiners will use the U.S Public Health Service (USPHS) Ryge criteria to evaluate the restorations.

Wear analysis will be performed with a 3 dimensional laser scanning device (Laserscan 3D, Willytec, Germany) by scanning the cast models.

The data will be analyzed using statistical software (SPSS 13.0, SPSS, Chicago). Cumulative survival rates will be estimated using the Kaplan-Meier method and long-rank-test.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26
• Primary Completion: 2016-03
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients who has occlusal carious lesions in their mandibular molar teeth

Exclusion Criteria

• Patients with extremely poor oral hygiene, severe or chronic periodontitis, or heavy bruxism habits were excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glass ionomer cement	glass ionomer cement	lower permanent molar with an approximal and /or occlusal carious lesion will be restored with the glass ionomer restoration, Equia
composite restoration	composite restoration	lower permanent molar with an approximal and /or occlusal carious lesion will be restored with Tetric EvoCeram Bulk Fill composite

Primary Outcome Measures

Name	Time	Method
Wear of bulk filled resin-based composite versus high viscosity glass ionomer cement	2 years	using with a 3 dimensional laser scanning device by scanning cast models
Clinical performance of bulk filled resin-based composite versus high viscosity glass ionomer cement	2 years	in accordance with Ryge criteria