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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System

Conditions
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Caries

Intervention / Treatment
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* Other: composite restoration
* Other: glass ionomer cement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: composite restoration<br>lower permanent molar with an approximal and /or occlusal carious lesion will be restored with Tetric EvoCeram Bulk Fill composite | Other: composite restoration<br>* The tooth will be isolated with cotton rolls and the caries will be removed. Enamel and dentin conditionings were performed with a self-etching adhesive system (Adhese One F, Ivoclar Vivadent, Liechtenstein). Bulk fill composite (Tetric EvoCeram® , Ivoclar Vivadent, Liechtenstein) will be injected in a single bulk increment of less than 4 mm to fill the preparations. The material was condensed with a flat instrument. Once set, it will be polished with finishing cups (Enhance® , Dentsply , Milford, USA). An interproximal strip will be used to finish the final contour.<br>* Other names: Tetric EvoCeram Bulk fill composite;|
| Active Comparator: glass ionomer cement<br>lower permanent molar with an approximal and /or occlusal carious lesion will be restored with the glass ionomer restoration, Equia | Other: glass ionomer cement<br>* The tooth will be isolated wit cotton rolls and the caries will be removed. The dentist will mix and handle the materials in accordance with the manufacturers' instructions. The material was condensed with a flat instrument. Once set, it will be polished. An interproximal strip will be used to finish the final contour. G-Coat Plus (GC, America) will be applied to the surface and margins of the restoration.<br>* Other names: Equia;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glass ionomer, bulk fill composite