A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System Versus Bulk Filled Resin-based Composite
This trial is active, not recruiting.
|Treatments||composite restoration, glass ionomer cement|
|Start date||January 2014|
|End date||March 2016|
|Trial size||35 participants|
|Trial identifier||NCT02479711, Dep of Pedodontics, Ege|
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.
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Wear of bulk filled resin-based composite versus high viscosity glass ionomer cement
time frame: 2 years
Clinical performance of bulk filled resin-based composite versus high viscosity glass ionomer cement
time frame: 2 years
Male or female participants from 8 years up to 12 years old.
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
|Official title||A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System|
|Principal investigator||Arzu Aykut- Yetkiner|
|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.|
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