Caries Clinical Trial
Official title:
A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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