Overview

This trial is active, not recruiting.

Condition caries
Treatments composite restoration, glass ionomer cement
Sponsor Ege University
Start date January 2014
End date March 2016
Trial size 35 participants
Trial identifier NCT02479711, Dep of Pedodontics, Ege

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
lower permanent molar with an approximal and /or occlusal carious lesion will be restored with Tetric EvoCeram Bulk Fill composite
composite restoration Tetric EvoCeram Bulk fill composite
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.
(Active Comparator)
lower permanent molar with an approximal and /or occlusal carious lesion will be restored with the glass ionomer restoration, Equia
glass ionomer cement a high viscosity glass ionomer cement
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.

Primary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Ege University.