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

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.

Study Overview

• Status: Unknown
• Conditions: Caries
• Intervention / Treatment: Other: composite restoration; Other: glass ionomer cement

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: composite restoration; lower permanent molar with an approximal and /or occlusal carious lesion will be restored with Tetric EvoCeram Bulk Fill composite	Other: composite restoration; 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.; Other Names: Tetric EvoCeram Bulk fill composite
Active Comparator: glass ionomer cement; lower permanent molar with an approximal and /or occlusal carious lesion will be restored with the glass ionomer restoration, Equia	Other: 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.; Other Names: a high viscosity glass ionomer cement; Equia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Director: Nazan Ersin, Ege University; Study Chair: Fahinur Ertugrul, Ege University; Principal Investigator: Arzu Aykut- Yetkiner, Ege University; Principal Investigator: İlhan Uzel, Ege University; Principal Investigator: Elif Atila, Ege University

Publications and helpful links

General Publications

• Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
• Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.
• Campos EA, Ardu S, Lefever D, Jasse FF, Bortolotto T, Krejci I. Marginal adaptation of class II cavities restored with bulk-fill composites. J Dent. 2014 May;42(5):575-81. doi: 10.1016/j.jdent.2014.02.007. Epub 2014 Feb 18.
• Alrahlah A, Silikas N, Watts DC. Post-cure depth of cure of bulk fill dental resin-composites. Dent Mater. 2014 Feb;30(2):149-54. doi: 10.1016/j.dental.2013.10.011. Epub 2013 Nov 20.
• Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: glass ionomer; bulk fill composite
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: Dep of Pedodontics, Ege