Clinical trial NCT02479711: A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System Versus Bulk Filled Resin-based Composite
Official title: A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries
Keywords: glass ionomer
bulk fill composite
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 35
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wear of bulk filled resin-based composite versus high viscosity glass ionomer cement
timeFrame: 2 years
measure: Clinical performance of bulk filled resin-based composite versus high viscosity glass ionomer cement
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ege University
name: Nazan Ersin
role: STUDY_DIRECTOR
affiliation: Ege University
name: Fahinur Ertugrul
role: STUDY_CHAIR
affiliation: Ege University
name: Arzu Aykut- Yetkiner
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: İlhan Uzel
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Elif Atila
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
citation: 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.
citation: 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.
citation: 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.