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

NCT02479711 | Unknown DMC

• 1 other identifier: Dep of Pedodontics, Ege
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries

Keywords

glass ionomer; bulk fill composite

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

composite restoration

EXPERIMENTAL

lower permanent molar with an approximal and /or occlusal carious lesion will be restored with Tetric EvoCeram Bulk Fill composite

Other: composite restoration

glass ionomer cement

ACTIVE COMPARATOR

lower permanent molar with an approximal and /or occlusal carious lesion will be restored with the glass ionomer restoration, Equia

Other: glass ionomer cement

Interventions

composite restoration OTHER

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.

Also known as: Tetric EvoCeram Bulk fill composite

composite restoration

glass ionomer cement OTHER

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.

Also known as: a high viscosity glass ionomer cement, Equia

glass ionomer cement

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients who has occlusal carious lesions in their mandibular molar teeth

You may not qualify if:

• Patients with extremely poor oral hygiene, severe or chronic periodontitis, or heavy bruxism habits were excluded from the study

Sponsors & Collaborators

• Ege University: lead

Related Publications (5)

• 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.

  PMID: 17082278 BACKGROUND

• Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.

  PMID: 6935165 BACKGROUND

• 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.

  PMID: 24561041 BACKGROUND

• 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.

  PMID: 24268044 BACKGROUND

• 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.

  PMID: 25299703 BACKGROUND

MeSH Terms

Interventions

Glass Ionomer Cements; EQUIA composite

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nazan Ersin

  Ege University

  STUDY DIRECTOR

• Fahinur Ertugrul

  Ege University

  STUDY CHAIR

• Arzu Aykut- Yetkiner

  Ege University

  PRINCIPAL INVESTIGATOR

• İlhan Uzel

  Ege University

  PRINCIPAL INVESTIGATOR

• Elif Atila

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assisstant

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: June 24, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 26, 2015

Record last verified: 2015-08