Long Term Clinical Evaluation of a Posterior Glass Hybrid System vs. Composite Resin

Summary

The primary objective of this study is to evaluate long-term clinical performance of a glass hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five years. The secondary objective is to evaluate the suitability of intraoral impressions for the assessment of wear of teeth and restorative materials over five years. For that purpose the replica method and scanning 3-D laser equipment and matching software will be used.

The first null hypothesis is that there would be no difference in clinical performance between restorative materials after five years. The second null hypothesis is that wear between the restorative materials will be the same after five years.

This is a multicentre, controlled clinical study conducted in Croatia, Italy, Turkey and Serbia. Eligible participants are all adults aged 18 or over with indication of restorative treatment on vital teeth in posterior molar region, limited to two surface in a healthy subjects. Exclusion criteria are presence of full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment, severe bruxing and unstable physiological or medical health, pregnancy and lactation, radiation therapy or using drugs. Each patient is receiving two restorative treatment (GIC-EQUIA Forte and composite resin material Tetric EvoCeram) each of which will be localized on molar teeth on either side of the mouth. Two independent examiners will evaluate the restorations at each site one week after placement and at one, two, three, four and five years according to the FDI criteria. After, three and five years recall, impressions of both restorations is taken and the casts is analysed by a 3D laser scanner.

Conditions

• Dental Restoration

Interventions

DEVICE

EQUIA Forte and Tetric EvoCeram

GC cavity conditioner (20% polyacrylic acid) will be applied for 10 sec, rinsed and the cavity will be dried with a cotton pellet. EQUIA Forte will be prepared according to the manufacturer instructions, applied in bulk and compacted with a condenser. The self-curing restoration will be finished after hardening, approximately 2 min 30 sec after the start of the capsule mixing, using Arkansas stones under water cooling. EQUIA Forte Coat will be applied to the surfaces and light cured with D-light for 20 sec. Enamel will be etched with 37% orthophosphoric acid for 10 sec. After the acid gel removal, the cavity will be carefully dried. The adhesive (Adhese 2, Ivoclar Vivadent) will be applied and light cured with D-light (1200 mW/cm2, slow mode) for 10 sec. The composite resin will be placed with an incremental technique (2 mm layers), and light-cured with D-light (20 sec). Restorations will be finished with fine diamond and carbide burs in slow and high-speed hand-piece and polished.

Sponsors & Collaborators

• University of Milan

  collaborator OTHER

• University of Belgrade

  collaborator OTHER

• Ege University

  collaborator OTHER

• University of Zagreb

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• Croatia
• Italy
• Serbia
• Turkey (Türkiye)

Study Locations