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

NCT02717520 | Unknown DMC

• 1 other identifier: 05-PA-26-7/2015
• Study Type: interventional
• Target: 180
• Locations: 4 countries
• Sites: 4

Brief 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

Keywords

glass hybrid; composite

Outcome Measures

Primary Outcomes (4)

• Evaluating surface and marginal staining of the materials

  Criteria established by Hickel et al. (2007) will be used

  5 year

• Evaluating fracture and retention of the materials

  Criteria established by Hickel et al. (2007) will be used

  5 year

• Evaluating marginal adaptation and discoloration of the materials

  Criteria established by Hickel et al. (2007) will be used

  5 years

• Evaluating wear of the materials

  Criteria established by Hickel et al. (2007) will be used

  5 years

Secondary Outcomes (1)

• Evaluating suitability of direct impression scanning vs. replica model scanning for wear assessment

  5 years

Study Arms (1)

All study participants

EXPERIMENTAL

One permanent molar with an approximal and occlusal carious lesion restored with EQUIA Forte, and one permanent molar with an approximal and occlusal carious lesion restored with Tetric EvoCeram

Device: EQUIA Forte and Tetric EvoCeram

Interventions

EQUIA Forte and Tetric EvoCeram DEVICE

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.

All study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with indication for restorative treatment on vital teeth in posterior molar region
• Restorations limited to two surfaces with one proximal cavity in occlusion
• Favourable and stable occlusal relationship between the remaining teeth.

You may not qualify if:

• Subject with full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment
• Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year
• Pulp exposure
• Allergy to any ingredient of a material
• Severe bruxing

Sponsors & Collaborators

• University of Zagreb: lead
• University of Milan: collaborator
• University of Belgrade: collaborator
• Ege University: collaborator

Study Sites (4)

School of Dental Medicine

Zagreb, Croatia

Location

Dental School

Milan, Italy

Location

Faculty of Dental Medicine

Belgrade, Serbia

Location

Ege University

Izmir, Turkey (Türkiye)

Location

Related Publications (2)

• Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.

  PMID: 18341239 BACKGROUND

• Schwendicke F, Rossi JG, Krois J, Basso M, Peric T, Turkun LS, Miletic I. Cost-effectiveness of glass hybrid versus composite in a multi-country randomized trial. J Dent. 2021 Apr;107:103614. doi: 10.1016/j.jdent.2021.103614. Epub 2021 Feb 19.

  PMID: 33617942 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 23, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

CR (1); SE (1); TU (1); IT (1)