CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL

The aim of this study is to compare the clinical performances of high-viscosity glass ionomer (GI), glass carbomer (GC), zirconia-reinforced GI (ZIR), and bulk-fill (BF) composite resin restorations.For this purpose, two calibrated operators placed 128 restorations in 30 patients with a mean age of 21 years. The restorations will be evaluated by one examiner at baseline and at 6, 12, 18,24, and 48 months using the modified US Public Health Service criteria. The data will statistically analyzed.

Study Overview

• Status: Completed
• Conditions: Class I Dental Caries
• Intervention / Treatment: Procedure: class I restoration placement

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey, 06230
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients presenting 1) at least four single-surface occlusal caries on their posterior molar teeth (first and/or second molars); 2) teeth to be restored had to be vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; 3) teeth should be in occlusion; and 4) must agree to come to follow-up appointments.

Exclusion Criteria:

• patients with 1) poor oral hygiene, serious health problems, and/or heavy bruxism; 2) partly erupted teeth; 3) absence of adjacent and antagonist teeth; 4) teeth with interproximal caries; and 5) inability to attend recalls.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: zirconomer; zirconia reinforced glass ionomer cement	Procedure: class I restoration placement; zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.
Active Comparator: Equia Fil; High viscosity glass ionomer cement	Procedure: class I restoration placement; zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.
Active Comparator: glass carbomer; glass ionomer cement containing nano sized- carbonized particles.	Procedure: class I restoration placement; zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.
Active Comparator: Tetric-evo ceram bulk fill; Bulk fill composite resin	Procedure: class I restoration placement; zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention Alpha for at least 90% of the restorations	The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal adaptation score alpha	It represents the marginal integrity of the restorations. It is scored as alpha (perfect marginal adaptation), bravo (detectable marginal discrepency, clinically acceptable) or charlie (marginal crevice, clinically unacceptable). The examination of marginal adaptation is performed by clinical examination of the restoration with probe.	24 months

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: September 25, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 25, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: glass ionomer cements; bioactive materials
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: KA-17057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No