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

Not Applicable

Completed

• Conditions: Class I Dental Caries
• Interventions: Procedure: class I restoration placement

• Registration Number: NCT05559333
• Lead Sponsor: Hacettepe University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Primary Completion: 2018-02-15
• Study Completion: 2022-03-24
• Status Verified: 2022-09
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-25
• Last Update Submitted: 2022-09-25
• Study First Posted: 2022-09-29
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
zirconomer	class I restoration placement	zirconia reinforced glass ionomer cement
glass carbomer	class I restoration placement	glass ionomer cement containing nano sized- carbonized particles.
Equia Fil	class I restoration placement	High viscosity glass ionomer cement
Tetric-evo ceram bulk fill	class I restoration placement	Bulk fill composite resin

Primary Outcome Measures

Name	Time	Method
Retention Alpha for at least 90% of the restorations	24 months	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.

Secondary Outcome Measures

Name	Time	Method
marginal adaptation score alpha	24 months	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Altındağ, Turkey