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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Class I Dental Caries

Intervention / Treatment
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* Procedure: class I restoration placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: randomized-split mouth clinical trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glass ionomer cements, bioactive materials