Clinical Evaluation of Compomer and Composite Class II Restorations in Primary Molars: 24 Months Results

Study Overview
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Brief Summary
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It was aimed to evaluate the clinical performance of resin-hybrid composite and compomer materials in primary molars over a 2-year period.

Detailed Description
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All treatment stages were performed by the same experienced pediatric dentist (E.O.) to avoid behavioral problems. When necessary, topical anesthesia with 2% Xylocaine® DENTAL was administered, followed by local anesthesia with epinephrine 1: 100.000 (lidocaine HCl and Epinephrine Injection, DENTSPLY Pharmaceutical, USA). Access to proximal surfaces was provided with high-speed diamond bur (FD.D.801, Frank Dental, Germany) under an air-water coolant. The proximal cavity was opened at the occlusal level. Soft carious dentine was removed with a round low-speed steel bur (SS.1A, Frank Dental, Germany). Restorations were placed under isolation with cotton rolls and a saliva ejector. The Ca(OH)2 cavity liner material (Hydrocal LC, Medicept Dental, India) was used as base material if the distance from the pulp was not safe. A metal matrix band (Matrix band, Hahnenkratt, Königsbach-Stein, Germany) was applied to the tooth with a universal matrix system (Tofflemire, Hahnenkratt, Königsbach-Stein, Germany) and wooden wedges (TDV, No 1). ClearfilTM SE Bond (Kuraray Medical Inc, Okayama, Japan) was applied to the cavity according to the manufacturer's instructions. For the polymerization, an LED curing light (Eliapar Freelight, 3M ESPE Dental Products, America) was used with a light power density of 600 mW/cm2. According to the manufacturer's instructions, A2 composite resin (Kerr Herculite Classic) and two different compomer materials (Dyract/XP and R&D Series NOVA) were applied to the teeth with the incremental technique, and each increment was light-polymerized for 20 sec with an LED curing light.

Official Title
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Clinical Evaluation of Compomer and Composite Class II Restorations in Primary Molars: 24 Months Results

Conditions
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Primary Teeth

Intervention / Treatment
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* Other: Dyract XP (Dentsply De Trey), Kerr Herculite Classic (Kerr Corporation),R&D Series NOVA(Kuraray Medical Inc) Clearfil TM SE Bond (Kuraray Medical),Hydrocal LC (Medicept Dental)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: * Mentally and physically healthy Exclusion Criteria: * Systemic disease or medical complications

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Composite and compomer materials<br>Children aged 5-6 years with at least two carious proximal surface primary molars | Other: Dyract XP (Dentsply De Trey), Kerr Herculite Classic (Kerr Corporation),R&D Series NOVA(Kuraray Medical Inc) Clearfil TM SE Bond (Kuraray Medical),Hydrocal LC (Medicept Dental)<br>* compomer (Dyract XP,R&D Series NOVA) , composite (Kerr Herculite Classic),Bonding (Clearfil TM SE Bond), Dycall (Hydrocal LC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| USPHS criteria | Clinical evaluation of composite resin and compomer restorations in primary molars | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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class II, compomer, composite resin, primary molars, restoration