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

Not Applicable

Completed

• Conditions: Primary Teeth
• Interventions: 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)

• Registration Number: NCT04678141
• Lead Sponsor: Suleyman Demirel University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-07-23
• Primary Completion: 2018-10-23
• Study Completion: 2020-08-23
• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-16
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

* Mentally and physically healthy

Exclusion Criteria

* Systemic disease or medical complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Composite and compomer materials	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)	Children aged 5-6 years with at least two carious proximal surface primary molars

Primary Outcome Measures

Name	Time	Method
USPHS criteria	up to 2 years	Clinical evaluation of composite resin and compomer restorations in primary molars

Trial Locations

Locations (1)

Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department; 🇹🇷 Isparta, Turkey