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Clinical Trials/NCT04678141
NCT04678141
Completed
Not Applicable

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

Suleyman Demirel University1 site in 1 country145 target enrollmentJuly 23, 2018
ConditionsPrimary Teeth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Teeth
Sponsor
Suleyman Demirel University
Enrollment
145
Locations
1
Primary Endpoint
USPHS criteria
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 23, 2018
End Date
August 23, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Esra Oz

Assistant professor

Suleyman Demirel University

Eligibility Criteria

Inclusion Criteria

  • \* Mentally and physically healthy

Exclusion Criteria

  • \* Systemic disease or medical complications

Outcomes

Primary Outcomes

USPHS criteria

Time Frame: up to 2 years

Clinical evaluation of composite resin and compomer restorations in primary molars

Study Sites (1)

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