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

July 16, 2022 updated by: Esra Oz, Suleyman Demirel University
It was aimed to evaluate the clinical performance of resin-hybrid composite and compomer materials in primary molars over a 2-year period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Isparta, Turkey, 32260
        • Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

* Mentally and physically healthy

Exclusion Criteria:

* Systemic disease or medical complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Composite and compomer materials
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)
compomer (Dyract XP,R&D Series NOVA) , composite (Kerr Herculite Classic),Bonding (Clearfil TM SE Bond), Dycall (Hydrocal LC)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Investigators

  • Study Director: Esra Oz, Assist Prof, Suleyman Demirel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 23, 2018

Primary Completion (ACTUAL)

October 23, 2018

Study Completion (ACTUAL)

August 23, 2020

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (ACTUAL)

December 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 16, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 72867572.050.01.04-207321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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