Clinical Performance of Restorative Materials in Primary Teeth

March 12, 2021 updated by: Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth

The purpose of this study is to evaluate and compare the clinical performance of dental restorative materials in Class II cavities of primary molar teeth

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Restorations will be placed on four primary molar teeth with proximal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.

Group 1: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

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

4 years to 7 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients and parent of the patients who accept to participate and sign the informed consent
  • Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
  • Teeth that have healthy lamina dura and periodontal ligament
  • Teeth that have caries lesions extending no more than the outher half of dentin radiographically

Exclusion Criteria:

  • Patients and parent of the patients who don't accept to participate and sign the informed consent
  • Teeth that are previously restored
  • Patients who are uncooperative
  • Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
  • Patients who have bruxism, skeletal or dental malocclusion
  • Teeth that have developmental defects or anomalies

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Compomer
Adhesive agent+Compomer
Device: RMGIC
Dental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins.
Device: Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
Device: Amalgam
Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
OTHER: RMGIC
Primer+RMGIC
Device: Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
Device: Amalgam
Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
Device: Compomer
Aesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements.
OTHER: Giomer
Adhesive Agent+ Giomer
Device: RMGIC
Dental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins.
Device: Amalgam
Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
Device: Compomer
Aesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements.
OTHER: Amalgam
Device: RMGIC
Dental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins.
Device: Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
Device: Compomer
Aesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
Time Frame: 5 years
Long-term clinical success of different restorative materials in class II cavities on primary molar teeth
5 years

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Zafer C Cehreli, DDS, PhD, Hacettepe University

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 (ANTICIPATED)

September 28, 2021

Primary Completion (ANTICIPATED)

July 25, 2026

Study Completion (ANTICIPATED)

March 25, 2027

Study Registration Dates

First Submitted

January 29, 2017

First Submitted That Met QC Criteria

January 29, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUDHF-3-primary teeth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 26161601
  2. Clinical Study Report
    Information identifier: 19953810
  3. Clinical Study Report
    Information identifier: 12542617

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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