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Clinical Performance of Restorative Materials in Primary Teeth

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ClinicalTrials.gov Identifier: NCT03037814
Recruitment Status : Not yet recruiting
First Posted : January 31, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Zafer Cavit Cehreli, Hacettepe University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Caries; Dentin Dental Caries Device: Compomer Device: RMGIC Device: Giomer Device: Amalgam Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth
Estimated Study Start Date : March 28, 2019
Estimated Primary Completion Date : July 25, 2023
Estimated Study Completion Date : March 25, 2024

Arm Intervention/treatment
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.

RMGIC
Primer+RMGIC
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.

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.

Giomer
Adhesive Agent+ Giomer
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.

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.

Amalgam
Amalgam
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.

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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037814


Contacts
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Contact: Zafer C Cehreli, DDS, PhD 00905353197969 zcehreli@gmail.com
Contact: Beste Ozgur, DDS, PhD 005072657769 besteisbitiren@yahoo.com

Locations
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Turkey
Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Zafer C Cehreli, DDS, PhD Hacettepe University

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 26161601
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 19953810
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 12542617

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Responsible Party: Zafer Cavit Cehreli, Prof, Hacettepe University
ClinicalTrials.gov Identifier: NCT03037814     History of Changes
Other Study ID Numbers: HUDHF-3-primary teeth
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zafer Cavit Cehreli, Hacettepe University:
restorative materials
primary teeth
children

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases