Clinical Performance of Restorative Materials in Primary Teeth
NCT ID: NCT03037814
Last Updated: 2021-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2021-09-28
2027-03-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Compomer
Adhesive agent+Compomer
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.
Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
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
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.
Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
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
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.
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.
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
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.
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.
Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
Interventions
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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.
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.
Giomer
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Years
7 Years
ALL
Yes
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Zafer Cavit Cehreli, DDS, PhD
Prof
Principal Investigators
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Zafer C Cehreli, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University
Locations
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Hacettepe University
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Study Documents
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Document Type: Clinical Study Report
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Clinical Study Report
View DocumentOther Identifiers
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HUDHF-3-primary teeth
Identifier Type: -
Identifier Source: org_study_id
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