Clinical Performance of Restorative Materials in Primary Teeth

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Caries; Dentin, Dental Caries

Intervention / Treatment
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* Device: Compomer
* Device: RMGIC
* Device: Giomer
* Device: Amalgam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Compomer<br>Adhesive agent+Compomer | Device: RMGIC<br>* 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.<br>Device: Giomer<br>* Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.<br>Device: Amalgam<br>* Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.<br>|
| Other: RMGIC<br>Primer+RMGIC | Device: Compomer<br>* 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.<br>Device: Giomer<br>* Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.<br>Device: Amalgam<br>* Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.<br>|
| Other: Giomer<br>Adhesive Agent+ Giomer | Device: Compomer<br>* 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.<br>Device: RMGIC<br>* 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.<br>Device: Amalgam<br>* Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.<br>|
| Other: Amalgam<br>Amalgam | Device: Compomer<br>* 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.<br>Device: RMGIC<br>* 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.<br>Device: Giomer<br>* Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.<br>|

What is the study measuring?
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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 | Long-term clinical success of different restorative materials in class II cavities on primary molar teeth | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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restorative materials, primary teeth, children