Clinical Performance of Restorative Materials in Primary Teeth

NCT ID: NCT03037814

Last Updated: 2021-03-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2027-03-25

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.

Conditions

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Caries; Dentin Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Compomer

Adhesive agent+Compomer

Group Type OTHER

RMGIC

Intervention Type DEVICE

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

Intervention Type DEVICE

Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.

Amalgam

Intervention Type DEVICE

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

Group Type OTHER

Compomer

Intervention Type DEVICE

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

Intervention Type DEVICE

Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.

Amalgam

Intervention Type DEVICE

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

Group Type OTHER

Compomer

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Group Type OTHER

Compomer

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type DEVICE

Giomer

Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.

Intervention Type 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.

Intervention Type DEVICE

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Zafer Cavit Cehreli, DDS, PhD

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Zafer C Cehreli, DDS, PhD

Role: CONTACT

00905353197969

Beste Ozgur, DDS, PhD

Role: CONTACT

005072657769

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Other Identifiers

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HUDHF-3-primary teeth

Identifier Type: -

Identifier Source: org_study_id

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