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Not yet recruiting NCT03037814

Clinical Performance of Restorative Materials in Primary Teeth

No phase Interventional Caries; Dentin Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compomer, RMGIC, Giomer, Amalgam.
Who it may be relevant to
Registry conditions: Caries; Dentin, Dental Caries. Basic parameters: 4 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria [Time frame: 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University — Ankara

Identifiers

NCT: NCT03037814 · HUDHF-3-primary teeth

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗