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NCT Number: NCT03037814

Clinical Performance of Restorative Materials in Primary Teeth

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

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compomer

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

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

Device

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

Amalgam

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.

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Beste Ozgur, DDS, PhD

CONTACT

[email protected]

005072657769

Zafer C Cehreli, DDS, PhD

CONTACT

[email protected]

00905353197969

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jan 31, 2017
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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