<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03037814</url>
  </required_header>
  <id_info>
    <org_study_id>HUDHF-3-primary teeth</org_study_id>
    <nct_id>NCT03037814</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Restorative Materials in Primary Teeth</brief_title>
  <official_title>Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate and compare the clinical performance of dental&#xD;
      restorative materials in Class II cavities of primary molar teeth&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Restorations will be placed on four primary molar teeth with proximal caries, in a split&#xD;
      mouth design. 100 patients will be included in the study. The teeth will be randomized into&#xD;
      four groups according to the restorative materials.&#xD;
&#xD;
      Group 1: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2:&#xD;
      Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent +&#xD;
      Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI&#xD;
      Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12.&#xD;
      months for the first year, and at every 6 months for 5 years. The modified US Public Health&#xD;
      Service criteria (secondary caries, marginal integrity, marginal discoloration and retention)&#xD;
      will be used for clinical evaluation of restorations. The data will be analysed statistically&#xD;
      using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to&#xD;
      estimate survival percentages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 28, 2021</start_date>
  <completion_date type="Anticipated">March 25, 2027</completion_date>
  <primary_completion_date type="Anticipated">July 25, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria</measure>
    <time_frame>5 years</time_frame>
    <description>Long-term clinical success of different restorative materials in class II cavities on primary molar teeth</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Caries; Dentin</condition>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Compomer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Adhesive agent+Compomer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RMGIC</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Primer+RMGIC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Giomer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Adhesive Agent+ Giomer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amalgam</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Amalgam</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compomer</intervention_name>
    <description>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.</description>
    <arm_group_label>Amalgam</arm_group_label>
    <arm_group_label>Giomer</arm_group_label>
    <arm_group_label>RMGIC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RMGIC</intervention_name>
    <description>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.</description>
    <arm_group_label>Amalgam</arm_group_label>
    <arm_group_label>Compomer</arm_group_label>
    <arm_group_label>Giomer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Giomer</intervention_name>
    <description>Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.</description>
    <arm_group_label>Amalgam</arm_group_label>
    <arm_group_label>Compomer</arm_group_label>
    <arm_group_label>RMGIC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Amalgam</intervention_name>
    <description>Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.</description>
    <arm_group_label>Compomer</arm_group_label>
    <arm_group_label>Giomer</arm_group_label>
    <arm_group_label>RMGIC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients and parent of the patients who accept to participate and sign the informed&#xD;
             consent&#xD;
&#xD;
          -  Patients who have at least four first and/or second primary molars with proximal&#xD;
             caries that require class II restorations&#xD;
&#xD;
          -  Teeth that have healthy lamina dura and periodontal ligament&#xD;
&#xD;
          -  Teeth that have caries lesions extending no more than the outher half of dentin&#xD;
             radiographically&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients and parent of the patients who don't accept to participate and sign the&#xD;
             informed consent&#xD;
&#xD;
          -  Teeth that are previously restored&#xD;
&#xD;
          -  Patients who are uncooperative&#xD;
&#xD;
          -  Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth&#xD;
&#xD;
          -  Patients who have bruxism, skeletal or dental malocclusion&#xD;
&#xD;
          -  Teeth that have developmental defects or anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zafer C Cehreli, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zafer C Cehreli, DDS, PhD</last_name>
    <phone>00905353197969</phone>
    <email>zcehreli@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Beste Ozgur, DDS, PhD</last_name>
    <phone>005072657769</phone>
    <email>besteisbitiren@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Zafer Cavit Cehreli, DDS, PhD</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <keyword>restorative materials</keyword>
  <keyword>primary teeth</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>26161601</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/pubmed/26161601</doc_url>
    </study_doc>
    <study_doc>
      <doc_id>19953810</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/pubmed/19953810</doc_url>
    </study_doc>
    <study_doc>
      <doc_id>12542617</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/pubmed/12542617</doc_url>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037814
org study id: HUDHF-3-primary teeth
nct id: NCT03037814
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
time frame: 5 years
description: Long-term clinical success of different restorative materials in class II cavities on primary molar teeth
arm group label: Compomer
arm group type: Other
description: Adhesive agent+Compomer
arm group label: RMGIC
arm group type: Other
description: Primer+RMGIC
arm group label: Giomer
arm group type: Other
description: Adhesive Agent+ Giomer
arm group label: Amalgam
arm group type: Other
description: Amalgam
intervention type: Device
intervention name: Compomer
description: 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.
arm group label: Amalgam
arm group label: Giomer
arm group label: RMGIC
intervention type: Device
intervention name: RMGIC
description: 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.
arm group label: Amalgam
arm group label: Compomer
arm group label: Giomer
intervention type: Device
intervention name: Giomer
description: Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
arm group label: Amalgam
arm group label: Compomer
arm group label: RMGIC
intervention type: Device
intervention name: Amalgam
description: Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
arm group label: Compomer
arm group label: Giomer
arm group label: RMGIC
criteria: 
gender: All
minimum age: 4 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zafer C Cehreli, DDS, PhD
role: Principal Investigator
affiliation: Hacettepe University
last name: Zafer C Cehreli, DDS, PhD
phone: 00905353197969
email: zcehreli@gmail.com
last name: Beste Ozgur, DDS, PhD
phone: 005072657769
email: besteisbitiren@yahoo.com
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Zafer Cavit Cehreli, DDS, PhD
investigator title: Prof
mesh term: Dental Caries
sharing ipd: No
study doc: 
study doc: 
study doc: 