<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/NCT04475419</url>
  </required_header>
  <id_info>
    <org_study_id>01008322329</org_study_id>
    <nct_id>NCT04475419</nct_id>
  </id_info>
  <brief_title>Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization</brief_title>
  <official_title>Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Restoration quality of molars affected by MIH using two different types of restorations&#xD;
      direct composite and preformed crowns&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MIH or molar incisor hypomineralization is one of the difficult clinical situations to be&#xD;
      managed by dentists the aim of this study is to specify which is the better treatment among&#xD;
      composite restorations and preformed crowns in terms of gingival health patient satisfaction&#xD;
      pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future&#xD;
      retreatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>
    <intervention_model_description>parallel groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain after the restoration .Binary (yes or No)</measure>
    <time_frame>12 MONTHS</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the treatment Binary (yes or No)</measure>
    <time_frame>12 months</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>restoration quality Score index</measure>
    <time_frame>12 months</time_frame>
    <description>(FDI criteria; criterion marginal adaptation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health-related quality of life changes by the therapies</measure>
    <time_frame>12 months</time_frame>
    <description>measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Molar Incisor Hypomineralization</condition>
  <arm_group>
    <arm_group_label>Direct composite restorations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preformed metal crowns</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)</intervention_name>
    <description>covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)</description>
    <arm_group_label>Direct composite restorations</arm_group_label>
    <arm_group_label>preformed metal crowns</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        .Children with molar incisor hypo mineralization in one fully erupted molar or more.&#xD;
&#xD;
          -  Age ranging from 7-12 years.&#xD;
&#xD;
          -  Cooperative children&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in other experiments .Patients with parents planning to move&#xD;
             away within the following year.&#xD;
&#xD;
          -  Patients with only mildly affected MIH molars that do not require extensive&#xD;
             restorative treatment.&#xD;
&#xD;
          -  MIH-affected molars that have a very poor prognosis and require extraction.&#xD;
&#xD;
          -  First permanent molars that are affected with other developmental defects, such as&#xD;
             hypoplasia, dental fluorosis or amelogenesis imperfecta.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>manalf M elshiekh, MASTER</last_name>
    <role>Study Chair</role>
    <affiliation>CU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eman m elmasry, PHD</last_name>
    <phone>01001651946</phone>
    <phone_ext>12345</phone_ext>
    <email>Mahmoued_dentist3@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>osama M alshahawy, master</last_name>
    <phone>01001651946</phone>
    <phone_ext>12345</phone_ext>
    <email>Mahmoued_dentist3@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2019</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mahmoud mohamed hassan</investigator_full_name>
    <investigator_title>Assisstant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molar Hypomineralization</mesh_term>
    <mesh_term>Dental Enamel Hypoplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04475419
org study id: 01008322329
nct id: NCT04475419
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Restoration quality of molars affected by MIH using two different types of restorations
      direct composite and preformed crowns
MIH or molar incisor hypomineralization is one of the difficult clinical situations to be
      managed by dentists the aim of this study is to specify which is the better treatment among
      composite restorations and preformed crowns in terms of gingival health patient satisfaction
      pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future
      retreatment
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: parallel groups
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: pain after the restoration .Binary (yes or No)
time frame: 12 MONTHS
description: questionnaire
measure: Acceptability of the treatment Binary (yes or No)
time frame: 12 months
description: questionnaire
measure: restoration quality Score index
time frame: 12 months
description: (FDI criteria; criterion marginal adaptation)
measure: health-related quality of life changes by the therapies
time frame: 12 months
description: measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14)
arm group label: Direct composite restorations
arm group type: Active Comparator
description: bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)
arm group label: preformed metal crowns
arm group type: Active Comparator
description: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
intervention type: Procedure
intervention name: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
description: covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
arm group label: Direct composite restorations
arm group label: preformed metal crowns
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: manalf M elshiekh, MASTER
role: Study Chair
affiliation: CU
last name: Eman m elmasry, PHD
phone: 01001651946
phone ext: 12345
email: Mahmoued_dentist3@yahoo.com
last name: osama M alshahawy, master
phone: 01001651946
phone ext: 12345
email: Mahmoued_dentist3@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mahmoud mohamed hassan
investigator title: Assisstant lecturer
mesh term: Molar Hypomineralization
mesh term: Dental Enamel Hypoplasia
sharing ipd: No