<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/NCT04420520</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2020-05-13</org_study_id>
    <nct_id>NCT04420520</nct_id>
  </id_info>
  <brief_title>Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools</brief_title>
  <official_title>Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools: A Cross Sectional Study</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>Yes</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>
      Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian&#xD;
      Children in Fayoum Governorate Schools via clinical examination.&#xD;
&#xD;
      Participants from primary and preparatory schools in Fayoum governorate will be included in&#xD;
      the study and Clinical examination will be carried out in the school laboratory or an empty&#xD;
      class, in day light for both genders.&#xD;
&#xD;
      Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable&#xD;
      diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for&#xD;
      proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in&#xD;
      tactile sensation if needed, as during the differentiation between rough and smooth enamel&#xD;
      edges and/or during the inspection of the caries extent if it exists. No diagnostic&#xD;
      radiographs will be taken.&#xD;
&#xD;
      The results of the study will be regularly monitored by the supervisors who will have full&#xD;
      access to these results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 20, 2020</start_date>
  <completion_date type="Anticipated">May 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 20, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Prevalence of Molar Incisor Hypomineralization</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light.</description>
  </primary_outcome>
  <enrollment type="Anticipated">135</enrollment>
  <condition>Molar Incisor Hypomineralization</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptian children in Fayoum governorate schools.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acceptance for participation in the study.&#xD;
&#xD;
          -  Eruption of four first permanent molars.&#xD;
&#xD;
          -  Eruption of four permanent maxillary and mandibular incisors.&#xD;
&#xD;
          -  Both genders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncooperative children.&#xD;
&#xD;
          -  Children with orthodontic appliances.&#xD;
&#xD;
          -  Children with systemic diseases which may affect teeth development.&#xD;
&#xD;
          -  Children suffering from any other type of enamel defect as enamel hypoplasia and&#xD;
             amelogenesis imperfecta.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Alaa Snoussy Abo-alsaod</investigator_full_name>
    <investigator_title>Pricipal Investigator</investigator_title>
  </responsible_party>
  <keyword>MIH</keyword>
  <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>
  <!-- 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/NCT04420520
org study id: CEBD-CU-2020-05-13
nct id: NCT04420520
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian
      Children in Fayoum Governorate Schools via clinical examination.

      Participants from primary and preparatory schools in Fayoum governorate will be included in
      the study and Clinical examination will be carried out in the school laboratory or an empty
      class, in day light for both genders.

      Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable
      diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for
      proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in
      tactile sensation if needed, as during the differentiation between rough and smooth enamel
      edges and/or during the inspection of the caries extent if it exists. No diagnostic
      radiographs will be taken.

      The results of the study will be regularly monitored by the supervisors who will have full
      access to these results.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of Molar Incisor Hypomineralization
time frame: Through study completion, an average of 1 year
description: Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Alaa Snoussy Abo-alsaod
investigator title: Pricipal Investigator
mesh term: Molar Hypomineralization
mesh term: Dental Enamel Hypoplasia