<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/NCT03233464</url>
  </required_header>
  <id_info>
    <org_study_id>ARefaat</org_study_id>
    <nct_id>NCT03233464</nct_id>
  </id_info>
  <brief_title>Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate</brief_title>
  <acronym>MIH</acronym>
  <official_title>Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Giza Governorate: 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>
  <brief_summary>
    <textblock>
      - One single operator will assess the prevalence of molar incisor hypomineralization and its&#xD;
      Severity among a group of Egyptian children .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the study is about the prevalance of molar incisor hypomineralization and its severity among&#xD;
      a group of Egyptian children aged 8-12 years old in Giza Governorate schools.&#xD;
&#xD;
        -  Participants will be randomly selected from primary and preparatory schools in Giza&#xD;
           governorate, seated in the school lap or an empty classroom.&#xD;
&#xD;
        -  Clinical examination will be made in the daylight using disposable diagnostic sets&#xD;
           (mirror, and explorer). No diagnostic radiographs will be taken.&#xD;
&#xD;
        -  Prior to performing dental examination, index teeth including incisors and 1st permanent&#xD;
           molars will be cleaned using a cotton roll.&#xD;
&#xD;
        -  A dental explorer will be further used for cleaning molar fissures.&#xD;
&#xD;
        -  The examiner carefully inspect the coronal part of the 1st permanent molars and&#xD;
           permanent incisors for demarcated opacities.&#xD;
&#xD;
        -  A specially made examination chart will be taken for the child including his name, age,&#xD;
           address, gender, school, date, medical health and any previous dental treatment.&#xD;
&#xD;
      prevalance of molar incisor hypomineralization is measured by presence or absence.&#xD;
&#xD;
      severity is measured by Modified index based on European Academy of Paediatric Dentistry&#xD;
      (EAPD) criteria&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">May 2018</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>molar incisor hypomineralization</measure>
    <time_frame>20 mins</time_frame>
    <description>prevalance of molar incisor hypomineralization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>molar incisor hypomineralization</measure>
    <time_frame>20 mins</time_frame>
    <description>severity of molar incisor hypomineralization</description>
  </secondary_outcome>
  <enrollment type="Anticipated">374</enrollment>
  <condition>Molar Incisor Hypomineralization</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A group of Egyptian children aged 8-12 years old in Giza Governorate schools.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  schools in Giza Governorate.&#xD;
&#xD;
          -  Positive patient acceptance for participation in the study.&#xD;
&#xD;
          -  Patients who are apparently medically free from any systemic disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncooperative child.&#xD;
&#xD;
          -  Children with appliances.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aya R Abd El-Ghaffar, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aya Refaat Abd El-Ghaffar</name>
      <address>
        <city>Giza,Egypt</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Yannam SD, Amarlal D, Rekha CV. Prevalence of molar incisor hypomineralization in school children aged 8-12 years in Chennai. J Indian Soc Pedod Prev Dent. 2016 Apr-Jun;34(2):134-8. doi: 10.4103/0970-4388.180438.</citation>
    <PMID>27080963</PMID>
  </results_reference>
  <results_reference>
    <citation>Salem K, Aziz D, Asadi M. Prevalence and Predictors of Molar Incisor Hypomineralization (MIH) among Rural Children in Northern Iran. Iran J Public Health. 2016 Nov;45(11):1528-1530. No abstract available.</citation>
    <PMID>28032070</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>February 10, 2018</last_update_submitted>
  <last_update_submitted_qc>February 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Aya Refaat Abd El-Ghaffar</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <!-- 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/NCT03233464
org study id: ARefaat
nct id: NCT03233464
lead sponsor: 
- One single operator will assess the prevalence of molar incisor hypomineralization and its
      Severity among a group of Egyptian children .
the study is about the prevalance of molar incisor hypomineralization and its severity among
      a group of Egyptian children aged 8-12 years old in Giza Governorate schools.

        -  Participants will be randomly selected from primary and preparatory schools in Giza
           governorate, seated in the school lap or an empty classroom.

        -  Clinical examination will be made in the daylight using disposable diagnostic sets
           (mirror, and explorer). No diagnostic radiographs will be taken.

        -  Prior to performing dental examination, index teeth including incisors and 1st permanent
           molars will be cleaned using a cotton roll.

        -  A dental explorer will be further used for cleaning molar fissures.

        -  The examiner carefully inspect the coronal part of the 1st permanent molars and
           permanent incisors for demarcated opacities.

        -  A specially made examination chart will be taken for the child including his name, age,
           address, gender, school, date, medical health and any previous dental treatment.

      prevalance of molar incisor hypomineralization is measured by presence or absence.

      severity is measured by Modified index based on European Academy of Paediatric Dentistry
      (EAPD) criteria
observational model: Other
time perspective: Cross-Sectional
measure: molar incisor hypomineralization
time frame: 20 mins
description: prevalance of molar incisor hypomineralization
measure: molar incisor hypomineralization
time frame: 20 mins
description: severity of molar incisor hypomineralization
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aya R Abd El-Ghaffar, Bachelor
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
citation: Yannam SD, Amarlal D, Rekha CV. Prevalence of molar incisor hypomineralization in school children aged 8-12 years in Chennai. J Indian Soc Pedod Prev Dent. 2016 Apr-Jun;34(2):134-8. doi: 10.4103/0970-4388.180438.
PMID: 27080963
citation: Salem K, Aziz D, Asadi M. Prevalence and Predictors of Molar Incisor Hypomineralization (MIH) among Rural Children in Northern Iran. Iran J Public Health. 2016 Nov;45(11):1528-1530. No abstract available.
PMID: 28032070
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Aya Refaat Abd El-Ghaffar
investigator title: Principal Investigator
mesh term: Molar Hypomineralization
mesh term: Dental Enamel Hypoplasia