<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/NCT04410172</url>
  </required_header>
  <id_info>
    <org_study_id>EMAN91</org_study_id>
    <nct_id>NCT04410172</nct_id>
  </id_info>
  <brief_title>Prevalence of MIH Among Group of Egyptians Children Aged From 8 to 12 in Damietta</brief_title>
  <official_title>Prevalence of Molar Incisor Hypomineralization Among a Group Of Egyptian Children Aged From 8 to 12 Years Old in Damietta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eman Zakaria Ali Hashem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian&#xD;
      children aged from 8 to 12 years old in Damietta governate. This study will determine the&#xD;
      severity of molar incisor hypomineralization which will help in its managment ,also will&#xD;
      increase the awareness pf pediatric dentists about the prevalence of molar incisor&#xD;
      hypomineralization in Egyptian children.Also it will allow the early detection of molar&#xD;
      incisor hypomineralization which will make the parents seek early treatment for it.&#xD;
      Participants fromprimary schools in Damietta governate will be included in the study. Clinica&#xD;
      examination will be carried out in the school lab or in embty class, in day light.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of molar incisor hypomineralization.</measure>
    <time_frame>On the same day of examination</time_frame>
    <description>Prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old. Participants will be examined in the school lab using disposable diagnostic set. Clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH based on EAPD. To diagnose MIH, at least one affected first permanent molar is required.</description>
  </primary_outcome>
  <enrollment type="Anticipated">129</enrollment>
  <condition>Molar Incisor Hypomineralization</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Mirror and prope</intervention_name>
    <description>Mirror and probe will be used for each patient. Mirrors for proper visualization especially for maxillary teeth, explorers will be used to aid in tactile sensation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A group of Egyptian children aged from 8 to 12 years old in Damietta governate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  positive subject acceptence for participation in the study.&#xD;
&#xD;
          -  children aged from 8 to 12 years old.&#xD;
&#xD;
          -  Eruption of at least two first permanent molars.&#xD;
&#xD;
          -  Both genders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncooperative child.&#xD;
&#xD;
          -  Children with prthodontic appliances.&#xD;
&#xD;
          -  Children with systemic diseases.&#xD;
&#xD;
          -  Children suffering from any other type of enamel defect as enamel hypoplasia.&#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_contact>
    <last_name>Eman Hashem, Master degree</last_name>
    <phone>(02) 01092990480</phone>
    <email>eman91hashem@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.</citation>
    <PMID>20403298</PMID>
  </reference>
  <reference>
    <citation>Allazzam SM, Alaki SM, El Meligy OA. Molar incisor hypomineralization, prevalence, and etiology. Int J Dent. 2014;2014:234508. doi: 10.1155/2014/234508. Epub 2014 May 8.</citation>
    <PMID>24949012</PMID>
  </reference>
  <reference>
    <citation>Biondi AM, Lopez Jordi Mdel C, Cortese SG, Alvarez L, Salveraglio I, Ortolani AM. Prevalence of molar-incisor hypomineralization (MIH) in children seeking dental care at the Schools of Dentistry of the University of Buenos Aires (Argentina) and University of la Republica (Uruguay). Acta Odontol Latinoam. 2012;25(2):224-30.</citation>
    <PMID>23230646</PMID>
  </reference>
  <reference>
    <citation>Buchgraber B, Kqiku L, Ebeleseder KA. Molar incisor hypomineralization: proportion and severity in primary public school children in Graz, Austria. Clin Oral Investig. 2018 Mar;22(2):757-762. doi: 10.1007/s00784-017-2150-y. Epub 2017 Jun 19.</citation>
    <PMID>28631087</PMID>
  </reference>
  <reference>
    <citation>Da Costa-Silva CM, Ambrosano GM, Jeremias F, De Souza JF, Mialhe FL. Increase in severity of molar-incisor hypomineralization and its relationship with the colour of enamel opacity: a prospective cohort study. Int J Paediatr Dent. 2011 Sep;21(5):333-41. doi: 10.1111/j.1365-263X.2011.01128.x. Epub 2011 Apr 6.</citation>
    <PMID>21470321</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Eman Zakaria Ali Hashem</investigator_full_name>
    <investigator_title>B.D.S, Faculty of Dentistry, Cairo University.</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/NCT04410172
org study id: EMAN91
nct id: NCT04410172
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian
      children aged from 8 to 12 years old in Damietta governate. This study will determine the
      severity of molar incisor hypomineralization which will help in its managment ,also will
      increase the awareness pf pediatric dentists about the prevalence of molar incisor
      hypomineralization in Egyptian children.Also it will allow the early detection of molar
      incisor hypomineralization which will make the parents seek early treatment for it.
      Participants fromprimary schools in Damietta governate will be included in the study. Clinica
      examination will be carried out in the school lab or in embty class, in day light.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: Prevalence of molar incisor hypomineralization.
time frame: On the same day of examination
description: Prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old. Participants will be examined in the school lab using disposable diagnostic set. Clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH based on EAPD. To diagnose MIH, at least one affected first permanent molar is required.
intervention type: Diagnostic Test
intervention name: Mirror and prope
description: Mirror and probe will be used for each patient. Mirrors for proper visualization especially for maxillary teeth, explorers will be used to aid in tactile sensation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eman Hashem, Master degree
phone: (02) 01092990480
email: eman91hashem@gmail.com
citation: Alaluusua S. Aetiology of Molar-Incisor Hypomineralisation: A systematic review. Eur Arch Paediatr Dent. 2010 Apr;11(2):53-8. doi: 10.1007/BF03262713.
PMID: 20403298
citation: Allazzam SM, Alaki SM, El Meligy OA. Molar incisor hypomineralization, prevalence, and etiology. Int J Dent. 2014;2014:234508. doi: 10.1155/2014/234508. Epub 2014 May 8.
PMID: 24949012
citation: Biondi AM, Lopez Jordi Mdel C, Cortese SG, Alvarez L, Salveraglio I, Ortolani AM. Prevalence of molar-incisor hypomineralization (MIH) in children seeking dental care at the Schools of Dentistry of the University of Buenos Aires (Argentina) and University of la Republica (Uruguay). Acta Odontol Latinoam. 2012;25(2):224-30.
PMID: 23230646
citation: Buchgraber B, Kqiku L, Ebeleseder KA. Molar incisor hypomineralization: proportion and severity in primary public school children in Graz, Austria. Clin Oral Investig. 2018 Mar;22(2):757-762. doi: 10.1007/s00784-017-2150-y. Epub 2017 Jun 19.
PMID: 28631087
citation: Da Costa-Silva CM, Ambrosano GM, Jeremias F, De Souza JF, Mialhe FL. Increase in severity of molar-incisor hypomineralization and its relationship with the colour of enamel opacity: a prospective cohort study. Int J Paediatr Dent. 2011 Sep;21(5):333-41. doi: 10.1111/j.1365-263X.2011.01128.x. Epub 2011 Apr 6.
PMID: 21470321
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Eman Zakaria Ali Hashem
investigator title: B.D.S, Faculty of Dentistry, Cairo University.
mesh term: Molar Hypomineralization
mesh term: Dental Enamel Hypoplasia