<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/NCT03234829</url>
  </required_header>
  <id_info>
    <org_study_id>MAtef</org_study_id>
    <nct_id>NCT03234829</nct_id>
  </id_info>
  <brief_title>Determination of Teeth Size in a Group of Egyptian Children. A Cross Sectional Study</brief_title>
  <official_title>Determination of The Combined Mesio-Distal Widths of The Permanent Mandibular Incisors and That of The Maxillary and Mandibular Canines and Premolars in a Group of Egyptian Children in Rural Areas of Sohag 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>
  <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>
      Determination of The Combined Mesio-Distal Widths of The Permanent Mandibular Incisors and&#xD;
      That of The Maxillary and Mandibular Canines and Premolars in a Group of Egyptian Children in&#xD;
      Rural Areas of Sohag Governorate: A Cross Sectional Study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Settings:&#xD;
&#xD;
        -  Students will be randomly selected from preparatory schools in rural areas of Sohag&#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;
        -  Operator: Master degree's student in Pediatric Dentistry and Dental Public Health.&#xD;
&#xD;
        -  Full mouth alginate impression will be taken and study models will be poured within one&#xD;
           hour with hard dental stone for each subject.&#xD;
&#xD;
        -  Mesio-distal widths of both maxillary and mandibular permanent incisors, canines, first&#xD;
           and second premolars will be measured from the study models using digital caliper&#xD;
           according to the method described by(Moorrees &amp; Reed, 1964) by measuring the greatest&#xD;
           distance between the contact points on the proximal surfaces holding the caliper&#xD;
           parallel to both occlusal and vestibular surfaces of the tooth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The combined mesio-distal widths of the permanent mandibular incisors, the maxillary canines, mandibular canines and premolars.</measure>
    <time_frame>one weak</time_frame>
    <description>using Digital Caliper the data will be recorded in Millimeter.</description>
  </primary_outcome>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Teeth Size in a Group of Egyptian Children</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Students will be randomly selected using simple random sampling from preparatory schools in&#xD;
        rural areas of Sohag governorate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who are apparently medically free from any systemic disease.&#xD;
&#xD;
          2. Patients aged between 12-15 years.&#xD;
&#xD;
          3. Full set of fully erupted permanent dentition from left 1st permanent molar to right&#xD;
             1st permanent molar.&#xD;
&#xD;
          4. No apparent orthodontics problem.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with craniofacial developmental abnormality.&#xD;
&#xD;
          2. Any sensitivity or adverse reactions to any of used materials.&#xD;
&#xD;
          3. Patients who refused to participate in the study.&#xD;
&#xD;
          4. Teeth with severe malalignment or rotation.&#xD;
&#xD;
          5. Teeth with any inaccuracy caused by impression taking, pouring impressions with dental&#xD;
             stone or any damage or breakage while the dental casts had been stored.&#xD;
&#xD;
          6. Teethwith notable wear, proximal decay, restorations, enamel hypoplasia or crown&#xD;
             fracture.&#xD;
&#xD;
          7. Teeth with developmental anomalies such as microdont teeth, teeth with extra cusps or&#xD;
             big talon cusps, or peg or conical shaped teeth.&#xD;
&#xD;
          8. Supernumerary or supplemental teeth (if present)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Eman S Elmasry, ass. prof</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oral and Dental Medicine Faculity</name>
      <address>
        <city>Cairo</city>
        <zip>11553</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Shaweesh AI. Mesiodistal and faciolingual diameters of the permanent teeth in a Jordanian population. Arch Oral Biol. 2017 Jan;73:253-258. doi: 10.1016/j.archoralbio.2016.10.026. Epub 2016 Oct 26.</citation>
    <PMID>27810383</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Atef</investigator_full_name>
    <investigator_title>oral and dental medicine, principle investigator</investigator_title>
  </responsible_party>
  <keyword>arch lengths, space analysis, arch prediction</keyword>
  <!-- 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/NCT03234829
org study id: MAtef
nct id: NCT03234829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determination of The Combined Mesio-Distal Widths of The Permanent Mandibular Incisors and
      That of The Maxillary and Mandibular Canines and Premolars in a Group of Egyptian Children in
      Rural Areas of Sohag Governorate: A Cross Sectional Study
Study Settings:

        -  Students will be randomly selected from preparatory schools in rural areas of Sohag
           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.

        -  Operator: Master degree's student in Pediatric Dentistry and Dental Public Health.

        -  Full mouth alginate impression will be taken and study models will be poured within one
           hour with hard dental stone for each subject.

        -  Mesio-distal widths of both maxillary and mandibular permanent incisors, canines, first
           and second premolars will be measured from the study models using digital caliper
           according to the method described by(Moorrees & Reed, 1964) by measuring the greatest
           distance between the contact points on the proximal surfaces holding the caliper
           parallel to both occlusal and vestibular surfaces of the tooth.
observational model: Case-Only
time perspective: Cross-Sectional
measure: The combined mesio-distal widths of the permanent mandibular incisors, the maxillary canines, mandibular canines and premolars.
time frame: one weak
description: using Digital Caliper the data will be recorded in Millimeter.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 15 Years
last name: Eman S Elmasry, ass. prof
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
citation: Shaweesh AI. Mesiodistal and faciolingual diameters of the permanent teeth in a Jordanian population. Arch Oral Biol. 2017 Jan;73:253-258. doi: 10.1016/j.archoralbio.2016.10.026. Epub 2016 Oct 26.
PMID: 27810383
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Atef
investigator title: oral and dental medicine, principle investigator