<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/NCT03229018</url>
  </required_header>
  <id_info>
    <org_study_id>1611</org_study_id>
    <nct_id>NCT03229018</nct_id>
  </id_info>
  <brief_title>Effect of Different Voxel Sizes on Accuracy of CBCT Linear Measurements: Preclinical Study</brief_title>
  <official_title>Effect of Different Voxel Sizes on Accuracy of 2D and 3D Mandibular Linear Measurements Using CRANEX® 3D Cone Beam Computed Tomography Machine: Preclinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</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>
      study target is assessment of the accuracy of linear measurement obtained from CBCT images on&#xD;
      3D volumetric rendering and multiplanar slices with different voxel sizes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The real linear measurement will be measured in millimeter (mm) on the mandibles using&#xD;
      digital caliper in the chosen areas.&#xD;
&#xD;
      CBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D&#xD;
      ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the&#xD;
      dimension in the chosen areas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of linear measurement</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">9</enrollment>
  <condition>Cone-Beam Computed Tomography</condition>
  <arm_group>
    <arm_group_label>voxel size</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>200 μm and 300 μm Voxel Sizes</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Voxel size</intervention_name>
    <description>200 μm and 300 μm Voxel Sizes</description>
    <arm_group_label>voxel size</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Selection of the human dry mandibles will be independent of age, gender and ethnicity.&#xD;
&#xD;
          -  They should be intact, free from any bone defects, fractures, pathology.&#xD;
&#xD;
          -  Dentate state of the mandibles is not an element in selection criteria; either&#xD;
             dentulous or edentulous mandibles are acceptable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed Selim, BDs</last_name>
    <phone>+201147703022</phone>
    <email>Mohamed.selim@dentistry.cu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Cairo</city>
        <zip>11511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Ahmed Mohamed Selim</investigator_full_name>
    <investigator_title>Master student</investigator_title>
  </responsible_party>
  <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/NCT03229018
org study id: 1611
nct id: NCT03229018
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
study target is assessment of the accuracy of linear measurement obtained from CBCT images on
      3D volumetric rendering and multiplanar slices with different voxel sizes
The real linear measurement will be measured in millimeter (mm) on the mandibles using
      digital caliper in the chosen areas.

      CBCT images will be viewed by OnDemand3D™ viewer software and linear measurements using 2D
      ruler on multiplanar slices and 3D ruler on 3D volumetric rendering to assess for the
      dimension in the chosen areas.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic accuracy of linear measurement
time frame: 1 year
description: Assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes
arm group label: voxel size
arm group type: Other
description: 200 μm and 300 μm Voxel Sizes
intervention type: Diagnostic Test
intervention name: Voxel size
description: 200 μm and 300 μm Voxel Sizes
arm group label: voxel size
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed Selim, BDs
phone: +201147703022
email: Mohamed.selim@dentistry.cu.edu.eg
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Ahmed Mohamed Selim
investigator title: Master student
sharing ipd: No