<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/NCT04475237</url>
  </required_header>
  <id_info>
    <org_study_id>SSM</org_study_id>
    <nct_id>NCT04475237</nct_id>
  </id_info>
  <brief_title>Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model</brief_title>
  <official_title>Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CADskills</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CADskills</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>
      Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will&#xD;
      be segmented and implemented into a statistical shape model that will be used to predict&#xD;
      missing hard tissue of a mandible based on the remaining bone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be&#xD;
      selected from the database (50 males and 50 females, between 20 and 60 years old). First,&#xD;
      they will be anonymized (except the sex and age/date of birth). Afterwards, they will be&#xD;
      segmented using Materialise Mimics software. The segmented mandibles will then be used to&#xD;
      create a statistical shape model (SSM) using principal component analysis. This model will&#xD;
      afterwards be used to predict the mandibular shapes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">May 5, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>A statistical shape model of a mandible</measure>
    <time_frame>2 months</time_frame>
    <description>A statistical shape model of a mandible</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Mandibular Diseases</condition>
  <condition>SSM</condition>
  <arm_group>
    <arm_group_label>Healthy mandibles</arm_group_label>
    <description>Belgian adults (between 20 and 60 years old), 50/50 male/female, with no major mandibular problems/deformities</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT-scan evaluation and segmentation</intervention_name>
    <description>CT-scans will be evaluated (to see if they are included in the research group) and segmented if they are accepted.</description>
    <arm_group_label>Healthy mandibles</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        European adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy mandibles&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mandibles with major deformities&#xD;
&#xD;
          -  Mandibles with obvious problems&#xD;
&#xD;
          -  Mandibles that already underwent surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CADskills HQ</name>
      <address>
        <city>Ghent</city>
        <state>East-Flanders</state>
        <zip>9051</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mandibular Diseases</mesh_term>
  </condition_browse>
  <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/NCT04475237
org study id: SSM
nct id: NCT04475237
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will
      be segmented and implemented into a statistical shape model that will be used to predict
      missing hard tissue of a mandible based on the remaining bone.
Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be
      selected from the database (50 males and 50 females, between 20 and 60 years old). First,
      they will be anonymized (except the sex and age/date of birth). Afterwards, they will be
      segmented using Materialise Mimics software. The segmented mandibles will then be used to
      create a statistical shape model (SSM) using principal component analysis. This model will
      afterwards be used to predict the mandibular shapes.
observational model: Ecologic or Community
time perspective: Retrospective
measure: A statistical shape model of a mandible
time frame: 2 months
description: A statistical shape model of a mandible
arm group label: Healthy mandibles
description: Belgian adults (between 20 and 60 years old), 50/50 male/female, with no major mandibular problems/deformities
intervention type: Other
intervention name: CT-scan evaluation and segmentation
description: CT-scans will be evaluated (to see if they are included in the research group) and segmented if they are accepted.
arm group label: Healthy mandibles
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Mandibular Diseases
sharing ipd: No