xml: <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/NCT06035432</url>
    </required_header>
    <id_info>
      <org_study_id>Digital Models 2023</org_study_id>
      <nct_id>NCT06035432</nct_id>
    </id_info>
    <brief_title>Accuracy of Digital Models Using Open-access Software Programs</brief_title>
    <official_title>Trueness and Precision of Digital Models Obtained From Different Open-access Software Programs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hams Hamed Abdelrahman</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria 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>
        Background: Despite the clear drive toward digital model transformation, there are&#xD;
        limitations to some paid software necessary for digital model production. The aim of the&#xD;
        study is to compare the accuracy of open-access software against paid software regarding the&#xD;
        segmentation process to produce a digital model. Four groups of software programs will be&#xD;
        assessed regarding their accuracy in the segmentation process to produce a digital dental&#xD;
        model. The reference models will be scanned by a desktop scanner and will be set as the gold&#xD;
        standard. The same models will be scanned by the same CBCT machine. The obtained DICOM data&#xD;
        will be converted into STL files by four different software programs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 30, 2023</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Deviation in digital models measurments</measure>
      <time_frame>through study completion, up to 3 months</time_frame>
      <description>3D deviation analysis will be done between the digital models of each participant and the reference model by reverse engineering 3-Matics software (Materialise NV, Belgium, Version 11.0). Each two STL models will be imported into the software. The mean deviation difference (measured in mm) will be calculated by 'Analyse' tool present in the software</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Linear measurements</measure>
      <time_frame>through study completion, up to 3 months</time_frame>
      <description>Each digital model will be measured in the three dimensions:&#xD;
  Anteroposterior (the canine cusp tip to the mesiobuccal cusp tip of the first molar on the right side).&#xD;
  Transverse (inter-canine and inter-molar).&#xD;
  Vertical (the canine height, which is measured from the cusp tip to the gingival margin of the right canine by a line parallel to the long axis of the tooth).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Teeth crown width</measure>
      <time_frame>through study completion, up to 3 months</time_frame>
      <description>For all teeth (twelve measurements for each arch), first molar to first molar, in both arches, the tooth measurements will include the mesiodistal widths from point contact to point contact.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">18</enrollment>
    <condition>Accuracy of Digital Dental Model</condition>
    <arm_group>
      <arm_group_label>Open access software 1</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Open access software 2</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Non open access paid software 1</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Non open access paid software 2</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Bluesky software</intervention_name>
      <description>Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Bluesky software.</description>
      <arm_group_label>Open access software 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>3D slicer software</intervention_name>
      <description>Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by 3D slicer software.</description>
      <arm_group_label>Open access software 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>OnDemand software</intervention_name>
      <description>Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by OnDemand software.</description>
      <arm_group_label>Non open access paid software 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mimics software</intervention_name>
      <description>Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Mimics software.</description>
      <arm_group_label>Non open access paid software 2</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are young adults attending the Periodontology, Oral Medicine, Diagnosis and&#xD;
          Oral Radiology Department, Faculty of Dentistry, Alexandria University.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Complete records of patients (upper and lower).&#xD;
  &#xD;
            -  Intact models with complete anatomy.&#xD;
  &#xD;
            -  Complete permanent dentition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Broken or damaged stone models.&#xD;
  &#xD;
            -  Models of patients with orthodontic appliances or dental prosthesis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Noha ElKersh, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alexandria University, Faculty of Dentistry</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Alexandria Faculty of Dentistry</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name>
      <investigator_title>Assistant lecturer of DPH and Clinical statistician</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035432
  org study id: Digital Models 2023
  nct id: NCT06035432
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background: Despite the clear drive toward digital model transformation, there are
        limitations to some paid software necessary for digital model production. The aim of the
        study is to compare the accuracy of open-access software against paid software regarding the
        segmentation process to produce a digital model. Four groups of software programs will be
        assessed regarding their accuracy in the segmentation process to produce a digital dental
        model. The reference models will be scanned by a desktop scanner and will be set as the gold
        standard. The same models will be scanned by the same CBCT machine. The obtained DICOM data
        will be converted into STL files by four different software programs.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Deviation in digital models measurments
  time frame: through study completion, up to 3 months
  description: 3D deviation analysis will be done between the digital models of each participant and the reference model by reverse engineering 3-Matics software (Materialise NV, Belgium, Version 11.0). Each two STL models will be imported into the software. The mean deviation difference (measured in mm) will be calculated by 'Analyse' tool present in the software
  measure: Linear measurements
  time frame: through study completion, up to 3 months
  description: Each digital model will be measured in the three dimensions:
  Anteroposterior (the canine cusp tip to the mesiobuccal cusp tip of the first molar on the right side).
  Transverse (inter-canine and inter-molar).
  Vertical (the canine height, which is measured from the cusp tip to the gingival margin of the right canine by a line parallel to the long axis of the tooth).
  measure: Teeth crown width
  time frame: through study completion, up to 3 months
  description: For all teeth (twelve measurements for each arch), first molar to first molar, in both arches, the tooth measurements will include the mesiodistal widths from point contact to point contact.
  arm group label: Open access software 1
  arm group label: Open access software 2
  arm group label: Non open access paid software 1
  arm group label: Non open access paid software 2
  intervention type: Other
  intervention name: Bluesky software
  description: Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Bluesky software.
  arm group label: Open access software 1
  intervention type: Other
  intervention name: 3D slicer software
  description: Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by 3D slicer software.
  arm group label: Open access software 2
  intervention type: Other
  intervention name: OnDemand software
  description: Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by OnDemand software.
  arm group label: Non open access paid software 1
  intervention type: Other
  intervention name: Mimics software
  description: Dental stone casts will be scanned with a desktop scanner and then STL files will be exported. Virtual 3D surface models will be obtained by Mimics software.
  arm group label: Non open access paid software 2
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 30 Years
  healthy volunteers: No
  last name: Noha ElKersh, PhD
  role: Principal Investigator
  affiliation: Alexandria University, Faculty of Dentistry
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Alexandria University
  investigator full name: Hams Hamed Abdelrahman
  investigator title: Assistant lecturer of DPH and Clinical statistician