<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/NCT03025243</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-01-08</org_study_id>
    <nct_id>NCT03025243</nct_id>
  </id_info>
  <brief_title>The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides</brief_title>
  <official_title>The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides : A Randomized Clinical Trial</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of printing layer thickness on accuracy&#xD;
      of computer aided surgical guide&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Computer aided surgical guide has many variables that affect its accuracy , in this study one&#xD;
      variable is considered that may affect the accuracy of surgical guide which is printing of&#xD;
      layer thickness of surgical guide whether 50 micron or 100 micron.&#xD;
&#xD;
      computer aided surgical guide is constructed by imaging the patient pre-operative cone beam&#xD;
      CT wearing scan appliance , then virtual implant placement on special soft ware ( Blue sky&#xD;
      Bio ) and optical scanning of patient casts , afterword superimposition of the virtual&#xD;
      implants on the scanned casts to design the surgical guide and printing on 3D printer (&#xD;
      Zenith 3D printer , Dentis , Korea ) with printing layer thickness 50 micron in first group&#xD;
      and 100 micron in second group . Fixation of surgical guide in patient mouth and drilling of&#xD;
      implant osteotomy through the guiding sleeves , post-operative Cone Beam CT with the same&#xD;
      apparatus and setting as pre-operative scan .&#xD;
&#xD;
      Finally, the pre-operative and post operative scans were then overlapped to measure linear&#xD;
      and angular deviation of the virtually planned and actual implants position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>accuracy of surgical guide</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Guided Surgery</condition>
  <arm_group>
    <arm_group_label>50 micron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>surgical guide constructed with 3D printing with printing layer thickness 50 micron</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 micron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgical guide constructed with 3D printing with printing layer thickness 100 micron</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>computer aided surgical guide</intervention_name>
    <description>comparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT</description>
    <arm_group_label>100 micron</arm_group_label>
    <arm_group_label>50 micron</arm_group_label>
    <other_name>surgical guide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients partially or totally edentulous arches .&#xD;
&#xD;
          -  patients with Bucco-lingual bone thickness &gt;6 mm allowing flapless implant placement&#xD;
&#xD;
          -  patients free from any systemic diseases that may affect bone quality e.g diabetes .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with thin ridges.&#xD;
&#xD;
          -  patients with systemic disease that may affect bone quality.&#xD;
&#xD;
          -  Patients with poor oral hygiene and active periodontal diseases.&#xD;
&#xD;
          -  Anatomical situations requiring regenerative procedure.&#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>
  <overall_official>
    <last_name>Mahmoud El far, phd</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amr M Hanafy, master</last_name>
    <phone>01111228022</phone>
    <email>amrhanafy201055@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amr H El-Khadem, phd</last_name>
    <phone>01001162401</phone>
    <email>amrelkhadem@gmail.com</email>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amr Mohamed Ahmed Hanafy</investigator_full_name>
    <investigator_title>Master students</investigator_title>
  </responsible_party>
  <keyword>computer aided design , dental implants , accuracy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03025243
org study id: CEBC-CU-2017-01-08
nct id: NCT03025243
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect of printing layer thickness on accuracy
      of computer aided surgical guide
Computer aided surgical guide has many variables that affect its accuracy , in this study one
      variable is considered that may affect the accuracy of surgical guide which is printing of
      layer thickness of surgical guide whether 50 micron or 100 micron.

      computer aided surgical guide is constructed by imaging the patient pre-operative cone beam
      CT wearing scan appliance , then virtual implant placement on special soft ware ( Blue sky
      Bio ) and optical scanning of patient casts , afterword superimposition of the virtual
      implants on the scanned casts to design the surgical guide and printing on 3D printer (
      Zenith 3D printer , Dentis , Korea ) with printing layer thickness 50 micron in first group
      and 100 micron in second group . Fixation of surgical guide in patient mouth and drilling of
      implant osteotomy through the guiding sleeves , post-operative Cone Beam CT with the same
      apparatus and setting as pre-operative scan .

      Finally, the pre-operative and post operative scans were then overlapped to measure linear
      and angular deviation of the virtually planned and actual implants position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Outcomes Assessor)
measure: accuracy of surgical guide
time frame: 6 months
arm group label: 50 micron
arm group type: Experimental
description: surgical guide constructed with 3D printing with printing layer thickness 50 micron
arm group label: 100 micron
arm group type: Active Comparator
description: surgical guide constructed with 3D printing with printing layer thickness 100 micron
intervention type: Device
intervention name: computer aided surgical guide
description: comparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT
arm group label: 100 micron
arm group label: 50 micron
other name: surgical guide
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud El far, phd
role: Study Director
affiliation: Cairo University
last name: Amr M Hanafy, master
phone: 01111228022
email: amrhanafy201055@yahoo.com
last name: Amr H El-Khadem, phd
phone: 01001162401
email: amrelkhadem@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amr Mohamed Ahmed Hanafy
investigator title: Master students
sharing ipd: Undecided