<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/NCT03277443</url>
  </required_header>
  <id_info>
    <org_study_id>292017</org_study_id>
    <nct_id>NCT03277443</nct_id>
  </id_info>
  <brief_title>Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite</brief_title>
  <official_title>Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ammar Ribhi Abu shama</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical&#xD;
      outcomes and accuracy versus conventional model surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      P Adult Patients with skeletal open bite.&#xD;
&#xD;
      I Computer guided surgery.&#xD;
&#xD;
      C Conventional articulating model surgery&#xD;
&#xD;
      O Outcome measure:&#xD;
&#xD;
      Outcome Name Measuring Device Measuring Unit (mm)&#xD;
&#xD;
      O1 Accuracy&#xD;
&#xD;
      Computer guided: Super-imposition of virtual surgery over the post- operative CT Scan&#xD;
      composite models ( millimeter mm)&#xD;
&#xD;
      Conventional : Super-imposition of scanned articulator with mounted casts in the pre-planned&#xD;
      mock surgery over post-operative scanned mounted occlusion ( millimeter mm)&#xD;
&#xD;
      O2 Anterior open Bite Closure&#xD;
&#xD;
      Standardized Multi Scan CT (millimeter mm)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2018</start_date>
  <completion_date type="Anticipated">May 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>Single Group Assignment</intervention_model>
    <intervention_model_description>SM and VSM</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of movement of surgical segments in millimeter</measure>
    <time_frame>up to 4 months</time_frame>
    <description>Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm).&#xD;
Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anterior open Bite Closure (positive overbite in millimeter)</measure>
    <time_frame>up to 4 months</time_frame>
    <description>Standardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Apertognathia</condition>
  <arm_group>
    <arm_group_label>Conventional Model Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lateral Cephalogram with analysis and tracing of facial profile.&#xD;
Modified model surgical tecnique:&#xD;
Obtain wax bite registration.&#xD;
Record face-bow transfer.&#xD;
Duplication of articulating model for surgical simulation.&#xD;
Measure all casts and bases in standard model surgery fashion.&#xD;
Fabricate intermediate splint &amp; Final splint.&#xD;
Condylar repositional splint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computer guided surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.&#xD;
Computer-aided planning for study group:&#xD;
All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation.&#xD;
Pre-operative Fabrication of computer aided surgical splint:&#xD;
In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes.&#xD;
So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computer guided surgery</intervention_name>
    <description>Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.Craniofacial images from 3D computerized tomography (3D-CT scan) can be used to create a 3D model, which can in turn be used for 3D Cephalometry measurements and surgical simulation.The process of 3D-model contains mounting of 3D virtual models in a 3D virtual articulator; and repositioning of 3D virtual models according to the STO then Fabrication of a 3D virtual intermediate surgical wafer; and materialization of the surgical wafer using a stereolithographic technique. The 3D model can produce actual movement of surgical cuts and movement of segments accordingly</description>
    <arm_group_label>Computer guided surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional model surgery</intervention_name>
    <description>preparation for orthognathic surgery which involves diagnosis with 2D cephalometric radiograph, face-bow transfer and model surgery on plaster dental cast, and fabrication of intermediate and final occlusal splint.</description>
    <arm_group_label>Conventional Model Surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2D cephalometric radiograph</intervention_name>
    <description>2D cephalometric radiograph</description>
    <arm_group_label>Conventional Model Surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D computerized tomography</intervention_name>
    <description>3D computerized tomography</description>
    <arm_group_label>Computer guided surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from skeletal open bite caused by vertical posterior maxillary&#xD;
             excess and/or short mandible ramus.&#xD;
&#xD;
          -  Patients should be free from any systemic disease that may affect normal healing, and&#xD;
             predictable outcome.&#xD;
&#xD;
          -  Required two jaws orthographic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any systemic disease that may affect normal healing&#xD;
&#xD;
          -  Intra-bony lesions or infections that may retard the osteotomy healing.&#xD;
&#xD;
          -  Patient with bad oral hygiene.&#xD;
&#xD;
          -  Uncontrolled Diabetes mellitus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moustafa K Ezz, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ammar R Abu Shama, PHD</last_name>
    <phone>00201142354052</phone>
    <email>Dr.ammar.shama@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mamdouh S Sayed Ahmed, Professor</last_name>
    <phone>00201222173262</phone>
    <email>dr.mamdouhahmed@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>February 13, 2018</last_update_submitted>
  <last_update_submitted_qc>February 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ammar Ribhi Abu shama</investigator_full_name>
    <investigator_title>PHD Doctor in Oral and Maxillofacial Surgery</investigator_title>
  </responsible_party>
  <keyword>Skeletal open bite</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Open Bite</mesh_term>
  </condition_browse>
  <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/NCT03277443
org study id: 292017
nct id: NCT03277443
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical
      outcomes and accuracy versus conventional model surgery
P Adult Patients with skeletal open bite.

      I Computer guided surgery.

      C Conventional articulating model surgery

      O Outcome measure:

      Outcome Name Measuring Device Measuring Unit (mm)

      O1 Accuracy

      Computer guided: Super-imposition of virtual surgery over the post- operative CT Scan
      composite models ( millimeter mm)

      Conventional : Super-imposition of scanned articulator with mounted casts in the pre-planned
      mock surgery over post-operative scanned mounted occlusion ( millimeter mm)

      O2 Anterior open Bite Closure

      Standardized Multi Scan CT (millimeter mm)
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: SM and VSM
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Accuracy of movement of surgical segments in millimeter
time frame: up to 4 months
description: Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm).
Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm).
measure: Anterior open Bite Closure (positive overbite in millimeter)
time frame: up to 4 months
description: Standardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph.
arm group label: Conventional Model Surgery
arm group type: Active Comparator
description: Lateral Cephalogram with analysis and tracing of facial profile.
Modified model surgical tecnique:
Obtain wax bite registration.
Record face-bow transfer.
Duplication of articulating model for surgical simulation.
Measure all casts and bases in standard model surgery fashion.
Fabricate intermediate splint & Final splint.
Condylar repositional splint.
arm group label: Computer guided surgery
arm group type: Experimental
description: Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.
Computer-aided planning for study group:
All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation.
Pre-operative Fabrication of computer aided surgical splint:
In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes.
So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning.
intervention type: Procedure
intervention name: Computer guided surgery
description: Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.Craniofacial images from 3D computerized tomography (3D-CT scan) can be used to create a 3D model, which can in turn be used for 3D Cephalometry measurements and surgical simulation.The process of 3D-model contains mounting of 3D virtual models in a 3D virtual articulator; and repositioning of 3D virtual models according to the STO then Fabrication of a 3D virtual intermediate surgical wafer; and materialization of the surgical wafer using a stereolithographic technique. The 3D model can produce actual movement of surgical cuts and movement of segments accordingly
arm group label: Computer guided surgery
intervention type: Procedure
intervention name: Conventional model surgery
description: preparation for orthognathic surgery which involves diagnosis with 2D cephalometric radiograph, face-bow transfer and model surgery on plaster dental cast, and fabrication of intermediate and final occlusal splint.
arm group label: Conventional Model Surgery
intervention type: Device
intervention name: 2D cephalometric radiograph
description: 2D cephalometric radiograph
arm group label: Conventional Model Surgery
intervention type: Device
intervention name: 3D computerized tomography
description: 3D computerized tomography
arm group label: Computer guided surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moustafa K Ezz, Professor
role: Study Director
affiliation: Cairo University
last name: Ammar R Abu Shama, PHD
phone: 00201142354052
email: Dr.ammar.shama@gmail.com
last name: Mamdouh S Sayed Ahmed, Professor
phone: 00201222173262
email: dr.mamdouhahmed@hotmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Ammar Ribhi Abu shama
investigator title: PHD Doctor in Oral and Maxillofacial Surgery
mesh term: Open Bite
sharing ipd: Undecided