<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/NCT03757286</url>
  </required_header>
  <id_info>
    <org_study_id>654</org_study_id>
    <nct_id>NCT03757286</nct_id>
  </id_info>
  <brief_title>Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using FSF With and Without CAD/CAM Customized Cutting Guide</brief_title>
  <official_title>Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using Free Scapular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled 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>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>
      The aim of the study is to compare aesthetic results and operation time of Free Scapular flap&#xD;
      with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maxillofacial defects create unique challenges for the reconstructive surgeon, often&#xD;
      involving bony and soft tissue components of the midface. Surgical reconstruction following&#xD;
      maxillectomy is currently a topic of interest for reconstructive head and neck surgeons.&#xD;
      maxillary defects were reconstructed with maxillofacial prosthetics including obturation.&#xD;
      While the latter is an effective reconstruction. Over the past two decades, there has been&#xD;
      increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla.&#xD;
&#xD;
      Scapular flap It is an excellent candidate for maxillectomy defects because of its unique&#xD;
      feature, which is characterized by additional skin paddles or muscles. and can be harvested&#xD;
      along with a part of the scapular bone for bony reconstruction&#xD;
&#xD;
      Traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact&#xD;
      planning, poor communication between the resective and reconstructive teams or surgical&#xD;
      difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3D)&#xD;
      defect without the help of any templates or surgical guides The advent of 3D modeling in head&#xD;
      and neck reconstruction has allowed surgeons to improve upon functional and aesthetic&#xD;
      outcomes, which are crucial to patient satisfaction and can be difficult to achieve in&#xD;
      maxillectomy defects The cutting guides used or not used, however debate still present for&#xD;
      its benefits and worth for patient and surgeon. current study to evaluate how such virtual&#xD;
      planning with using of customized cutting guide is effective and worth for patient aesthetic&#xD;
      and operation time.&#xD;
&#xD;
      our priori-hypothesis is that utilization CAD/CAM assisted with customized osteotomy guide is&#xD;
      not related to an altered result regarding aesthetic outcome and operation time in patient&#xD;
      undergoing maxillary reconstruction using free scapular flap.&#xD;
&#xD;
      In order to test this hypothesis, we will compare aesthetic outcome and operation time in&#xD;
      group of patients receive FSF by CAD/CAM-assisted with customized osteotomy guide to results&#xD;
      of another group of patients receive FSF but without customized osteotomy guide. only model&#xD;
      will be performed as conventional method aiding in reshaping of reconstruction plate which is&#xD;
      another well-established concept of management of maxillary defect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Aesthetic</measure>
    <time_frame>at least three months postoperative</time_frame>
    <description>aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to other side of maxilla.subjectively will be evaluated using VAS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>intraoperative</time_frame>
    <description>operation time will be recorded intraoperatively in the surgery day as total operation time and ischemic time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Maxillary Tumors</condition>
  <arm_group>
    <arm_group_label>FSF with CAD\CAM customized cutting guide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FSF without customized cutting guide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>maxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FSF with CAD\CAM customized cutting guide</intervention_name>
    <description>This began with the acquisition of a high-resolution CT scan of the patient's maxilla and scapula. The CT scan will be sent to the modeling company that produce 3D autoclavable models and cutting guides to be used during resection and scapular harvesting as well as a model of the final reconstructed maxilla.&#xD;
surgery will performed by two surgical teams one for tumor resection and the other harvesting the flap.&#xD;
access to the maxilla was obtained and the cutting guides were secured in the planned position; the cuts were completed. The scapular guides were secured to the harvested scapula to replicate the cuts that were planned previously.&#xD;
The scapula and plate will be fixed and pedicle anastomosis is performed. the operation then completed with soft tissue reconstruction.</description>
    <arm_group_label>FSF with CAD\CAM customized cutting guide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FSF without customized cutting guide</intervention_name>
    <description>This began with the acquisition of a high-resolution CT scan of the patient's maxilla .&#xD;
The C.T scan will be sent to the modeling company for planning three-dimensional model of the maxilla. autoclavable model will be prepared to be used during the workflow for plate reshaping to conforme the prices position of the maxilla.&#xD;
surgery will performed in a single step by two surgical teams, one for cervicofacial resection and the other for harvesting the flap.&#xD;
Resection-reconstruction then performed in aconventional surgical manner with microvascular anastomosis. finally the operation will be completed with soft tissue reconstruction as needed.</description>
    <arm_group_label>FSF without customized cutting guide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients affected by tumor involving Maxillary bone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having poor oncological prognosis&#xD;
&#xD;
          -  Patients with poor performance status together with other relative or absolute&#xD;
             vascular contraindication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammed S Al-wadeai, Phd. student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammed S Al-wadeai, Phd. student</last_name>
    <phone>00201122538653</phone>
    <email>alwadai20111@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculity of Dentistry-Cairo university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammed S Al-wadeai, Phd. student</last_name>
      <phone>00201122538653</phone>
      <email>alwadai20111@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Salah Mohammed Al-Wadeai</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>maxillary tumors resection\ reconstruction</keyword>
  <keyword>CAD\CAM</keyword>
  <keyword>osteotomy, cutting guide</keyword>
  <keyword>aesthetic</keyword>
  <keyword>operation time</keyword>
  <keyword>free scapular flap</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maxillary Neoplasms</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/NCT03757286
org study id: 654
nct id: NCT03757286
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare aesthetic results and operation time of Free Scapular flap
      with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects.
Maxillofacial defects create unique challenges for the reconstructive surgeon, often
      involving bony and soft tissue components of the midface. Surgical reconstruction following
      maxillectomy is currently a topic of interest for reconstructive head and neck surgeons.
      maxillary defects were reconstructed with maxillofacial prosthetics including obturation.
      While the latter is an effective reconstruction. Over the past two decades, there has been
      increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla.

      Scapular flap It is an excellent candidate for maxillectomy defects because of its unique
      feature, which is characterized by additional skin paddles or muscles. and can be harvested
      along with a part of the scapular bone for bony reconstruction

      Traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact
      planning, poor communication between the resective and reconstructive teams or surgical
      difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3D)
      defect without the help of any templates or surgical guides The advent of 3D modeling in head
      and neck reconstruction has allowed surgeons to improve upon functional and aesthetic
      outcomes, which are crucial to patient satisfaction and can be difficult to achieve in
      maxillectomy defects The cutting guides used or not used, however debate still present for
      its benefits and worth for patient and surgeon. current study to evaluate how such virtual
      planning with using of customized cutting guide is effective and worth for patient aesthetic
      and operation time.

      our priori-hypothesis is that utilization CAD/CAM assisted with customized osteotomy guide is
      not related to an altered result regarding aesthetic outcome and operation time in patient
      undergoing maxillary reconstruction using free scapular flap.

      In order to test this hypothesis, we will compare aesthetic outcome and operation time in
      group of patients receive FSF by CAD/CAM-assisted with customized osteotomy guide to results
      of another group of patients receive FSF but without customized osteotomy guide. only model
      will be performed as conventional method aiding in reshaping of reconstruction plate which is
      another well-established concept of management of maxillary defect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.
measure: Aesthetic
time frame: at least three months postoperative
description: aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to other side of maxilla.subjectively will be evaluated using VAS.
measure: operation time
time frame: intraoperative
description: operation time will be recorded intraoperatively in the surgery day as total operation time and ischemic time.
arm group label: FSF with CAD\CAM customized cutting guide
arm group type: Experimental
description: Maxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide.
arm group label: FSF without customized cutting guide
arm group type: Active Comparator
description: maxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla will be used.
intervention type: Procedure
intervention name: FSF with CAD\CAM customized cutting guide
description: This began with the acquisition of a high-resolution CT scan of the patient's maxilla and scapula. The CT scan will be sent to the modeling company that produce 3D autoclavable models and cutting guides to be used during resection and scapular harvesting as well as a model of the final reconstructed maxilla.
surgery will performed by two surgical teams one for tumor resection and the other harvesting the flap.
access to the maxilla was obtained and the cutting guides were secured in the planned position; the cuts were completed. The scapular guides were secured to the harvested scapula to replicate the cuts that were planned previously.
The scapula and plate will be fixed and pedicle anastomosis is performed. the operation then completed with soft tissue reconstruction.
arm group label: FSF with CAD\CAM customized cutting guide
intervention type: Procedure
intervention name: FSF without customized cutting guide
description: This began with the acquisition of a high-resolution CT scan of the patient's maxilla .
The C.T scan will be sent to the modeling company for planning three-dimensional model of the maxilla. autoclavable model will be prepared to be used during the workflow for plate reshaping to conforme the prices position of the maxilla.
surgery will performed in a single step by two surgical teams, one for cervicofacial resection and the other for harvesting the flap.
Resection-reconstruction then performed in aconventional surgical manner with microvascular anastomosis. finally the operation will be completed with soft tissue reconstruction as needed.
arm group label: FSF without customized cutting guide
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohammed S Al-wadeai, Phd. student
role: Principal Investigator
affiliation: Cairo University
last name: Mohammed S Al-wadeai, Phd. student
phone: 00201122538653
email: alwadai20111@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Salah Mohammed Al-Wadeai
investigator title: principal investigator
mesh term: Maxillary Neoplasms
sharing ipd: Undecided