<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/NCT03757273</url>
  </required_header>
  <id_info>
    <org_study_id>653</org_study_id>
    <nct_id>NCT03757273</nct_id>
  </id_info>
  <brief_title>Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using FFF With and Without CAD/CAM Customized Cutting Guide</brief_title>
  <official_title>Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular 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 purpose of this study is to compare Aesthetic results and operation time of free fibular&#xD;
      flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular&#xD;
      defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral and maxillofacial tumors posing an important fact as a demanding challenge for surgeons&#xD;
      causing face disfigurement which require post-ablation reconstruction. One of the most&#xD;
      challenging procedure facing reconstructive surgeons lies in mandibular defects after tumor&#xD;
      resection causing facial disharmony affecting aesthetics and function.&#xD;
&#xD;
      Free flaps are considered the gold standard for the reconstruction during oncologic surgery&#xD;
      combining a high success rate with low donor site morbidity. Various techniques have been&#xD;
      practiced and performed in mandibular defect reconstruction. Hidalgo introduced the fibular&#xD;
      graft as an option, offering many Assorted advantages: as it provides a sufficient source for&#xD;
      bone and soft tissue harvesting; long reliable vascular pedicle; moreover, only minor donor&#xD;
      site morbidity may be involved and flap harvesting require no patient reposition.&#xD;
&#xD;
      Mandibular reconstruction using FFF has become the gold standard. However, flap contouring&#xD;
      remain an issue and imprecise with inconvenient or suboptimal final results regrading&#xD;
      aesthetic and even more consuming time and efforts owing to poor planning when performed&#xD;
      traditionally. Recently, with newly introduced technology and virtual planning, the process&#xD;
      has become more uniform and reproducible thus enhancing final outcome improving patient life.&#xD;
&#xD;
      Prefabricated cutting guides may be used may be not, however it still in debate regarding its&#xD;
      benefits and worth for patient and surgeon. believing that ability of CAD/CAM technology to&#xD;
      achieve Aesthetic and operation time improvement with more detailed evaluation in patients&#xD;
      undergoing mandibular reconstruction using free fibular flap with CAD/CAM customized cutting&#xD;
      guide.&#xD;
&#xD;
      Our priori-hypothesis is that utilization of CAD/CAM-assisted with customized osteotomy guide&#xD;
      is not related to an altered result regarding aesthetic outcome and operation time in patient&#xD;
      undergoing mandibular reconstruction using free fibular flap. In order to test this&#xD;
      hypothesis, we will compare aesthetic outcome and operation time in group of patients receive&#xD;
      FFF by CAD/CAM-assisted with customized osteotomy guide to the results of another group of&#xD;
      patients receive FFF but without customized osteotomy guide. only model will be performed as&#xD;
      conventional method helping in pre-shaping of reconstruction plate which is another&#xD;
      well-established concept of management of mandibular 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 participant and the investigators, neither the investigator nor the participant can be blinded. But, the assessor and the statistician will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Aesthetic</measure>
    <time_frame>at least three months post operative</time_frame>
    <description>Aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to the other side of the mandible. 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 ischemia time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Mandibular Tumors</condition>
  <arm_group>
    <arm_group_label>FFF with CAD/CAM customized cutting guide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FFF without customized cutting guide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FFF with CAD/CAM customized cutting guide</intervention_name>
    <description>This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton and lower legs. the CT scan will be sent to the modeling company for producing autoclavable 3D models and cutting guides of the mandible and fibula to be used during the workflow as well as a model of the final reconstructed mandible. Surgery will be performed by two surgical teams, one for cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, osteotomy guides secured; cuts then accomplished as planned virtually. fibular flap is harvested and cutting guides secured to replicate osteotomies and reshaping as planned to conform with remaining mandible. fixation and pedicle anastomosis is performed. Finally, the operation completed with soft tissue reconstruction.</description>
    <arm_group_label>FFF with CAD/CAM customized cutting guide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FFF without customized cutting guide</intervention_name>
    <description>This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton. the C.T scan will be sent to the modeling company for planning three-dimensional model of the mandible. autoclavable model will be prepared for mandible to be used during the workflow for plate reshaping and positioning to conform with the remaining mandible.&#xD;
Surgery will be performed by two surgical teams, one in charge of cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, and resection/ reconstruction then performed in conventional surgical manner with microvascular anastomosis. Finally, the operation will be completed with soft tissue reconstruction.</description>
    <arm_group_label>FFF without customized cutting guide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients affected by tumor involving Mandibular 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;
&#xD;
          -  Patients require marginal resection or with bilateral fibular fracture&#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 E Al-Sabahi, Phd. student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammed E Al-Sabahi, Phd. student</last_name>
    <phone>00201111960834</phone>
    <email>mea.sabahi2014@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Dentistry- Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammed E Al-Sabahi, Phd. student</last_name>
      <phone>00201111960834</phone>
      <email>mea.sabahi2014@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 Esmail Abdullah Al-Sabahi</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Mandibular tumors resection/reconstruction</keyword>
  <keyword>CAD/CAM</keyword>
  <keyword>Osteotomy, Cutting guide</keyword>
  <keyword>Aesthetic</keyword>
  <keyword>Operation time</keyword>
  <keyword>Free fibular flap</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mandibular 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/NCT03757273
org study id: 653
nct id: NCT03757273
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare Aesthetic results and operation time of free fibular
      flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular
      defects.
Oral and maxillofacial tumors posing an important fact as a demanding challenge for surgeons
      causing face disfigurement which require post-ablation reconstruction. One of the most
      challenging procedure facing reconstructive surgeons lies in mandibular defects after tumor
      resection causing facial disharmony affecting aesthetics and function.

      Free flaps are considered the gold standard for the reconstruction during oncologic surgery
      combining a high success rate with low donor site morbidity. Various techniques have been
      practiced and performed in mandibular defect reconstruction. Hidalgo introduced the fibular
      graft as an option, offering many Assorted advantages: as it provides a sufficient source for
      bone and soft tissue harvesting; long reliable vascular pedicle; moreover, only minor donor
      site morbidity may be involved and flap harvesting require no patient reposition.

      Mandibular reconstruction using FFF has become the gold standard. However, flap contouring
      remain an issue and imprecise with inconvenient or suboptimal final results regrading
      aesthetic and even more consuming time and efforts owing to poor planning when performed
      traditionally. Recently, with newly introduced technology and virtual planning, the process
      has become more uniform and reproducible thus enhancing final outcome improving patient life.

      Prefabricated cutting guides may be used may be not, however it still in debate regarding its
      benefits and worth for patient and surgeon. believing that ability of CAD/CAM technology to
      achieve Aesthetic and operation time improvement with more detailed evaluation in patients
      undergoing mandibular reconstruction using free fibular flap with CAD/CAM customized cutting
      guide.

      Our priori-hypothesis is that utilization of CAD/CAM-assisted with customized osteotomy guide
      is not related to an altered result regarding aesthetic outcome and operation time in patient
      undergoing mandibular reconstruction using free fibular flap. In order to test this
      hypothesis, we will compare aesthetic outcome and operation time in group of patients receive
      FFF by CAD/CAM-assisted with customized osteotomy guide to the results of another group of
      patients receive FFF but without customized osteotomy guide. only model will be performed as
      conventional method helping in pre-shaping of reconstruction plate which is another
      well-established concept of management of mandibular 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 participant and the investigators, neither the investigator nor the participant can be blinded. But, the assessor and the statistician will be blinded.
measure: Aesthetic
time frame: at least three months post operative
description: Aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to the other side of the mandible. 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 ischemia time.
arm group label: FFF with CAD/CAM customized cutting guide
arm group type: Experimental
description: Mandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide.
arm group label: FFF without customized cutting guide
arm group type: Active Comparator
description: Mandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible will be used.
intervention type: Procedure
intervention name: FFF with CAD/CAM customized cutting guide
description: This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton and lower legs. the CT scan will be sent to the modeling company for producing autoclavable 3D models and cutting guides of the mandible and fibula to be used during the workflow as well as a model of the final reconstructed mandible. Surgery will be performed by two surgical teams, one for cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, osteotomy guides secured; cuts then accomplished as planned virtually. fibular flap is harvested and cutting guides secured to replicate osteotomies and reshaping as planned to conform with remaining mandible. fixation and pedicle anastomosis is performed. Finally, the operation completed with soft tissue reconstruction.
arm group label: FFF with CAD/CAM customized cutting guide
intervention type: Procedure
intervention name: FFF without customized cutting guide
description: This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton. the C.T scan will be sent to the modeling company for planning three-dimensional model of the mandible. autoclavable model will be prepared for mandible to be used during the workflow for plate reshaping and positioning to conform with the remaining mandible.
Surgery will be performed by two surgical teams, one in charge of cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, and resection/ reconstruction then performed in conventional surgical manner with microvascular anastomosis. Finally, the operation will be completed with soft tissue reconstruction.
arm group label: FFF without customized cutting guide
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohammed E Al-Sabahi, Phd. student
role: Principal Investigator
affiliation: Cairo University
last name: Mohammed E Al-Sabahi, Phd. student
phone: 00201111960834
email: mea.sabahi2014@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Esmail Abdullah Al-Sabahi
investigator title: Principal investigator
mesh term: Mandibular Neoplasms
sharing ipd: Undecided