<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/NCT03752554</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-10</org_study_id>
    <nct_id>NCT03752554</nct_id>
  </id_info>
  <brief_title>Assessment of Neurosensory Function Following Segmental Mandibular Resection.</brief_title>
  <official_title>Assessment of Neurosensory Function Following Segmental Mandibular Resection of Non-malignant Lesions With Inferior Alveolar Nerve Preservation: A Case Series 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study wInclusion criteria for this study will be as follows:&#xD;
&#xD;
        -  Age group: from 15 to 60 years old.&#xD;
&#xD;
        -  Patients with with non malignant mandibular neoplasms indicated for segmental resection.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Patients with malignant mandibular neoplasms.&#xD;
&#xD;
      All cases will undergo surgery under general anesthesia. The mandibular lesion will be&#xD;
      segmentally resected. The cuts will be performed with the aid of the prefabricated digital&#xD;
      template. The neurovascular bundle will be separated and protected. Then reconstruction will&#xD;
      be performed.&#xD;
&#xD;
      Postoperative patient evaluation:&#xD;
&#xD;
      Neurosensory examination:&#xD;
&#xD;
      Assessment of the inferior alveolar nerve function will be performed preoperatively, 2 and 12&#xD;
      weeks postoperatively through Trigeminal somatosensory evoked potential technique. Six months&#xD;
      postoperatively by CBCT for assessment of recurrence&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will include 10 patients complaining from non malignant mandibular lesions.&#xD;
      nopatients will be selected from the outpatient clinic of the Oral &amp; Maxillofacial Surgery&#xD;
      department, faculty of Dental Medicine Cairo University.&#xD;
&#xD;
      All the procedures will be explained for all patients before undergoing operation and&#xD;
      informed consent process will be taken, this study will be displayed to the research ethics&#xD;
      committee to obtain approval.&#xD;
&#xD;
      Inclusion criteria for this study will be as follows:&#xD;
&#xD;
        -  Age group: from 15 to 60 years old.&#xD;
&#xD;
        -  Patients with with non malignant mandibular neoplasms indicated for segmental resection.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Patients with malignant mandibular neoplasms. 1- Pre-operative phase&#xD;
&#xD;
      Patients will be subjected to:&#xD;
&#xD;
      Case history including personal data, medical, a-surgical and family history b-Clinical&#xD;
      examination c.Radiographic examination using orthopantogram, and computed tomography (CT)&#xD;
      Preoperative anesthesia assessment for fitness for general anesthesia.d Treatment planning&#xD;
      and fabrication of the digital template.e 2 -Operative phase All cases will undergo surgery&#xD;
      under general anesthesia. The mandibular lesion will be segmentally resected. The cuts will&#xD;
      be performed with the aid of the prefabricated digital template. The neurovascular bundle&#xD;
      will be separated and protected. Then reconstruction will be performed.&#xD;
&#xD;
      3-Postoperative care:&#xD;
&#xD;
      Postsurgical instructions and follow up:&#xD;
&#xD;
      Proper postoperative instructions will be given the patient, in addition to the postoperative&#xD;
      medications including antibiotics, corticosteroids and analgesics.&#xD;
&#xD;
      Postoperative patient evaluation:&#xD;
&#xD;
      Neurosensory examination:&#xD;
&#xD;
      Assessment of the inferior alveolar nerve function will be performed preoperatively, 2 and 12&#xD;
      weeks postoperatively through Trigeminal somatosensory evoked potential technique. Six months&#xD;
      postoperatively by CBCT for assessment of recurrence.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social&#xD;
      Sciences), version 21 (SPSS Inc. Chicago). The data will be compared using paired t-test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>measurement of nerve stimulation</measure>
    <time_frame>3 months</time_frame>
    <description>somatosensory evoked potential technique</description>
  </primary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Resection Cavity</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>segmental resection</intervention_name>
    <description>All cases will undergo surgery under general anesthesia. The mandibular lesion will be segmentally resected. The cuts will be performed with the aid of the prefabricated digital template. The neurovascular bundle will be separated and protected. Then reconstruction will be performed</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with non malignant mandibular lesions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  -Age group: from 15 to 60 years old.&#xD;
&#xD;
          -  Patients with with non malignant mandibular neoplasms indicated for segmental&#xD;
             resection..&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  -Patients with malignant mandibular neoplasms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ragia mo mounir, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>kaser elany cairo univeristy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>mahmoud mo shalash, researcher</last_name>
    <phone>01006151498</phone>
    <email>shalash_dentistry@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>adel h aboelftoh, ass prof</last_name>
    <phone>01018871899</phone>
    <email>aabouelfetouh@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Al Einy Cairo Univeristy</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ragia mo mounir, professor</last_name>
      <phone>01006600993</phone>
      <email>ragiamounir@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>adel h aboelftouh, ass prosf</last_name>
      <phone>01018871899</phone>
      <email>aabouelfetouh@dentistry.cu.edg.eg</email>
    </contact_backup>
    <investigator>
      <last_name>ragia mounir, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Preservation+of+the+inferior+alveolar+neurovascular+bundle+in+the+osteotomy+of+benign+lesions+of+the+mandible+using+a+digital+template.</url>
    <description>preservation of inferior alveolar nerve</description>
  </link>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>sherif awad</investigator_full_name>
    <investigator_title>assistant researcher in national research centre</investigator_title>
  </responsible_party>
  <keyword>segmental mandibular resection-IAN</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>international publishing</ipd_description>
  </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/NCT03752554
org study id: CEBD-CU-2018-11-10
nct id: NCT03752554
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study wInclusion criteria for this study will be as follows:

        -  Age group: from 15 to 60 years old.

        -  Patients with with non malignant mandibular neoplasms indicated for segmental resection.

      Exclusion criteria:

        -  Patients with malignant mandibular neoplasms.

      All cases will undergo surgery under general anesthesia. The mandibular lesion will be
      segmentally resected. The cuts will be performed with the aid of the prefabricated digital
      template. The neurovascular bundle will be separated and protected. Then reconstruction will
      be performed.

      Postoperative patient evaluation:

      Neurosensory examination:

      Assessment of the inferior alveolar nerve function will be performed preoperatively, 2 and 12
      weeks postoperatively through Trigeminal somatosensory evoked potential technique. Six months
      postoperatively by CBCT for assessment of recurrence
This study will include 10 patients complaining from non malignant mandibular lesions.
      nopatients will be selected from the outpatient clinic of the Oral & Maxillofacial Surgery
      department, faculty of Dental Medicine Cairo University.

      All the procedures will be explained for all patients before undergoing operation and
      informed consent process will be taken, this study will be displayed to the research ethics
      committee to obtain approval.

      Inclusion criteria for this study will be as follows:

        -  Age group: from 15 to 60 years old.

        -  Patients with with non malignant mandibular neoplasms indicated for segmental resection.

      Exclusion criteria:

        -  Patients with malignant mandibular neoplasms. 1- Pre-operative phase

      Patients will be subjected to:

      Case history including personal data, medical, a-surgical and family history b-Clinical
      examination c.Radiographic examination using orthopantogram, and computed tomography (CT)
      Preoperative anesthesia assessment for fitness for general anesthesia.d Treatment planning
      and fabrication of the digital template.e 2 -Operative phase All cases will undergo surgery
      under general anesthesia. The mandibular lesion will be segmentally resected. The cuts will
      be performed with the aid of the prefabricated digital template. The neurovascular bundle
      will be separated and protected. Then reconstruction will be performed.

      3-Postoperative care:

      Postsurgical instructions and follow up:

      Proper postoperative instructions will be given the patient, in addition to the postoperative
      medications including antibiotics, corticosteroids and analgesics.

      Postoperative patient evaluation:

      Neurosensory examination:

      Assessment of the inferior alveolar nerve function will be performed preoperatively, 2 and 12
      weeks postoperatively through Trigeminal somatosensory evoked potential technique. Six months
      postoperatively by CBCT for assessment of recurrence.

      Statistical analysis:

      Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social
      Sciences), version 21 (SPSS Inc. Chicago). The data will be compared using paired t-test.
observational model: Other
time perspective: Prospective
measure: measurement of nerve stimulation
time frame: 3 months
description: somatosensory evoked potential technique
intervention type: Procedure
intervention name: segmental resection
description: All cases will undergo surgery under general anesthesia. The mandibular lesion will be segmentally resected. The cuts will be performed with the aid of the prefabricated digital template. The neurovascular bundle will be separated and protected. Then reconstruction will be performed
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ragia mo mounir, professor
role: Principal Investigator
affiliation: kaser elany cairo univeristy
last name: mahmoud mo shalash, researcher
phone: 01006151498
email: shalash_dentistry@gmail.com
last name: adel h aboelftoh, ass prof
phone: 01018871899
email: aabouelfetouh@dentistry.cu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Preservation+of+the+inferior+alveolar+neurovascular+bundle+in+the+osteotomy+of+benign+lesions+of+the+mandible+using+a+digital+template.
description: preservation of inferior alveolar nerve
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: sherif awad
investigator title: assistant researcher in national research centre
sharing ipd: Undecided
ipd description: international publishing