<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/NCT03270618</url>
  </required_header>
  <id_info>
    <org_study_id>cmfs02</org_study_id>
    <nct_id>NCT03270618</nct_id>
  </id_info>
  <brief_title>Accuracy of a CAD/CAM Surgical Template for Mandible Distraction</brief_title>
  <official_title>Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <oversight_info>
    <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 was to assess the accuracy and clinical validation of virtual planning and&#xD;
      surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia&#xD;
      were enrolled. Virtual planning and simulation were performed on three-dimensional models.&#xD;
      Distraction was simulated on virtual model and the new morphology of the mandible was&#xD;
      predicted. The position and direction of the distractor was determined to achieve the optimal&#xD;
      morphology. The templates were designed based on virtual planning and manufactured using&#xD;
      three-dimensional printing technique. The template is designed to assist the surgeon to&#xD;
      perform the osteotomy and predrill the screw holes to guide the distractor position. The&#xD;
      outcome evaluation was completed by comparing planned outcomes with postoperative outcomes.&#xD;
      Linear and angular differences for the distractor was measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Linear differences of the distractor position</measure>
    <time_frame>within latency period (5-7 days after the surgery)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>angular differences of the distractor vector</measure>
    <time_frame>within latency period (5-7 days after the surgery)</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Facial Asymmetry</condition>
  <condition>Mandible; Hypoplasia, Unilateral Condylar</condition>
  <condition>Distraction of Bone</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CAD/CAM Surgical Template</intervention_name>
    <description>The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were scheduled to undergo mandibular DO via intraoral approach&#xD;
&#xD;
          -  Patients who were scheduled to undergo CT scan as a part of their diagnosis and&#xD;
             treatment&#xD;
&#xD;
          -  Patients who agreed to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients requiring more than one distractor of the mandible&#xD;
&#xD;
          -  Patients with mandible defect&#xD;
&#xD;
          -  Patients with previous mandibular trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xudong Wang</last_name>
    <role>Study Chair</role>
    <affiliation>Ninth People's Hospital, Shanghai Jiaotong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Biao Li, Master</last_name>
    <phone>15900561183</phone>
    <email>benleex@foxmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ninth People's Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Biao Li, Master</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Xudong Wang</investigator_full_name>
    <investigator_title>Director of the Department of Oral and Craniomaxillofacial Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diastasis, Bone</mesh_term>
    <mesh_term>Micrognathism</mesh_term>
    <mesh_term>Facial Asymmetry</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03270618
org study id: cmfs02
nct id: NCT03270618
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose was to assess the accuracy and clinical validation of virtual planning and
      surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia
      were enrolled. Virtual planning and simulation were performed on three-dimensional models.
      Distraction was simulated on virtual model and the new morphology of the mandible was
      predicted. The position and direction of the distractor was determined to achieve the optimal
      morphology. The templates were designed based on virtual planning and manufactured using
      three-dimensional printing technique. The template is designed to assist the surgeon to
      perform the osteotomy and predrill the screw holes to guide the distractor position. The
      outcome evaluation was completed by comparing planned outcomes with postoperative outcomes.
      Linear and angular differences for the distractor was measured.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Linear differences of the distractor position
time frame: within latency period (5-7 days after the surgery)
measure: angular differences of the distractor vector
time frame: within latency period (5-7 days after the surgery)
intervention type: Device
intervention name: CAD/CAM Surgical Template
description: The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position.
criteria: 
gender: All
minimum age: 6 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xudong Wang
role: Study Chair
affiliation: Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
last name: Biao Li, Master
phone: 15900561183
email: benleex@foxmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Xudong Wang
investigator title: Director of the Department of Oral and Craniomaxillofacial Surgery
mesh term: Diastasis, Bone
mesh term: Micrognathism
mesh term: Facial Asymmetry
sharing ipd: No