<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/NCT03761524</url>
  </required_header>
  <id_info>
    <org_study_id>543</org_study_id>
    <nct_id>NCT03761524</nct_id>
  </id_info>
  <brief_title>Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture</brief_title>
  <official_title>Evaluation of the Effect of Customized V Plate Fixation Versus a Conventional Superior -Inferior Miniplates Fixation of Mandibular Angle Fracture on Mouth Opening and Radiographical Parameters Randomized 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 to evaluate the effect of customized V pattern plate fixation versus a&#xD;
      conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth&#xD;
      opening and radio graphical parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of&#xD;
      all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest&#xD;
      postoperative complications among all mandibular fractures, and the loosening of screws and&#xD;
      fracturing of plates are main reasons for the complications.The most widely used treatment&#xD;
      modality for mandibular angle fracture is the use of one miniplate fixation ,The other one&#xD;
      uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment&#xD;
      which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the&#xD;
      inferior border of the mandible which corresponds to the compression band of the mandible,&#xD;
      however, based on recent experimental and clinical studies, the stability provided by the&#xD;
      miniplate fixation of mandibular angle fractures has become a point of contention among&#xD;
      surgeons .In order to decrease the need for plate removal, reduce the operative time and&#xD;
      improve the stability of the fixation system, a customized V pattern plate design is an&#xD;
      appropriate plate structure for fractured mandible using the minimum output values for stress&#xD;
      of plate and displacement of bony segments to seek maximum reduction volume on an original&#xD;
      plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial&#xD;
      swelling, maximal mouth opening, sensory function, and surgical wound ,these should be&#xD;
      evaluated postoperatively ,radio graphical evaluation is also an important parameter to&#xD;
      assess adequate reduction of the fractured segments .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">August 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>Mouth Opening</measure>
    <time_frame>Every week for 1 month ,3 months and 6 months postoperative</time_frame>
    <description>Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographical parameters</measure>
    <time_frame>At 3 and 6 months postoperatively</time_frame>
    <description>Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occlusion</measure>
    <time_frame>immediate postoperative day</time_frame>
    <description>Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Mandibular Fractures</condition>
  <arm_group>
    <arm_group_label>Customized V plate fixation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional miniplates fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional superior-inferior miniplates fixation of mandibular angle fixation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Customized V plate fixation</intervention_name>
    <description>(CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate .</description>
    <arm_group_label>Customized V plate fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional miniplates fixation</intervention_name>
    <description>Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture.</description>
    <arm_group_label>Conventional miniplates fixation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with at least a unilateral unfavorable angle fracture indicated for Open&#xD;
             reduction internal fixation alone or in combination with fracture elsewhere in the&#xD;
             mandible or midrace.&#xD;
&#xD;
          -  Patients should be free from any systemic disease that may affect normal healing of&#xD;
             bone, and predictable outcome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic disease (may affect normal healing).&#xD;
&#xD;
          -  Patients with old and/or malunited fractures (affect accuracy of reduction of the&#xD;
             fractured segments).&#xD;
&#xD;
          -  Patients whom cannot tolerate follow up intervals (affect accuracy of study results).&#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>Hiba O Saleh, Phd.student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hiba O Saleh, Phd.student</last_name>
    <phone>00201010389391</phone>
    <email>dr.hiba2013@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Dentistry-Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>11599</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hiba Obad Saleh Saeed</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Angle fracture</keyword>
  <keyword>superior-inferior plate fixation</keyword>
  <keyword>custom made plate fixation</keyword>
  <keyword>postoperative complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mandibular Fractures</mesh_term>
    <mesh_term>Fractures, Bone</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/NCT03761524
org study id: 543
nct id: NCT03761524
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study to evaluate the effect of customized V pattern plate fixation versus a
      conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth
      opening and radio graphical parameters.
The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of
      all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest
      postoperative complications among all mandibular fractures, and the loosening of screws and
      fracturing of plates are main reasons for the complications.The most widely used treatment
      modality for mandibular angle fracture is the use of one miniplate fixation ,The other one
      uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment
      which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the
      inferior border of the mandible which corresponds to the compression band of the mandible,
      however, based on recent experimental and clinical studies, the stability provided by the
      miniplate fixation of mandibular angle fractures has become a point of contention among
      surgeons .In order to decrease the need for plate removal, reduce the operative time and
      improve the stability of the fixation system, a customized V pattern plate design is an
      appropriate plate structure for fractured mandible using the minimum output values for stress
      of plate and displacement of bony segments to seek maximum reduction volume on an original
      plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial
      swelling, maximal mouth opening, sensory function, and surgical wound ,these should be
      evaluated postoperatively ,radio graphical evaluation is also an important parameter to
      assess adequate reduction of the fractured segments .
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: Mouth Opening
time frame: Every week for 1 month ,3 months and 6 months postoperative
description: Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm
measure: Radiographical parameters
time frame: At 3 and 6 months postoperatively
description: Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean
measure: Occlusion
time frame: immediate postoperative day
description: Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion
arm group label: Customized V plate fixation
arm group type: Experimental
description: Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate
arm group label: Conventional miniplates fixation
arm group type: Active Comparator
description: Conventional superior-inferior miniplates fixation of mandibular angle fixation
intervention type: Procedure
intervention name: Customized V plate fixation
description: (CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate .
arm group label: Customized V plate fixation
intervention type: Procedure
intervention name: Conventional miniplates fixation
description: Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture.
arm group label: Conventional miniplates fixation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hiba O Saleh, Phd.student
role: Principal Investigator
affiliation: Cairo University
last name: Hiba O Saleh, Phd.student
phone: 00201010389391
email: dr.hiba2013@yahoo.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hiba Obad Saleh Saeed
investigator title: Principle Investigator
mesh term: Mandibular Fractures
mesh term: Fractures, Bone
sharing ipd: No