xml: <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/NCT06005467</url>
    </required_header>
    <id_info>
      <org_study_id>9793</org_study_id>
      <nct_id>NCT06005467</nct_id>
    </id_info>
    <brief_title>V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures</brief_title>
    <official_title>The Effect of (v) Shaped Plate on Occlusion and Condylar Position Compared to Champy Technique in Fixation of Mandibular Angle Fracture (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>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>
        assessing fixation of mandibular angle fracture using two different mini plates, the standard&#xD;
        champy technique and the new V shaped plate with comparing occlusion and condylar position&#xD;
        between the two plates.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The mandible is one of the most frequent bones of the face that is susceptible to fractures&#xD;
        because its prominent position, as it comes in the second place after nasal fractures .&#xD;
        Mostly, such fractures are a result of trauma caused by vehicle accidents, physical&#xD;
        altercations, industrial accidents, falls, and contact sports, males usually suffer from&#xD;
        mandibular fractures more than females.&#xD;
  &#xD;
        The angle of the mandible is the most frequent area of the mandible to be fractured after the&#xD;
        body, the reasons behind that is the presence of a third molar especially if it was impacted&#xD;
        one which weakens the region even more, another reason is the existence of a very thin cross&#xD;
        sectional area compared to the anterior parts of the mandible. Most common causes of&#xD;
        mandibular angle fractures are motor vehicle collisions and assaults or altercations.&#xD;
  &#xD;
        Therefore, the aim of this study is to evaluate a novel method which is using a (v) shaped&#xD;
        plate in fixation of mandibular angle fracture, The new (v) shaped plate have provided easy&#xD;
        reduction and stabilized fixation along both sides of the fracture, as it has two arms that&#xD;
        can be easily adjusted over the angle of the mandible covering both lines of osteosynthesis&#xD;
        along the superior border and lateral surface of the external oblique ridge using a single&#xD;
        plate.&#xD;
  &#xD;
        Although champy technique has been proven to be successful way for treating angle fractures&#xD;
        with low complication rates it covers only one line of osteosynthesis which is the superior&#xD;
        border of external oblique ridge unlike the (v) shaped plate.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
    </study_design_info>
    <primary_outcome>
      <measure>proper occlusion</measure>
      <time_frame>1 week- 3 months and 6 months</time_frame>
      <description>It's Clinically assessed outcome. Follow up will be carried out immediate post-operative (after1 week), 3months and after 6 months for general clinical assessment of the patient including proper occlusion.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>condylar position</measure>
      <time_frame>6 months</time_frame>
      <description>C.T scan will be taken post operatively after periods of 1week and 6 months to measure condylar position by specialized (software mimics) C.T superimposition.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Fractures, Bone</condition>
    <arm_group>
      <arm_group_label>V shaped plate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>champy technique</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>champy technique is one of the standard methods that are used in fixation of mandibular angle fractures by applying a mini-plate in the superior border of the external oblique ridge.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Open reduction and internal fixation of mandibular angle fracture using V shaped plate</intervention_name>
      <description>its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.</description>
      <arm_group_label>V shaped plate</arm_group_label>
      <arm_group_label>champy technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with unilateral angle fracture.&#xD;
  &#xD;
            2. Patients free from any systemic diseases that affect bone healing.&#xD;
  &#xD;
            3. No sex predilection.&#xD;
  &#xD;
            4. Age 18-50&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Comminuted angle fractures.&#xD;
  &#xD;
            2. Infected angle fracture.&#xD;
  &#xD;
            3. Bilateral angle fracture.&#xD;
  &#xD;
            4. Patients with any systemic diseases that affect bone healing.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rasha Tohamy, BSc.</last_name>
      <phone>01066534079</phone>
      <phone_ext>+2</phone_ext>
      <email>rasha.tohamy@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alaa Hassan, BSc.</last_name>
      <phone>01090101125</phone>
      <phone_ext>+2</phone_ext>
      <email>alaa.hassan@dentistry.cu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Dentistry , Cairo university</name>
        <address>
          <city>Cairo</city>
          <zip>12311</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Bhagat MJA, Durairaj D, Naganathan V, Nathiya B, Kumar GS, Mariam S. Application of Anatomically Designed 2-Dimensional V Plate in Management of Mandible Fracture: A Pilot Study. J Maxillofac Oral Surg. 2022 Dec;21(4):1363-1368. doi: 10.1007/s12663-021-01558-5. Epub 2021 Apr 23.</citation>
      <PMID>36896057</PMID>
    </reference>
    <reference>
      <citation>Lee JH. Treatment of Mandibular Angle Fractures. Arch Craniofac Surg. 2017 Jun;18(2):73-75. doi: 10.7181/acfs.2017.18.2.73. Epub 2017 Jun 26.</citation>
      <PMID>28913310</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Rasha Tohamy Abdelsattar Mohammed</investigator_full_name>
      <investigator_title>Master's degree candidate</investigator_title>
    </responsible_party>
    <keyword>champy</keyword>
    <keyword>angle fracture</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
  
  
text: 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/NCT06005467
  org study id: 9793
  nct id: NCT06005467
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  assessing fixation of mandibular angle fracture using two different mini plates, the standard
        champy technique and the new V shaped plate with comparing occlusion and condylar position
        between the two plates.
  The mandible is one of the most frequent bones of the face that is susceptible to fractures
        because its prominent position, as it comes in the second place after nasal fractures .
        Mostly, such fractures are a result of trauma caused by vehicle accidents, physical
        altercations, industrial accidents, falls, and contact sports, males usually suffer from
        mandibular fractures more than females.
  
        The angle of the mandible is the most frequent area of the mandible to be fractured after the
        body, the reasons behind that is the presence of a third molar especially if it was impacted
        one which weakens the region even more, another reason is the existence of a very thin cross
        sectional area compared to the anterior parts of the mandible. Most common causes of
        mandibular angle fractures are motor vehicle collisions and assaults or altercations.
  
        Therefore, the aim of this study is to evaluate a novel method which is using a (v) shaped
        plate in fixation of mandibular angle fracture, The new (v) shaped plate have provided easy
        reduction and stabilized fixation along both sides of the fracture, as it has two arms that
        can be easily adjusted over the angle of the mandible covering both lines of osteosynthesis
        along the superior border and lateral surface of the external oblique ridge using a single
        plate.
  
        Although champy technique has been proven to be successful way for treating angle fractures
        with low complication rates it covers only one line of osteosynthesis which is the superior
        border of external oblique ridge unlike the (v) shaped plate.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: proper occlusion
  time frame: 1 week- 3 months and 6 months
  description: It's Clinically assessed outcome. Follow up will be carried out immediate post-operative (after1 week), 3months and after 6 months for general clinical assessment of the patient including proper occlusion.
  measure: condylar position
  time frame: 6 months
  description: C.T scan will be taken post operatively after periods of 1week and 6 months to measure condylar position by specialized (software mimics) C.T superimposition.
  arm group label: V shaped plate
  arm group type: Experimental
  description: its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.
  arm group label: champy technique
  arm group type: Active Comparator
  description: champy technique is one of the standard methods that are used in fixation of mandibular angle fractures by applying a mini-plate in the superior border of the external oblique ridge.
  intervention type: Procedure
  intervention name: Open reduction and internal fixation of mandibular angle fracture using V shaped plate
  description: its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.
  arm group label: V shaped plate
  arm group label: champy technique
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rasha Tohamy, BSc.
  phone: 01066534079
  phone ext: +2
  email: rasha.tohamy@dentistry.cu.edu.eg
  last name: Alaa Hassan, BSc.
  phone: 01090101125
  phone ext: +2
  email: alaa.hassan@dentistry.cu.eg
  facility: 
  country: Egypt
  citation: Bhagat MJA, Durairaj D, Naganathan V, Nathiya B, Kumar GS, Mariam S. Application of Anatomically Designed 2-Dimensional V Plate in Management of Mandible Fracture: A Pilot Study. J Maxillofac Oral Surg. 2022 Dec;21(4):1363-1368. doi: 10.1007/s12663-021-01558-5. Epub 2021 Apr 23.
  PMID: 36896057
  citation: Lee JH. Treatment of Mandibular Angle Fractures. Arch Craniofac Surg. 2017 Jun;18(2):73-75. doi: 10.7181/acfs.2017.18.2.73. Epub 2017 Jun 26.
  PMID: 28913310
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Rasha Tohamy Abdelsattar Mohammed
  investigator title: Master's degree candidate
  mesh term: Fractures, Bone
  sharing ipd: No