<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/NCT04443998</url>
  </required_header>
  <id_info>
    <org_study_id>Mandibular fracture reduction</org_study_id>
    <nct_id>NCT04443998</nct_id>
  </id_info>
  <brief_title>Mandibular Fracture Reduction Using Bone Reduction Forceps</brief_title>
  <official_title>Evaluation of Bone Reduction Forceps in Reducing Mandibular Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hams Hamed Abdelrahman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      Different methods have been used in reducing mandibular fractures. Bone reduction forceps&#xD;
      provides precise reduction and stabilize mandibular fracture segments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate clinically and radiographically the effect of using bone&#xD;
      reduction forceps in the reduction of isolated mandibular fractures.&#xD;
&#xD;
      10 patients complaining of isolated mandibular fractures in need of open reduction and&#xD;
      internal fixation underwent reduction using bone reduction forceps.&#xD;
&#xD;
      The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively.&#xD;
      Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and&#xD;
      cone-beam computed tomography (CBCT) will be done after 3 and 6 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 16, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 18, 2020</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>Change in radiodensitometric measurements</measure>
    <time_frame>at 3rd, 6th months</time_frame>
    <description>cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in maximal mouth opening</measure>
    <time_frame>1 week, 2 weeks, 1 month, 6 weeks, and 3 months</time_frame>
    <description>maximal interincisal opening between maxillary and mandibular central incisors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in occlusion</measure>
    <time_frame>1 week, 2 weeks, 1 month, 6 weeks, and 3 months</time_frame>
    <description>Any occlusal disturbance including open bite or improper tooth contact will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in pain level</measure>
    <time_frame>1 week, 2 weeks, 1 month, 6 weeks, and 3 months</time_frame>
    <description>Pain: will be measured on Visual Analogue Scale (VAS). The patients will be asked to rate their postoperative pain on a 4-point scale (0= none, 1= slight, 2= moderate, 3- severe)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Mandibular Fractures</condition>
  <arm_group>
    <arm_group_label>Bone reduction forceps</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bone reducion forceps</intervention_name>
    <description>Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction</description>
    <arm_group_label>Bone reduction forceps</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Adult patients aged from 20 to 45 years will be included.&#xD;
&#xD;
          -  Patients suffered from recent and uninfected.&#xD;
&#xD;
          -  Patients with isolated mandibular fractures.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Medically compromised patients that will be not fit for surgery.&#xD;
&#xD;
          -  Edentulous patients.&#xD;
&#xD;
          -  Non-displaced&#xD;
&#xD;
          -  Comminuted fracture with bone loss&#xD;
&#xD;
          -  Old fracture, more than 3 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt</name>
      <address>
        <city>Alexandria</city>
        <state>Azarita</state>
        <zip>00203</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT04443998
org study id: Mandibular fracture reduction
nct id: NCT04443998
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Different methods have been used in reducing mandibular fractures. Bone reduction forceps
      provides precise reduction and stabilize mandibular fracture segments.
The aim of this study is to evaluate clinically and radiographically the effect of using bone
      reduction forceps in the reduction of isolated mandibular fractures.

      10 patients complaining of isolated mandibular fractures in need of open reduction and
      internal fixation underwent reduction using bone reduction forceps.

      The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively.
      Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and
      cone-beam computed tomography (CBCT) will be done after 3 and 6 months
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in radiodensitometric measurements
time frame: at 3rd, 6th months
description: cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture
measure: change in maximal mouth opening
time frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
description: maximal interincisal opening between maxillary and mandibular central incisors.
measure: change in occlusion
time frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
description: Any occlusal disturbance including open bite or improper tooth contact will be recorded
measure: change in pain level
time frame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
description: Pain: will be measured on Visual Analogue Scale (VAS). The patients will be asked to rate their postoperative pain on a 4-point scale (0= none, 1= slight, 2= moderate, 3- severe)
arm group label: Bone reduction forceps
arm group type: Experimental
intervention type: Device
intervention name: Bone reducion forceps
description: Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction
arm group label: Bone reduction forceps
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Alexandria University
investigator full name: Hams Hamed Abdelrahman
investigator title: Assistant lecturer
mesh term: Mandibular Fractures
mesh term: Fractures, Bone