<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/NCT03839368</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2019-02-03</org_study_id>
    <nct_id>NCT03839368</nct_id>
  </id_info>
  <brief_title>Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates</brief_title>
  <official_title>Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Conventional Miniplates: 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>
      In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable&#xD;
      fixation than two conventional miniplates? Many studies have been conducted to compare&#xD;
      between different techniques of fixation used in angle fracture fixation. The driving force&#xD;
      behind this study was to design a new plate that would overcome the disadvantages of the&#xD;
      other plating techniques but has the advantages &amp; simplicity of the Champy technique (simple&#xD;
      intraoral approach and few major complications). This new miniplate gives more biomechanical&#xD;
      stability than the conventional Champy plate. More over the placement of a 3D miniplate or&#xD;
      two separate miniplates for fixing angle fractures is more difficult and mostly will require&#xD;
      a transbuccal approach , with increased surgical trauma, longer operation time unlike the new&#xD;
      plate that could provide the clinician with a simple and reliable solution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the past two decades, rigid internal fixation with miniplate has become the standard&#xD;
      treatment modality in the management of mandibular fracture.&#xD;
&#xD;
      The optimal management of mandibular angle fractures remains controversial, thus continuous&#xD;
      experimental &amp; clinical studies are being conducted to determine the best miniplate design&#xD;
      which will provide the best postoperative stability &amp; resistance to mechanical function.&#xD;
&#xD;
      Since Michelet et al.&amp; Champy et al. recommended the use of a single (4-6 holes) monocortical&#xD;
      plate , it become an acceptable method for angle fractures fixation.&#xD;
&#xD;
      Several surgeons have documented low complication rates with (Champy technique).But,&#xD;
      according to the most recent experimental &amp; clinical studies, the stability provided by the&#xD;
      miniplate fixation has become a point of debate among surgeons.Many researchers have argued&#xD;
      that internal fixation with a passive miniplate along the external oblique line, following&#xD;
      Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a&#xD;
      failure of osteosynthesis &amp; gap at inferior border of the mandible.And that pushed researches&#xD;
      to conduct more studies to evaluate many plate &amp; screw systems and even suggest new designs&#xD;
      for better stable postoperative results.&#xD;
&#xD;
      In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one&#xD;
      straight section and two lateral extensions. The straight section of this new design, which&#xD;
      has four holes, was adapted to the superior border of the external oblique ridge &amp; provides&#xD;
      similar advantages to the Champy technique (an intraoral approach, a single miniplate, &amp; the&#xD;
      use of monocortical screws) .And the two lateral extensions, with one hole each, were then&#xD;
      bent over to adapt to the buccal cortex of the ascending ramus along the external oblique&#xD;
      ridge to resist lateral &amp; torsional forces.&#xD;
&#xD;
      Fresh, frozen cadavers of 15 healthy sheep were obtained for this study, sheep were used in&#xD;
      this study owing to the similarities in size &amp; thickness to the human mandible. All of the&#xD;
      mandibles were stripped of their soft tissues &amp; sectioned through the midline, between the&#xD;
      central incisors. 30 hemimandibles were randomly divided into two groups , these groups were&#xD;
      then fixed with two different plating techniques (the new design &amp; one conventional&#xD;
      miniplates). And they were all examined for stability and resistance to mechanical forces&#xD;
      (vertical, lateral, or tensile).&#xD;
&#xD;
      The driving force behind this study was to design a new plate that would overcome the&#xD;
      disadvantages of the other plating techniques but has the advantages &amp; simplicity of the&#xD;
      Champy technique (simple intraoral approach and few major complications). This new miniplate&#xD;
      gives more biomechanical stability than the conventional Champy plate. These findings are&#xD;
      correlated to those of in vitro biomechanical study done by Alkan et al. that showed that&#xD;
      Champy technique has less favourable biomechanical behaviour than biplanar fixation and 3D&#xD;
      strut plate. In addition the new plate provide greater stability when subjected to lateral&#xD;
      displacing forces.&#xD;
&#xD;
      More over the placement of a 3D miniplate or two separate miniplates for fixing angle&#xD;
      fractures is more difficult and mostly will require a transbuccal approach , with increased&#xD;
      surgical trauma, longer operation time unlike the new plate that could provide the clinician&#xD;
      with a simple and reliable solution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 2020</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">April 11, 2020</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>
    <intervention_model_description>Randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Cards will have sequential numbers one number for each card then these cards will be placed within opaque sealed envelopes. Then these envelops will be placed in a container (box), each participant will grasp one envelope the day of procedure.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stability of angle fracture fixation</measure>
    <time_frame>3 months</time_frame>
    <description>Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT &amp; after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique.&#xD;
Bone density will be measured by Hounsfield unit at fracture site immediate postoperative &amp; after 3 months using F.B.CT.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Mandible Fracture</condition>
  <arm_group>
    <arm_group_label>K plate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fixation of angle fracture using K plate versus two miniplates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional two miniplates</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>fixation of angle fracture using K plate versus two miniplates</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fixation of angle fracture</intervention_name>
    <description>open reduction and internal fixation of angle fracture</description>
    <arm_group_label>Conventional two miniplates</arm_group_label>
    <arm_group_label>K plate</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 disease &amp; bone metabolism diseases.&#xD;
&#xD;
          3. No sex predilection&#xD;
&#xD;
          4. Age range ( 15-70)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Comminuted fragmented &amp; infected angle fractures.&#xD;
&#xD;
          2. Bilateral angle fracture.&#xD;
&#xD;
          3. Systemic diseases.&#xD;
&#xD;
          4. bone metabolism diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hagar Mohamed, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hagar A Mohamed, BDS</last_name>
    <phone>01016799911</phone>
    <email>hagar_elsherif92@yahoo.com</email>
  </overall_contact>
  <reference>
    <citation>Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.</citation>
    <PMID>24582290</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>June 1, 2019</last_update_submitted>
  <last_update_submitted_qc>June 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hagar Mahmoud Ahmed Mohamed</investigator_full_name>
    <investigator_title>Resident of Oral and Maxillofacial Surgery - Nasser Institute Hospital for research &amp; treatment / Master Candidate of Oral &amp; Maxillofacial surgery, Cairo University</investigator_title>
  </responsible_party>
  <keyword>angle fracture</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/NCT03839368
org study id: CEBD-CU-2019-02-03
nct id: NCT03839368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable
      fixation than two conventional miniplates? Many studies have been conducted to compare
      between different techniques of fixation used in angle fracture fixation. The driving force
      behind this study was to design a new plate that would overcome the disadvantages of the
      other plating techniques but has the advantages & simplicity of the Champy technique (simple
      intraoral approach and few major complications). This new miniplate gives more biomechanical
      stability than the conventional Champy plate. More over the placement of a 3D miniplate or
      two separate miniplates for fixing angle fractures is more difficult and mostly will require
      a transbuccal approach , with increased surgical trauma, longer operation time unlike the new
      plate that could provide the clinician with a simple and reliable solution.
In the past two decades, rigid internal fixation with miniplate has become the standard
      treatment modality in the management of mandibular fracture.

      The optimal management of mandibular angle fractures remains controversial, thus continuous
      experimental & clinical studies are being conducted to determine the best miniplate design
      which will provide the best postoperative stability & resistance to mechanical function.

      Since Michelet et al.& Champy et al. recommended the use of a single (4-6 holes) monocortical
      plate , it become an acceptable method for angle fractures fixation.

      Several surgeons have documented low complication rates with (Champy technique).But,
      according to the most recent experimental & clinical studies, the stability provided by the
      miniplate fixation has become a point of debate among surgeons.Many researchers have argued
      that internal fixation with a passive miniplate along the external oblique line, following
      Champy's ideal osteosynthesis line principle, produces a tension effect that may yield a
      failure of osteosynthesis & gap at inferior border of the mandible.And that pushed researches
      to conduct more studies to evaluate many plate & screw systems and even suggest new designs
      for better stable postoperative results.

      In 2014, B.T.Suer et al, designed a new noncompression 3D miniplates , basically it has one
      straight section and two lateral extensions. The straight section of this new design, which
      has four holes, was adapted to the superior border of the external oblique ridge & provides
      similar advantages to the Champy technique (an intraoral approach, a single miniplate, & the
      use of monocortical screws) .And the two lateral extensions, with one hole each, were then
      bent over to adapt to the buccal cortex of the ascending ramus along the external oblique
      ridge to resist lateral & torsional forces.

      Fresh, frozen cadavers of 15 healthy sheep were obtained for this study, sheep were used in
      this study owing to the similarities in size & thickness to the human mandible. All of the
      mandibles were stripped of their soft tissues & sectioned through the midline, between the
      central incisors. 30 hemimandibles were randomly divided into two groups , these groups were
      then fixed with two different plating techniques (the new design & one conventional
      miniplates). And they were all examined for stability and resistance to mechanical forces
      (vertical, lateral, or tensile).

      The driving force behind this study was to design a new plate that would overcome the
      disadvantages of the other plating techniques but has the advantages & simplicity of the
      Champy technique (simple intraoral approach and few major complications). This new miniplate
      gives more biomechanical stability than the conventional Champy plate. These findings are
      correlated to those of in vitro biomechanical study done by Alkan et al. that showed that
      Champy technique has less favourable biomechanical behaviour than biplanar fixation and 3D
      strut plate. In addition the new plate provide greater stability when subjected to lateral
      displacing forces.

      More over the placement of a 3D miniplate or two separate miniplates for fixing angle
      fractures is more difficult and mostly will require a transbuccal approach , with increased
      surgical trauma, longer operation time unlike the new plate that could provide the clinician
      with a simple and reliable solution.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized
primary purpose: Treatment
masking: Single (Participant)
masking description: Cards will have sequential numbers one number for each card then these cards will be placed within opaque sealed envelopes. Then these envelops will be placed in a container (box), each participant will grasp one envelope the day of procedure.
measure: Stability of angle fracture fixation
time frame: 3 months
description: Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT & after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique.
Bone density will be measured by Hounsfield unit at fracture site immediate postoperative & after 3 months using F.B.CT.
arm group label: K plate
arm group type: Experimental
description: fixation of angle fracture using K plate versus two miniplates
arm group label: Conventional two miniplates
arm group type: Active Comparator
description: fixation of angle fracture using K plate versus two miniplates
intervention type: Procedure
intervention name: fixation of angle fracture
description: open reduction and internal fixation of angle fracture
arm group label: Conventional two miniplates
arm group label: K plate
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hagar Mohamed, BDS
role: Principal Investigator
affiliation: Cairo University
last name: Hagar A Mohamed, BDS
phone: 01016799911
email: hagar_elsherif92@yahoo.com
citation: Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.
PMID: 24582290
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hagar Mahmoud Ahmed Mohamed
investigator title: Resident of Oral and Maxillofacial Surgery - Nasser Institute Hospital for research & treatment / Master Candidate of Oral & Maxillofacial surgery, Cairo University
mesh term: Mandibular Fractures
mesh term: Fractures, Bone
sharing ipd: No