<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/NCT03752944</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-19</org_study_id>
    <nct_id>NCT03752944</nct_id>
  </id_info>
  <brief_title>Comparison Between Prebent &amp; Miniplates in Fixation of Lefort I Osteotomty in Maxillary Advancement.</brief_title>
  <official_title>Stability of Maxillary Advancement by Lefort I Osteotomy in Patients With Retruded Maxilla Fixed With Two Prebent Plates Versus Four Miniplates. (Randomised 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 retruded maxilla ,Will the use of two prebent plates produce more stable&#xD;
      results postoperatively in fixation of Le Fort I osteotomy in maxillary advancement than&#xD;
      conventional four minplates ? Many studies have been conducted to compare between the two&#xD;
      plates and these studies showed that the prebent plate, the plate is not excessively twisted&#xD;
      so that it can be adapted passively leading to less changes in the property of the material&#xD;
      ,increased titanium contact surface to the bone leading to better force distribution&#xD;
      resulting in better rigid fixation as no stresses will be transmitted from the plate to the&#xD;
      bone leading to faster bone healing and consequently better long term postoperative&#xD;
      stability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The stability of maxillary advancement after Le Fort I osteotomy in retruded maxilla patients&#xD;
      has been an issue that has attracted the attention of numerous researchers. That's why&#xD;
      different fixation methods have been compared in vitro and in vivo.&#xD;
&#xD;
      Prebent plates is one of the recent modifications of the plate systems used in maxillofacial&#xD;
      surgery , they were created to reduce the need for bending and contouring of the titanium&#xD;
      miniplates.&#xD;
&#xD;
      Lye et al.,(the only in vivo study in English), aimed to evaluate the predictability of&#xD;
      advancement surgery with the use of prebent plates in 36 patients &amp; he proved the prebent&#xD;
      plates have been proven to significantly affect the advancement &amp; reliable.&#xD;
&#xD;
      In a biomechanical study, prebent plates provided better results than the standard two plate&#xD;
      scenario in terms of resistance to displacement, permanent deformation and load for breaking.&#xD;
&#xD;
      Fatih Mehmet Coskunses et al., in 2015 has done in vitro study to evaluate the segmental&#xD;
      displacement, and von mises stress on the titanium miniplates &amp; the maximum principal stress&#xD;
      on the bone, with the use of prebent plates and two standard L plates adapted to either the&#xD;
      zygomaticomaxillary buttress or the nasal piriform following anterior advancement of 5 mm or&#xD;
      10 mm by Le Fort I osteotomy.&#xD;
&#xD;
      The results of the study were, In 5 mm maxillary advancement using prebent plates for the&#xD;
      fixation of bone segments resulted in less segmental displacement than the standard two&#xD;
      plate.&#xD;
&#xD;
      Even when adapted posteriorly or anteriorly, the prebent plates were able to be more stable&#xD;
      than two plates technique. Moreover, Not only the one prebent scenario had the lowest&#xD;
      segmental displacements, but also the lowest maximum principal stresses on bone in the&#xD;
      anteriorly adapted group.&#xD;
&#xD;
      These results are due to the structure of the prebent plates that have two arms extending in&#xD;
      opposite directions (anteriorly and posteriorly) and it is suggested that the prebent plates&#xD;
      are preferable alternatives to the traditional two plate configurations in osteotomies with&#xD;
      up to 5 mm advancement. The prebent plates showed similar satisfactory results with 10 mm&#xD;
      advancement only when adapted anteriorly. In contrast, when adapted posteriorly, the prebent&#xD;
      plates resulted in obvious failure in the 10 mm advancement model.&#xD;
&#xD;
      Based on these data , My research will compare the postoperative stability between 2 groups&#xD;
      of retruded maxilla patients having maxillary advancement up to 5 mm&#xD;
&#xD;
        1. the 1st group will be fixed using 2 prebent plates placed at nasal piriform&#xD;
&#xD;
        2. the 2nd group will be fixed using 4 miniplates placed at nasal piriform &amp;&#xD;
           zygmoaticomaxillay buttress.&#xD;
&#xD;
      The aim of this study:&#xD;
&#xD;
      To find out if the two prebent plates provides a stable postoperative maxillary advancement&#xD;
      movement than the traditional four miniplates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Maxillary stability</measure>
    <time_frame>12 months</time_frame>
    <description>Linear measurements (from A point to the nasion perpendicular, A point perpendicular to Frankfort plane) &amp; Angular measurements (SNA , Maxillary depth angle ) will be obtained from the immediate postoperative lateral cephalometry and after 12 months.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Retruded Hypoplastic Maxilla</condition>
  <arm_group>
    <arm_group_label>prebent plate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fixation of le fort I osteotomy using prebent plate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional four miniplates</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>fixation of le fort I osteotomy using conventional four miniplates</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lefort I osteotomy for maxillary advancement</intervention_name>
    <description>fixation of lefort I osteotomy in patients with retruded maxilla with two prebent plates versus four miniplates.</description>
    <arm_group_label>Conventional four miniplates</arm_group_label>
    <arm_group_label>prebent plate</arm_group_label>
    <other_name>four miniplates</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with retruded maxilla &amp; need advancement by le fort I osteotomy.&#xD;
&#xD;
          -  Patients free from any systemic disease &amp; bone metabolism diseases.&#xD;
&#xD;
          -  Patients with no signs or symptoms of temporomandibular joint disorders.&#xD;
&#xD;
          -  No sex predilection&#xD;
&#xD;
          -  Age range ( 18-45)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic disease &amp; bone metabolism diseases.&#xD;
&#xD;
          -  Patients with cleft lip &amp; palate.&#xD;
&#xD;
          -  Patients with temporomandibular joint disorders&#xD;
&#xD;
          -  Patients receiving chemotherapy or radiotherapy &quot;due to the risk of low bone quality&#xD;
             and healing&#xD;
&#xD;
          -  Age less than 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hagar A 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>Coskunses FM, Kan B, Mutlu I, Cilasun U, Celik T. Evaluation of prebent miniplates in fixation of Le Fort I advancement osteotomy with the finite element method. J Craniomaxillofac Surg. 2015 Oct;43(8):1505-10. doi: 10.1016/j.jcms.2015.07.004. Epub 2015 Jul 15.</citation>
    <PMID>26297421</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</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>
  <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/NCT03752944
org study id: CEBD-CU-2018-11-19
nct id: NCT03752944
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In patients with retruded maxilla ,Will the use of two prebent plates produce more stable
      results postoperatively in fixation of Le Fort I osteotomy in maxillary advancement than
      conventional four minplates ? Many studies have been conducted to compare between the two
      plates and these studies showed that the prebent plate, the plate is not excessively twisted
      so that it can be adapted passively leading to less changes in the property of the material
      ,increased titanium contact surface to the bone leading to better force distribution
      resulting in better rigid fixation as no stresses will be transmitted from the plate to the
      bone leading to faster bone healing and consequently better long term postoperative
      stability.
The stability of maxillary advancement after Le Fort I osteotomy in retruded maxilla patients
      has been an issue that has attracted the attention of numerous researchers. That's why
      different fixation methods have been compared in vitro and in vivo.

      Prebent plates is one of the recent modifications of the plate systems used in maxillofacial
      surgery , they were created to reduce the need for bending and contouring of the titanium
      miniplates.

      Lye et al.,(the only in vivo study in English), aimed to evaluate the predictability of
      advancement surgery with the use of prebent plates in 36 patients & he proved the prebent
      plates have been proven to significantly affect the advancement & reliable.

      In a biomechanical study, prebent plates provided better results than the standard two plate
      scenario in terms of resistance to displacement, permanent deformation and load for breaking.

      Fatih Mehmet Coskunses et al., in 2015 has done in vitro study to evaluate the segmental
      displacement, and von mises stress on the titanium miniplates & the maximum principal stress
      on the bone, with the use of prebent plates and two standard L plates adapted to either the
      zygomaticomaxillary buttress or the nasal piriform following anterior advancement of 5 mm or
      10 mm by Le Fort I osteotomy.

      The results of the study were, In 5 mm maxillary advancement using prebent plates for the
      fixation of bone segments resulted in less segmental displacement than the standard two
      plate.

      Even when adapted posteriorly or anteriorly, the prebent plates were able to be more stable
      than two plates technique. Moreover, Not only the one prebent scenario had the lowest
      segmental displacements, but also the lowest maximum principal stresses on bone in the
      anteriorly adapted group.

      These results are due to the structure of the prebent plates that have two arms extending in
      opposite directions (anteriorly and posteriorly) and it is suggested that the prebent plates
      are preferable alternatives to the traditional two plate configurations in osteotomies with
      up to 5 mm advancement. The prebent plates showed similar satisfactory results with 10 mm
      advancement only when adapted anteriorly. In contrast, when adapted posteriorly, the prebent
      plates resulted in obvious failure in the 10 mm advancement model.

      Based on these data , My research will compare the postoperative stability between 2 groups
      of retruded maxilla patients having maxillary advancement up to 5 mm

        1. the 1st group will be fixed using 2 prebent plates placed at nasal piriform

        2. the 2nd group will be fixed using 4 miniplates placed at nasal piriform &
           zygmoaticomaxillay buttress.

      The aim of this study:

      To find out if the two prebent plates provides a stable postoperative maxillary advancement
      movement than the traditional four miniplates.
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: Maxillary stability
time frame: 12 months
description: Linear measurements (from A point to the nasion perpendicular, A point perpendicular to Frankfort plane) & Angular measurements (SNA , Maxillary depth angle ) will be obtained from the immediate postoperative lateral cephalometry and after 12 months.
arm group label: prebent plate
arm group type: Experimental
description: fixation of le fort I osteotomy using prebent plate
arm group label: Conventional four miniplates
arm group type: Active Comparator
description: fixation of le fort I osteotomy using conventional four miniplates
intervention type: Procedure
intervention name: lefort I osteotomy for maxillary advancement
description: fixation of lefort I osteotomy in patients with retruded maxilla with two prebent plates versus four miniplates.
arm group label: Conventional four miniplates
arm group label: prebent plate
other name: four miniplates
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hagar A Mohamed, BDS
role: Principal Investigator
affiliation: Cairo University
last name: Hagar A Mohamed, BDS
phone: 01016799911
email: hagar_elsherif92@yahoo.com
citation: Coskunses FM, Kan B, Mutlu I, Cilasun U, Celik T. Evaluation of prebent miniplates in fixation of Le Fort I advancement osteotomy with the finite element method. J Craniomaxillofac Surg. 2015 Oct;43(8):1505-10. doi: 10.1016/j.jcms.2015.07.004. Epub 2015 Jul 15.
PMID: 26297421
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
sharing ipd: No