<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/NCT03265795</url>
  </required_header>
  <id_info>
    <org_study_id>maxillary reconstruction</org_study_id>
    <nct_id>NCT03265795</nct_id>
  </id_info>
  <brief_title>Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation</brief_title>
  <official_title>Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation</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>
      Surgical ablation of large maxillary cysts usually results in considerable hard and soft&#xD;
      tissue deficits that ultimately affect the final esthetic and functional outcomes.&#xD;
      Reconstruction of such defects; whether primarily or secondarily; offers much better&#xD;
      long-term outcomes. However, primary bony reconstruction becomes potentially complicated in&#xD;
      many cases of such large cysts encroaching or involving the maxillary sinus where a&#xD;
      communication with the maxillary sinus lining may be unavoidable.&#xD;
&#xD;
      Reconstruction of such defects can be accomplished using either vascularized or; more&#xD;
      commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be&#xD;
      another viable option. The simultaneous use of titanium meshes provides physical&#xD;
      three-dimensional support for the bone graft contained within as well as the overlying soft&#xD;
      tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the&#xD;
      difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh&#xD;
      contents from the maxillary sinus cavity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</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>oral health related quality of life</measure>
    <time_frame>4 months</time_frame>
    <description>OHIP-49 questionaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Maxillary Cyst</condition>
  <arm_group>
    <arm_group_label>PEEK patient specific implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this PEEK (poly ether ether ketone) Patient Specific Implant containing autogenous bone graft is used in reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Poly Ether Ether Ketone PSI (patient specific implant).</intervention_name>
    <description>reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).</description>
    <arm_group_label>PEEK patient specific implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of patients from 15 to 60 years old.&#xD;
&#xD;
          2. Patients with unilateral maxillary lesion encroaching maxillary sinus.&#xD;
&#xD;
          3. Dentulous or edentulous patients.&#xD;
&#xD;
          4. 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;
          1. Patients with systemic diseases as history of radiation therapy or chemotherapy,&#xD;
             hematological disorders, neuromotor disorders and autoimmune diseases (may affect&#xD;
             normal healing).&#xD;
&#xD;
          2. Patients with bilateral maxillary lesions.&#xD;
&#xD;
          3. Children under 15 years old.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed Zain, DDS</last_name>
    <phone>00201003363809</phone>
    <email>m_zain_89@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maha Hakam</last_name>
  </overall_contact_backup>
  <reference>
    <citation>Gellrich NC, Schramm A, Hammer B, Rojas S, Cufi D, Lagreze W, Schmelzeisen R. Computer-assisted secondary reconstruction of unilateral posttraumatic orbital deformity. Plast Reconstr Surg. 2002 Nov;110(6):1417-29. doi: 10.1097/01.PRS.0000029807.35391.E5.</citation>
    <PMID>12409759</PMID>
  </reference>
  <reference>
    <citation>Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.</citation>
    <PMID>16327572</PMID>
  </reference>
  <reference>
    <citation>Lethaus B, Kessler P, Boeckman R, Poort LJ, Tolba R. Reconstruction of a maxillary defect with a fibula graft and titanium mesh using CAD/CAM techniques. Head Face Med. 2010 Jul 19;6:16. doi: 10.1186/1746-160X-6-16.</citation>
    <PMID>20642821</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Zain</investigator_full_name>
    <investigator_title>internal resident at oral and maxillofacial department</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ether</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03265795
org study id: maxillary reconstruction
nct id: NCT03265795
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical ablation of large maxillary cysts usually results in considerable hard and soft
      tissue deficits that ultimately affect the final esthetic and functional outcomes.
      Reconstruction of such defects; whether primarily or secondarily; offers much better
      long-term outcomes. However, primary bony reconstruction becomes potentially complicated in
      many cases of such large cysts encroaching or involving the maxillary sinus where a
      communication with the maxillary sinus lining may be unavoidable.

      Reconstruction of such defects can be accomplished using either vascularized or; more
      commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be
      another viable option. The simultaneous use of titanium meshes provides physical
      three-dimensional support for the bone graft contained within as well as the overlying soft
      tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the
      difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh
      contents from the maxillary sinus cavity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: oral health related quality of life
time frame: 4 months
description: OHIP-49 questionaire
arm group label: PEEK patient specific implant
arm group type: Experimental
description: this PEEK (poly ether ether ketone) Patient Specific Implant containing autogenous bone graft is used in reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).
intervention type: Device
intervention name: Poly Ether Ether Ketone PSI (patient specific implant).
description: reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).
arm group label: PEEK patient specific implant
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mohamed Zain, DDS
phone: 00201003363809
email: m_zain_89@hotmail.com
last name: Maha Hakam
citation: Gellrich NC, Schramm A, Hammer B, Rojas S, Cufi D, Lagreze W, Schmelzeisen R. Computer-assisted secondary reconstruction of unilateral posttraumatic orbital deformity. Plast Reconstr Surg. 2002 Nov;110(6):1417-29. doi: 10.1097/01.PRS.0000029807.35391.E5.
PMID: 12409759
citation: Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.
PMID: 16327572
citation: Lethaus B, Kessler P, Boeckman R, Poort LJ, Tolba R. Reconstruction of a maxillary defect with a fibula graft and titanium mesh using CAD/CAM techniques. Head Face Med. 2010 Jul 19;6:16. doi: 10.1186/1746-160X-6-16.
PMID: 20642821
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Zain
investigator title: internal resident at oral and maxillofacial department
mesh term: Ether
sharing ipd: Undecided