<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/NCT03757195</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-11-16</org_study_id>
    <nct_id>NCT03757195</nct_id>
  </id_info>
  <brief_title>Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix</brief_title>
  <official_title>Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can&#xD;
      be used in grafting in anterior zone giving a good results and bone substitution occur using&#xD;
      allograft or xenograft.&#xD;
&#xD;
      The bone graft have a good consistency when it mixed with plasma give easy application,&#xD;
      strength and stability of the graft. Also plasma rich with CGF (Cellular growth factors).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients suffering from anterior maxillary vertical and horizontal bone loss will be treated&#xD;
      using a xeno-graft mixed with the same patient plasma that extracted from his own blood&#xD;
      during the operation this graft will be stabilized by collagen membrane and surgical tags.&#xD;
&#xD;
      Patients will be follow up for 6 months to measure amount of bone loss of the xeno-graft&#xD;
      during this period post operative using C.B.C.T&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">October 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 29, 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>amount of bone loss</measure>
    <time_frame>change from baseline at 6 months</time_frame>
    <description>amount of bone loss after xenograft by CBCT</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Alveolar Ridge Abnormality of Maxilla</condition>
  <arm_group>
    <arm_group_label>augmentation by xenograft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>xenograft mixed with plasma extracted from blood</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Augmentation</intervention_name>
    <description>combination product</description>
    <arm_group_label>augmentation by xenograft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: from 20 to 40 years old&#xD;
&#xD;
          -  no history of previous grafting.&#xD;
&#xD;
          -  no History of previous implant placement&#xD;
&#xD;
          -  Medically Free e.g no debilitating diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker patients.&#xD;
&#xD;
          -  Alcoholic patients&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Drug Abusers.&#xD;
&#xD;
          -  Hypertensive , Diabetic, having Problems or disease in Kidney and/or liver.&#xD;
&#xD;
          -  Thyroid Disease.&#xD;
&#xD;
          -  Problem in Vit.D absorption or in calcitonin hormone secretion.&#xD;
&#xD;
          -  History of blood transfusion or donating blood less than 4 months.&#xD;
&#xD;
          -  Patient under Corticosteroid therapy.&#xD;
&#xD;
          -  Neurologicaly unstable patients.&#xD;
&#xD;
          -  History of radiotherapy or chemo-therapy.&#xD;
&#xD;
          -  Patient undergo Spect C.T Scan less than 4 Months .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tarek I. Abdallah, P.H.D</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hany M Ahmed, B.D.S</last_name>
    <phone>00201091971228</phone>
    <email>hanyyusf4@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tarek I Abdallah, P.H.D</last_name>
    <phone>01282931864</phone>
    <email>t_ghareeb@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cairo Univerisity</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hany M Ahmed, BDS</last_name>
      <phone>00201091971228</phone>
      <email>hanyyusf4@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tarek I. Abdallah, P.H.D</last_name>
    </contact>
    <investigator>
      <last_name>Hany M. Ahmed, B.D.S</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2017</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>hany mostafa ahmed</investigator_full_name>
    <investigator_title>Resident of Oral Surgery in Nahda University</investigator_title>
  </responsible_party>
  <keyword>Mineralized plasmatic matrix</keyword>
  <keyword>sticky bone</keyword>
  <keyword>plasma</keyword>
  <keyword>autogeous fibrin glue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT03757195
org study id: CEBC-CU-2017-11-16
nct id: NCT03757195
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can
      be used in grafting in anterior zone giving a good results and bone substitution occur using
      allograft or xenograft.

      The bone graft have a good consistency when it mixed with plasma give easy application,
      strength and stability of the graft. Also plasma rich with CGF (Cellular growth factors).
Patients suffering from anterior maxillary vertical and horizontal bone loss will be treated
      using a xeno-graft mixed with the same patient plasma that extracted from his own blood
      during the operation this graft will be stabilized by collagen membrane and surgical tags.

      Patients will be follow up for 6 months to measure amount of bone loss of the xeno-graft
      during this period post operative using C.B.C.T
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: amount of bone loss
time frame: change from baseline at 6 months
description: amount of bone loss after xenograft by CBCT
arm group label: augmentation by xenograft
arm group type: Experimental
description: xenograft mixed with plasma extracted from blood
intervention type: Procedure
intervention name: Augmentation
description: combination product
arm group label: augmentation by xenograft
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tarek I. Abdallah, P.H.D
role: Study Director
affiliation: Cairo University
last name: Hany M Ahmed, B.D.S
phone: 00201091971228
email: hanyyusf4@gmail.com
last name: Tarek I Abdallah, P.H.D
phone: 01282931864
email: t_ghareeb@hotmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: hany mostafa ahmed
investigator title: Resident of Oral Surgery in Nahda University
mesh term: Congenital Abnormalities
sharing ipd: No