xml: <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/NCT05985317</url>
    </required_header>
    <id_info>
      <org_study_id>The membrane effect on the BM</org_study_id>
      <nct_id>NCT05985317</nct_id>
    </id_info>
    <brief_title>Effect of Collagen Versus PRF on BMA Osteogenic Potential</brief_title>
    <official_title>Evaluation of Collagen Versus Platelet Rich Fibrin Membrane on the Osteogenic Potential of Bone Marrow Aspirate Concentrate (BMAC) for Lateral Sinus Floor Augmentation : A 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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and&#xD;
        before suturing&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Assessment of the effect of membrane overlying bone marrow aspirate concentrate - bovine&#xD;
        graft mixture in sinus lift procedure&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 25, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Radiographic Bone density assessment</measure>
      <time_frame>4 months ( immediate - 4 months postoperative)</time_frame>
      <description>Bone density measurements on Cone beam CT/CBCT immediate and 4 months radiographic density measurements in haunsfield units, immediate and 4 months postoperative</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radiographic Bone height assessment</measure>
      <time_frame>4 months ( immediate - 4 months postoperative)</time_frame>
      <description>Assessment of bone hight on CBCT, mmediate and at 4 months postoperative</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2</enrollment>
    <condition>Bone Loss, Alveolar</condition>
    <arm_group>
      <arm_group_label>Collagen membrane covering BMAC loaded on bovine graft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Collagen membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PRF membrane covering BMAC loaded on bovine graft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Platelet rich fibrin membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Collagen membrane over BMAC/bovine graft in sinus lift</intervention_name>
      <description>Collagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure</description>
      <arm_group_label>Collagen membrane covering BMAC loaded on bovine graft</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PRF membrane over BMAC/bovine graft in sinus lift</intervention_name>
      <description>PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure</description>
      <arm_group_label>PRF membrane covering BMAC loaded on bovine graft</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that&#xD;
               need bone augmentation before delayed implant placement.&#xD;
  &#xD;
            -  Highly motivated patients&#xD;
  &#xD;
            -  Age more than 18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients suffering from any systemic disease or those under any medication that may&#xD;
               interfere with normal bone healing.&#xD;
  &#xD;
            -  Patients suffering from any sinus pathosis.&#xD;
  &#xD;
            -  Patients with conditions that could potentially compromise Bone Marrow ( BM)quality,&#xD;
               including history of hematologic malignancy, current chemotherapy, BM suppressive and&#xD;
               anti-platelet medications, previous BM Aspiration, or acute illness.&#xD;
  &#xD;
            -  Heavy smoker (&gt; 20 cigarettes daily)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eman Said</last_name>
      <role>Study Director</role>
      <affiliation>Lecturer at Faculty of Dentistry, Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Walaa Kadry</last_name>
      <phone>+201061527359</phone>
      <email>walaakadry@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Abmed Amin</last_name>
      <phone>+201061527358</phone>
      <email>ahmamin2001.aa@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Dentistry, Cairo University</name>
        <address>
          <city>Cairo</city>
          <zip>02</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Walaa Kadry, Phd</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Walaa Kadry</investigator_full_name>
      <investigator_title>Lecturer of oral and Maxillofacial Surgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alveolar Bone Loss</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985317
  org study id: The membrane effect on the BM
  nct id: NCT05985317
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and
        before suturing
  Assessment of the effect of membrane overlying bone marrow aspirate concentrate - bovine
        graft mixture in sinus lift procedure
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Radiographic Bone density assessment
  time frame: 4 months ( immediate - 4 months postoperative)
  description: Bone density measurements on Cone beam CT/CBCT immediate and 4 months radiographic density measurements in haunsfield units, immediate and 4 months postoperative
  measure: Radiographic Bone height assessment
  time frame: 4 months ( immediate - 4 months postoperative)
  description: Assessment of bone hight on CBCT, mmediate and at 4 months postoperative
  arm group label: Collagen membrane covering BMAC loaded on bovine graft
  arm group type: Active Comparator
  description: Collagen membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative
  arm group label: PRF membrane covering BMAC loaded on bovine graft
  arm group type: Active Comparator
  description: Platelet rich fibrin membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative
  intervention type: Procedure
  intervention name: Collagen membrane over BMAC/bovine graft in sinus lift
  description: Collagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
  arm group label: Collagen membrane covering BMAC loaded on bovine graft
  intervention type: Procedure
  intervention name: PRF membrane over BMAC/bovine graft in sinus lift
  description: PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
  arm group label: PRF membrane covering BMAC loaded on bovine graft
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eman Said
  role: Study Director
  affiliation: Lecturer at Faculty of Dentistry, Cairo University
  last name: Walaa Kadry
  phone: +201061527359
  email: walaakadry@dentistry.cu.edu.eg
  last name: Abmed Amin
  phone: +201061527358
  email: ahmamin2001.aa@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Walaa Kadry
  investigator title: Lecturer of oral and Maxillofacial Surgery
  mesh term: Alveolar Bone Loss