<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/NCT03003013</url>
  </required_header>
  <id_info>
    <org_study_id>CU</org_study_id>
    <nct_id>NCT03003013</nct_id>
  </id_info>
  <brief_title>Effect of Biphasic Bone Graft Material With Autologous Platelet-rich Fibrin on Bone Regeneration in a Maxillary Cyst</brief_title>
  <official_title>Effect of Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) on Bone Regeneration in an Odontogenic Maxillary Cyst: 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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich&#xD;
      fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical&#xD;
      trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Odontogenic cysts are the most common form of cystic lesions that affect the oral and&#xD;
      maxillofacial region. Their origin, mechanism of growth, as well as treatment problems have&#xD;
      been often discussed.&#xD;
&#xD;
      Platelet rich fibrin (PRF) is a second generation platelet concentrate first developed in&#xD;
      France by Choukron et al in 2001, prepared from centrifuged autologous blood. It is a fibrin&#xD;
      clot rich in platelets without addition of bovine thrombin, calcium chloride or anticoagulant&#xD;
      during preparation thus eliminating the risks associated with the use of thrombin. Platelet&#xD;
      rich fibrin is derived from a natural and progressive polymerization occurring&#xD;
      centrifugation. A progressive or relatively slow polymerization mode may increase&#xD;
      incorporation of the circulating cytokines in the fibrin meshes which are then released in a&#xD;
      relatively long-term and controllable way which in turn will help in soft tissue healing and&#xD;
      accelerated bone regeneration.&#xD;
&#xD;
      Blood Derivatives Enhancing Bone Regeneration:&#xD;
&#xD;
      1-Fibrin glue: It is classically described as a two component mixture in which concentrated&#xD;
      fibrinogen factor XIII and fibronectin are added to thrombin ,calcium choloride and an&#xD;
      inhibitor of fibrinolysis to form a fibrin clot .&#xD;
&#xD;
      Shortcomings:&#xD;
&#xD;
      The risk of transmission of virus, like human immunodeficiency virus (HIV). 2. Autologous&#xD;
      Fibrin Adhesives: The patient's blood is harvested 1:3 weeks before the intervention and&#xD;
      requires separating one unit of whole blood cell component and plasma fraction for use as&#xD;
      cryoprecipitate.&#xD;
&#xD;
      Shortcomings:&#xD;
&#xD;
        -  Extremely long.&#xD;
&#xD;
        -  Complex protocols. 3. Platelet rich plasma (PRP): It is a modification type of&#xD;
           autologous fibrin adhesives which requires autologous blood collection in the immediate&#xD;
           preoperative period and processing in the centrifugation which is then mixed with bovine&#xD;
           thrombine and calcium chloride at the time of application.&#xD;
&#xD;
      Shortcomings:&#xD;
&#xD;
        1. The use of bovine thrombin puts the patient at risk of life -threating coagulopathies&#xD;
           associated with the development of antibodies to factor V , XI and thrombin .&#xD;
&#xD;
        2. Higher concentration of thrombin impedes cell migration during bone healing.&#xD;
&#xD;
        3. It mediates only the early aspects of bone repair. A variety of treatment modalities&#xD;
           including the use of autogenous bone grafts and bone substitutes materials ,guided&#xD;
           tissue regeneration (GTR) with the use of barrier membranes and growth factors have been&#xD;
           used to stimulate bone regeneration mechanism.The drawbacks associated with autogenous&#xD;
           bone grafts have led to the production of a large number of alternative bone substitute&#xD;
           materials. Their biological behavior depends upon their chemical composition and&#xD;
           physicochemical structure. Bone grafting materials include autografts, allografts,&#xD;
           xenografts and alloplasts. The osteoconductive hydroxyapatite grafting materials have&#xD;
           been widely used to enhance new bone regeneration.&#xD;
&#xD;
      SYMBIOS®:&#xD;
&#xD;
      Biphasic Bone Graft Material (BGM) is a resorbable inorganic bone forming material in&#xD;
      granular form of plant origin derived from red marine algae. The chemical composition of this&#xD;
      interconnected porous biological product is similar to the inorganic part of the human bone.&#xD;
      It is a composition of 20% hydroxyapatite (HA) and 80% β-tricalciumphosphate (ß-TCP). Due to&#xD;
      the high tricalcium- phosphate content of the product it resorbs significantly faster than&#xD;
      pure hydroxyapatite. The biphasic BGM is biocompatible and osteoconductive. The selection of&#xD;
      the two grain sizes is dependent on the defect.&#xD;
&#xD;
      Growth factors represent an area of interest for surgeons attempting to modify and enhance&#xD;
      the wound healing process and tissue regeneration. However, the Platelet-Rich Plasma (PRP) is&#xD;
      already in use for some time by hematologists for transfusions and prevention of bleeding&#xD;
      episodes in patients with severe thrombocytopenia.&#xD;
&#xD;
      Uses of PRF Over PRP:&#xD;
&#xD;
        1. The improved mechanical properties of PRF over conventional PRP translate it into a&#xD;
           biologic matrix that is easy to handle and implant in awide variety of tissue repair&#xD;
           applications.&#xD;
&#xD;
        2. Platelets rich fibrin has increased modulus of elasticity. This property imparts it&#xD;
           better pliability and drapability, allowing it to closely conform to awide variety of&#xD;
           irregular surgical sites and surfaces similar to split thickness skin auto grafts.&#xD;
&#xD;
        3. Platelet rich fibrin can easily be sutured to surgical site.&#xD;
&#xD;
      Benefits of this study to patients:&#xD;
&#xD;
        -  Treatment of cystic lesions.&#xD;
&#xD;
        -  Enhancement of bone regeneration.&#xD;
&#xD;
      Benefits of this study for other clinicians:&#xD;
&#xD;
      The study provides a new modality for the regeneration of new bone after cystic enucleation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Swelling</measure>
    <time_frame>six weeks</time_frame>
    <description>Visual analogue scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bone regeneration</measure>
    <time_frame>from six to nine months</time_frame>
    <description>Gray scale value via cone beam CT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Odontogenic Maxillary Cysts</condition>
  <arm_group>
    <arm_group_label>Biphasic Bone Graft With Autologous Platelet-rich Fibrin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material in combination with PRF in the cystic cavity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biphasic Bone Graft Material only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)</intervention_name>
    <arm_group_label>Biphasic Bone Graft Material only</arm_group_label>
    <arm_group_label>Biphasic Bone Graft With Autologous Platelet-rich Fibrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          1. Age range is 15: 60 years old.&#xD;
&#xD;
          2. A maxillary odontogenic cysts larger than 3 cm in size.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. A maxillary odontogenic cysts smaller than 3 cm in size.&#xD;
&#xD;
          2. A mandibular odontogenic cysts.&#xD;
&#xD;
          3. Non odontogenic cysts.&#xD;
&#xD;
          4. Patients with thrombotic risk factors or taking anti-platelets drugs.&#xD;
&#xD;
          5. Patients with systemic diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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_official>
    <last_name>Niven Abal Latif Askar, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor of Oral&amp; Maxillofacial Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherif AbdelMonem Abdel Aziz, B.D.S.</last_name>
    <phone>(+002)01009026713</phone>
    <email>dr_sherifelsaraf@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Oral &amp; Dental Medicine Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherif AbdelMonem Abdel Aziz, BDS</last_name>
      <phone>(+002)01009026713</phone>
      <email>dr_sherifelsaraf@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sherif Abdel Monem Abdel Aziz</investigator_full_name>
    <investigator_title>Master student</investigator_title>
  </responsible_party>
  <keyword>Odontogenic cysts</keyword>
  <keyword>Bone substitutes materials</keyword>
  <keyword>SYMBIOS®</keyword>
  <keyword>Platelets rich fibrin (PRF)</keyword>
  <keyword>Bone regeneration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</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/NCT03003013
org study id: CU
nct id: NCT03003013
lead sponsor: 
has dmc: No
Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich
      fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical
      trial
Odontogenic cysts are the most common form of cystic lesions that affect the oral and
      maxillofacial region. Their origin, mechanism of growth, as well as treatment problems have
      been often discussed.

      Platelet rich fibrin (PRF) is a second generation platelet concentrate first developed in
      France by Choukron et al in 2001, prepared from centrifuged autologous blood. It is a fibrin
      clot rich in platelets without addition of bovine thrombin, calcium chloride or anticoagulant
      during preparation thus eliminating the risks associated with the use of thrombin. Platelet
      rich fibrin is derived from a natural and progressive polymerization occurring
      centrifugation. A progressive or relatively slow polymerization mode may increase
      incorporation of the circulating cytokines in the fibrin meshes which are then released in a
      relatively long-term and controllable way which in turn will help in soft tissue healing and
      accelerated bone regeneration.

      Blood Derivatives Enhancing Bone Regeneration:

      1-Fibrin glue: It is classically described as a two component mixture in which concentrated
      fibrinogen factor XIII and fibronectin are added to thrombin ,calcium choloride and an
      inhibitor of fibrinolysis to form a fibrin clot .

      Shortcomings:

      The risk of transmission of virus, like human immunodeficiency virus (HIV). 2. Autologous
      Fibrin Adhesives: The patient's blood is harvested 1:3 weeks before the intervention and
      requires separating one unit of whole blood cell component and plasma fraction for use as
      cryoprecipitate.

      Shortcomings:

        -  Extremely long.

        -  Complex protocols. 3. Platelet rich plasma (PRP): It is a modification type of
           autologous fibrin adhesives which requires autologous blood collection in the immediate
           preoperative period and processing in the centrifugation which is then mixed with bovine
           thrombine and calcium chloride at the time of application.

      Shortcomings:

        1. The use of bovine thrombin puts the patient at risk of life -threating coagulopathies
           associated with the development of antibodies to factor V , XI and thrombin .

        2. Higher concentration of thrombin impedes cell migration during bone healing.

        3. It mediates only the early aspects of bone repair. A variety of treatment modalities
           including the use of autogenous bone grafts and bone substitutes materials ,guided
           tissue regeneration (GTR) with the use of barrier membranes and growth factors have been
           used to stimulate bone regeneration mechanism.The drawbacks associated with autogenous
           bone grafts have led to the production of a large number of alternative bone substitute
           materials. Their biological behavior depends upon their chemical composition and
           physicochemical structure. Bone grafting materials include autografts, allografts,
           xenografts and alloplasts. The osteoconductive hydroxyapatite grafting materials have
           been widely used to enhance new bone regeneration.

      SYMBIOS®:

      Biphasic Bone Graft Material (BGM) is a resorbable inorganic bone forming material in
      granular form of plant origin derived from red marine algae. The chemical composition of this
      interconnected porous biological product is similar to the inorganic part of the human bone.
      It is a composition of 20% hydroxyapatite (HA) and 80% β-tricalciumphosphate (ß-TCP). Due to
      the high tricalcium- phosphate content of the product it resorbs significantly faster than
      pure hydroxyapatite. The biphasic BGM is biocompatible and osteoconductive. The selection of
      the two grain sizes is dependent on the defect.

      Growth factors represent an area of interest for surgeons attempting to modify and enhance
      the wound healing process and tissue regeneration. However, the Platelet-Rich Plasma (PRP) is
      already in use for some time by hematologists for transfusions and prevention of bleeding
      episodes in patients with severe thrombocytopenia.

      Uses of PRF Over PRP:

        1. The improved mechanical properties of PRF over conventional PRP translate it into a
           biologic matrix that is easy to handle and implant in awide variety of tissue repair
           applications.

        2. Platelets rich fibrin has increased modulus of elasticity. This property imparts it
           better pliability and drapability, allowing it to closely conform to awide variety of
           irregular surgical sites and surfaces similar to split thickness skin auto grafts.

        3. Platelet rich fibrin can easily be sutured to surgical site.

      Benefits of this study to patients:

        -  Treatment of cystic lesions.

        -  Enhancement of bone regeneration.

      Benefits of this study for other clinicians:

      The study provides a new modality for the regeneration of new bone after cystic enucleation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Swelling
time frame: six weeks
description: Visual analogue scale
measure: bone regeneration
time frame: from six to nine months
description: Gray scale value via cone beam CT
arm group label: Biphasic Bone Graft With Autologous Platelet-rich Fibrin
arm group type: Active Comparator
description: Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material in combination with PRF in the cystic cavity
arm group label: Biphasic Bone Graft Material only
arm group type: Active Comparator
description: Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity
intervention type: Procedure
intervention name: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)
arm group label: Biphasic Bone Graft Material only
arm group label: Biphasic Bone Graft With Autologous Platelet-rich Fibrin
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: No
last name: Niven Abal Latif Askar, PhD
role: Study Director
affiliation: Assistant Professor of Oral& Maxillofacial Surgery
last name: Sherif AbdelMonem Abdel Aziz, B.D.S.
phone: (+002)01009026713
email: dr_sherifelsaraf@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sherif Abdel Monem Abdel Aziz
investigator title: Master student
mesh term: Cysts
sharing ipd: No