<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/NCT03302429</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-09-31</org_study_id>
    <nct_id>NCT03302429</nct_id>
  </id_info>
  <brief_title>Evaluation of Platelet Rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft</brief_title>
  <official_title>Evaluation of Platelet-rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft Defect in the Maxillary Arch: Randomized Controlled 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>
      P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic&#xD;
      calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone&#xD;
      volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial&#xD;
      this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF)&#xD;
      combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone&#xD;
      graft in reconstruction of alveolar cleft defect in maxillary arch.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF)&#xD;
      combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone&#xD;
      graft in reconstruction of alveolar cleft defect in maxillary arch&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Eighteen patients will be divided into two equal groups. Each group comprises nine patients.&#xD;
Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bone height</measure>
    <time_frame>six months postoperative.</time_frame>
    <description>the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bone volume</measure>
    <time_frame>six months postoperative.</time_frame>
    <description>V= (A1xT) + ( A2 xT) + …….+ (An xT) where:&#xD;
V= volume A= area T= thickness of the axial C.T slice N=number of slices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operation duration</measure>
    <time_frame>within 4 hours ( the actual number of hours will be determined intra-operative )</time_frame>
    <description>It is the time elapsed between using the scalable for incision and the last stitch.&#xD;
It will be measured by watch in hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>within 7 days</time_frame>
    <description>Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Alveolar Ridge Abnormality</condition>
  <arm_group>
    <arm_group_label>PRF/ BCP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biphasic calcium phosphate (BCP)&quot;bioceramic bone substitute combined with platelet rich fibrin PRF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>autogenous bone graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PRF/ BCP</intervention_name>
    <description>Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)</description>
    <arm_group_label>PRF/ BCP</arm_group_label>
    <other_name>Easy-graft/BCP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autogenous bone graft</intervention_name>
    <description>Bone obtained from the same individual who receiving the graft</description>
    <arm_group_label>autogenous bone graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from maxillary alveolar cleft&#xD;
&#xD;
          -  Patients' age 8 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Syndromic cases will be excluded&#xD;
&#xD;
          -  Patients suffering from platelets disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hebatallah G Samra El-Shamy</last_name>
    <phone>+201284235900</phone>
    <email>hebatallah_samra@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hassan A Osman, lecturer</last_name>
    <phone>+201001545449</phone>
    <email>hassan_ao@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>3311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hebatallah G Samra El-Shamy</investigator_full_name>
    <investigator_title>resarcher</investigator_title>
  </responsible_party>
  <keyword>Alveolar cleft -Platelet rich fibrin- calcium phosphate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <!-- 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/NCT03302429
org study id: CEBD-CU-2017-09-31
nct id: NCT03302429
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic
      calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone
      volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial
      this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF)
      combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone
      graft in reconstruction of alveolar cleft defect in maxillary arch.
this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF)
      combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone
      graft in reconstruction of alveolar cleft defect in maxillary arch
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
Group A: Platelet-rich Fibrin combined with Biphasic Calcium Phosphate.(interventional group) Group B: autogenous bone graft (controlled group)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: bone height
time frame: six months postoperative.
description: the vertical bone height measured from the most coronal level of the pyriform aperture to the most apical level of the bony bridge.
measure: bone volume
time frame: six months postoperative.
description: V= (A1xT) + ( A2 xT) + …….+ (An xT) where:
V= volume A= area T= thickness of the axial C.T slice N=number of slices
measure: operation duration
time frame: within 4 hours ( the actual number of hours will be determined intra-operative )
description: It is the time elapsed between using the scalable for incision and the last stitch.
It will be measured by watch in hours.
measure: hospital stay
time frame: within 7 days
description: Number of days that patients spend in hospital. Measured by calendar, starting from time of admission ending with time of discharge
arm group label: PRF/ BCP
arm group type: Experimental
description: Biphasic calcium phosphate (BCP)"bioceramic bone substitute combined with platelet rich fibrin PRF
arm group label: autogenous bone graft
arm group type: Active Comparator
description: Autogenous bone graft involving utilizing bone obtained from the same individual receiving the graft
intervention type: Other
intervention name: PRF/ BCP
description: Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)
arm group label: PRF/ BCP
other name: Easy-graft/BCP
intervention type: Other
intervention name: Autogenous bone graft
description: Bone obtained from the same individual who receiving the graft
arm group label: autogenous bone graft
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Hebatallah G Samra El-Shamy
phone: +201284235900
email: hebatallah_samra@yahoo.com
last name: Hassan A Osman, lecturer
phone: +201001545449
email: hassan_ao@yahoo.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hebatallah G Samra El-Shamy
investigator title: resarcher
mesh term: Congenital Abnormalities