<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/NCT03016793</url>
  </required_header>
  <id_info>
    <org_study_id>Pura-28568</org_study_id>
    <nct_id>NCT03016793</nct_id>
  </id_info>
  <brief_title>Alveolar Cleft Grafting Using Two Different Alloplastic Grafts</brief_title>
  <official_title>Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . 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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft&#xD;
      C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device&#xD;
      Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number&#xD;
      0-10&#xD;
&#xD;
      Radiographic outcome:&#xD;
&#xD;
      Outcome name Measurment Device Measurment unite Bone volume&#xD;
&#xD;
      (Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density&#xD;
&#xD;
      (Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would&#xD;
      purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying&#xD;
      than tricalcium phosphate alone in alveolar cleft grafting?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Esthetic satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>outcome measured by numerical scale from 1-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bone volume</measure>
    <time_frame>6 months</time_frame>
    <description>outcome measured by cone beam computed tomography ( CBCT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone density</measure>
    <time_frame>6 months</time_frame>
    <description>Outcome measured by cone beam computed tomography (CBCT)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Alveolar Cleft Grafting</condition>
  <arm_group>
    <arm_group_label>puerarin and β- tricalcium phosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>purabone (puerarin) is an osteoinductive bone grafts used to augment bone healing.&#xD;
β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>β- tricalcium phosphate alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Puerarin</intervention_name>
    <description>purabone (puerarin) is a bone graft used for surgical repair of bony defects.</description>
    <arm_group_label>puerarin and β- tricalcium phosphate</arm_group_label>
    <other_name>purabone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>β- tricalcium phosphate</intervention_name>
    <description>β- tricalcium phosphate is a bone graft used for surgical repair of bony defects</description>
    <arm_group_label>puerarin and β- tricalcium phosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>β- tricalcium phosphate alone</intervention_name>
    <description>β- tricalcium phosphate is a bone graft used for surgical repair of bony defects</description>
    <arm_group_label>β- tricalcium phosphate alone</arm_group_label>
    <other_name>β- tricalcium phosphate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with unilateral alveolar cleft indicated for bone grafting.&#xD;
&#xD;
          2. Patients age range between 8-12years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with any systemic diseases that can affect normal bone and/or wound healing.&#xD;
&#xD;
          2. Patients with bilateral alveolar clefts.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samar Swelam, Phd</last_name>
    <role>Study Director</role>
    <affiliation>faculty of oral and dental medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed H Maklad, BSC</last_name>
    <phone>+201002648553</phone>
    <email>dentomaklad@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mohamad hamed Maklad</name>
      <address>
        <city>Suez</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mohamd H Maklad, BSC</last_name>
      <phone>+201002648553</phone>
      <email>dentomaklad@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamad Hamed Maklad</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puerarin</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/NCT03016793
org study id: Pura-28568
nct id: NCT03016793
lead sponsor: 
has dmc: No
P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft
      C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device
      Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number
      0-10

      Radiographic outcome:

      Outcome name Measurment Device Measurment unite Bone volume

      (Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density

      (Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would
      purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying
      than tricalcium phosphate alone in alveolar cleft grafting?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Esthetic satisfaction
time frame: 6 months
description: outcome measured by numerical scale from 1-10
measure: bone volume
time frame: 6 months
description: outcome measured by cone beam computed tomography ( CBCT)
measure: bone density
time frame: 6 months
description: Outcome measured by cone beam computed tomography (CBCT)
arm group label: puerarin and β- tricalcium phosphate
arm group type: Experimental
description: purabone (puerarin) is an osteoinductive bone grafts used to augment bone healing.
β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
arm group label: β- tricalcium phosphate alone
arm group type: Active Comparator
description: β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
intervention type: Drug
intervention name: Puerarin
description: purabone (puerarin) is a bone graft used for surgical repair of bony defects.
arm group label: puerarin and β- tricalcium phosphate
other name: purabone
intervention type: Drug
intervention name: β- tricalcium phosphate
description: β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
arm group label: puerarin and β- tricalcium phosphate
intervention type: Drug
intervention name: β- tricalcium phosphate alone
description: β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
arm group label: β- tricalcium phosphate alone
other name: β- tricalcium phosphate
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samar Swelam, Phd
role: Study Director
affiliation: faculty of oral and dental medicine
last name: Mohamed H Maklad, BSC
phone: +201002648553
email: dentomaklad@yahoo.com
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamad Hamed Maklad
investigator title: principal investigator
mesh term: Puerarin
sharing ipd: Undecided