<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/NCT03010345</url>
  </required_header>
  <id_info>
    <org_study_id>Cairo university kasr el ainy</org_study_id>
    <nct_id>NCT03010345</nct_id>
  </id_info>
  <brief_title>The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft</brief_title>
  <official_title>The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft</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>
      patient receiving treatment using the osmed expander will have enough soft tissue coverage&#xD;
      securing the bone graft which will be placed in a later stage to close the alveolar cleft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence&#xD;
      and will have a higher volume of soft tissue at the stage of bone grafting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 1</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)</measure>
    <time_frame>21 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Cleft of Alveolar Ridge</condition>
  <arm_group>
    <arm_group_label>Osmed self inflating tissue expanders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iliac bone graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placement of bone graft without the use of self inflating expanders</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Osmed self inflating tissue expanders</intervention_name>
    <description>Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage</description>
    <arm_group_label>Osmed self inflating tissue expanders</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Iliac bone graft</intervention_name>
    <description>Bone grafting the cleft without the use of osmed self inflating tissue expander</description>
    <arm_group_label>Iliac bone graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically free patients.&#xD;
&#xD;
          -  Patients suffering from alveolar cleft with anterior fistulas.&#xD;
&#xD;
          -  Age Between 7 and 13 Years&#xD;
&#xD;
          -  Both sexes.&#xD;
&#xD;
          -  Patients physically able to tolerate surgical and restorative procedures. Good oral&#xD;
             hygiene.&#xD;
&#xD;
          -  Highly motivated patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non motivated patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Galal El Behiry, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sherif Hany shams</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <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/NCT03010345
org study id: Cairo university kasr el ainy
nct id: NCT03010345
lead sponsor: 
has dmc: No
patient receiving treatment using the osmed expander will have enough soft tissue coverage
      securing the bone graft which will be placed in a later stage to close the alveolar cleft.
to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence
      and will have a higher volume of soft tissue at the stage of bone grafting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
time frame: 21 days
measure: Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)
time frame: 6 months
arm group label: Osmed self inflating tissue expanders
arm group type: Experimental
description: All patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula
arm group label: Iliac bone graft
arm group type: Experimental
description: Placement of bone graft without the use of self inflating expanders
intervention type: Device
intervention name: Osmed self inflating tissue expanders
description: Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage
arm group label: Osmed self inflating tissue expanders
intervention type: Other
intervention name: Iliac bone graft
description: Bone grafting the cleft without the use of osmed self inflating tissue expander
arm group label: Iliac bone graft
criteria: 
gender: All
minimum age: 7 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Galal El Behiry, Phd
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sherif Hany shams
investigator title: Principal investigator
sharing ipd: No