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/NCT05988086</url>
    </required_header>
    <id_info>
      <org_study_id>R-OS-9-22-1</org_study_id>
      <nct_id>NCT05988086</nct_id>
    </id_info>
    <brief_title>Double Closure of Nasal Layer in Alveolar Cleft Grafting</brief_title>
    <official_title>Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this prospective study is to evaluate both clinically and radiologically the&#xD;
        efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer&#xD;
        closure in secondary alveolar cleft repair.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients and methods: Twenty-four patients with alveolar clefts will be included in this&#xD;
        study. The patients will be evaluated with age ranging between (7 - 12) years. The patients&#xD;
        will be received, clinically and radiologically examined, and managed at the Oral and&#xD;
        Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.&#xD;
  &#xD;
        The selected children should possess the following criteria: Their permanent canines either&#xD;
        not or partially erupted, has no systemic disorder which can affect the grafting outcome and&#xD;
        healing process such as juvenile diabetes mellitus, kidney, liver, or blood diseases and has&#xD;
        no associated craniofacial syndromes. The patients will be classified into two groups&#xD;
        according to incorporation of autologous platelet rich fibrin or collagen membrane for nasal&#xD;
        layer closure with the grafting material, as follow: Group 1: This will include 12 children&#xD;
        in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin&#xD;
        with autogenous chin bone. Group 2: This will include 12 children in whom nasal layer of&#xD;
        alveolar cleft will be repaired using collagen membrane with autogenous chin bone.&#xD;
  &#xD;
        Preoperative evaluation of alveolar cleft site:&#xD;
  &#xD;
        all patients will be examined clinically and radiologically. Clinical examination: This will&#xD;
        consider the stability of maxillary segments, presence of old scar, asymmetry of the alar&#xD;
        base, presence of oronasal fistula, and the presence of erupting teeth in the cleft.&#xD;
  &#xD;
        Radiological examination: Panoramic radiographs will be done for each patient and examined as&#xD;
        regard: the morphology of the cleft area, the size of the cleft side, the presence or absence&#xD;
        of permanent lateral incisor and canine, the development of root length, and stage of&#xD;
        eruption of permanent canine and lateral incisor. In addition, Axial computed tomography (CT)&#xD;
        scans will be done for each patient to assess and measure local bone mineral density of&#xD;
        grafted alveolar bone cleft.&#xD;
  &#xD;
        Postoperative evaluation of the grafted site:&#xD;
  &#xD;
        The grafted site will be evaluated clinically for healing condition at the follow up periods&#xD;
        (1st week, then 1st , 3rd ,6th ,and 9th month postoperatively) ; regarding the presence of&#xD;
        inflammation or infection , the soft tissue scar overlying the bone graft , tenderness of&#xD;
        bone graft site , recurrence of oronasal fistula , alveolar ridge contour in cleft region and&#xD;
        eruption of cleft related teeth . Radiological evaluation will be done for each patient using&#xD;
        Axial computed tomography (CT) scans at the follow up period (3rd and 9th month&#xD;
        postoperatively) to assess and measure local bone mineral density.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">October 10, 2022</start_date>
    <completion_date type="Anticipated">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">March 10, 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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>visual analogue scale</measure>
      <time_frame>1 month</time_frame>
      <description>0 representing no pain and 10 representing the highest level of pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>inflammation score scale</measure>
      <time_frame>1 month</time_frame>
      <description>0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>density of bone</measure>
      <time_frame>1 month</time_frame>
      <description>density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>bone mineral density.</measure>
      <time_frame>9 months</time_frame>
      <description>density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Alveolar Cleft</condition>
    <arm_group>
      <arm_group_label>Group 1: platelet rich fibrin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2:collagen membrane</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>platelet rich fibrin</intervention_name>
      <description>12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.</description>
      <arm_group_label>Group 1: platelet rich fibrin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>collagen membrane</intervention_name>
      <description>12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.</description>
      <arm_group_label>Group 2:collagen membrane</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patients with unilateral alveolar cleft&#xD;
  &#xD;
            2. the patient's permenant canines either not or partially erupted&#xD;
  &#xD;
            3. medically free patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with bilateral alveolar cleft&#xD;
  &#xD;
            2. medically compromised patients&#xD;
  &#xD;
            3. Any associated craniofacial syndromes.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marwa T Ibrahim, lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tanta University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Egypt</name>
        <address>
          <city>Tanta</city>
          <zip>3111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 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>Tanta University</investigator_affiliation>
      <investigator_full_name>Marwa Taha Ibrahim</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <keyword>alveolar cleft</keyword>
    <keyword>collagen membrane</keyword>
    <keyword>platelet rich fibrin</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05988086
  org study id: R-OS-9-22-1
  nct id: NCT05988086
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this prospective study is to evaluate both clinically and radiologically the
        efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer
        closure in secondary alveolar cleft repair.
  Patients and methods: Twenty-four patients with alveolar clefts will be included in this
        study. The patients will be evaluated with age ranging between (7 - 12) years. The patients
        will be received, clinically and radiologically examined, and managed at the Oral and
        Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
  
        The selected children should possess the following criteria: Their permanent canines either
        not or partially erupted, has no systemic disorder which can affect the grafting outcome and
        healing process such as juvenile diabetes mellitus, kidney, liver, or blood diseases and has
        no associated craniofacial syndromes. The patients will be classified into two groups
        according to incorporation of autologous platelet rich fibrin or collagen membrane for nasal
        layer closure with the grafting material, as follow: Group 1: This will include 12 children
        in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin
        with autogenous chin bone. Group 2: This will include 12 children in whom nasal layer of
        alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
  
        Preoperative evaluation of alveolar cleft site:
  
        all patients will be examined clinically and radiologically. Clinical examination: This will
        consider the stability of maxillary segments, presence of old scar, asymmetry of the alar
        base, presence of oronasal fistula, and the presence of erupting teeth in the cleft.
  
        Radiological examination: Panoramic radiographs will be done for each patient and examined as
        regard: the morphology of the cleft area, the size of the cleft side, the presence or absence
        of permanent lateral incisor and canine, the development of root length, and stage of
        eruption of permanent canine and lateral incisor. In addition, Axial computed tomography (CT)
        scans will be done for each patient to assess and measure local bone mineral density of
        grafted alveolar bone cleft.
  
        Postoperative evaluation of the grafted site:
  
        The grafted site will be evaluated clinically for healing condition at the follow up periods
        (1st week, then 1st , 3rd ,6th ,and 9th month postoperatively) ; regarding the presence of
        inflammation or infection , the soft tissue scar overlying the bone graft , tenderness of
        bone graft site , recurrence of oronasal fistula , alveolar ridge contour in cleft region and
        eruption of cleft related teeth . Radiological evaluation will be done for each patient using
        Axial computed tomography (CT) scans at the follow up period (3rd and 9th month
        postoperatively) to assess and measure local bone mineral density.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: visual analogue scale
  time frame: 1 month
  description: 0 representing no pain and 10 representing the highest level of pain
  measure: inflammation score scale
  time frame: 1 month
  description: 0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
  measure: density of bone
  time frame: 1 month
  description: density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU
  measure: bone mineral density.
  time frame: 9 months
  description: density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU
  arm group label: Group 1: platelet rich fibrin
  arm group type: Active Comparator
  description: Group 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.
  arm group label: Group 2:collagen membrane
  arm group type: Active Comparator
  description: Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
  intervention type: Procedure
  intervention name: platelet rich fibrin
  description: 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone.
  arm group label: Group 1: platelet rich fibrin
  intervention type: Procedure
  intervention name: collagen membrane
  description: 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.
  arm group label: Group 2:collagen membrane
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marwa T Ibrahim, lecturer
  role: Principal Investigator
  affiliation: Tanta University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Marwa Taha Ibrahim
  investigator title: lecturer
  sharing ipd: No