<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/NCT04414423</url>
  </required_header>
  <id_info>
    <org_study_id>BMC AlvCleft</org_study_id>
    <nct_id>NCT04414423</nct_id>
  </id_info>
  <brief_title>Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting</brief_title>
  <official_title>Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical &amp; Radiographic Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fayoum 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 study will be to analyze the newly formed bone volume and density, 6 months&#xD;
      after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow&#xD;
      concentrate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twelve patients with unilateral alveolar cleft will be enrolled in this randomized&#xD;
      comparative study.&#xD;
&#xD;
      The patients will be divided into two groups, the control (group A) who received illiac&#xD;
      cancellous bone graft and study group who received a combination of bone marrow concentrate&#xD;
      and illiac cancellous bone graft (group B).&#xD;
&#xD;
      Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar&#xD;
      defect volume. Six months postoperative CBCT images will be done and postoperative newly bone&#xD;
      formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated&#xD;
      as follows: BF% = (formed volume/alveolar defect) × 100%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 20, 2021</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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bone volume</measure>
    <time_frame>six months postoperative</time_frame>
    <description>V= (A1xT) + ( A2 xT) + …….+ (An xT) where: V= volume A= area T= thickness of the axial C.T slice N=number of slices</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bone density</measure>
    <time_frame>six months postoperative</time_frame>
    <description>the average bone density will be measured from the CBCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone formation ratio</measure>
    <time_frame>six months postoperative</time_frame>
    <description>BF% = (formed volume/alveolar defect) × 100%.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Alveolar Cleft Grafting</condition>
  <arm_group>
    <arm_group_label>Bone marrow concentrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bone marrow concentrate combined with Autogenous bone graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>autogenous bone graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>grafting with autogenous bone graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bone marrow concentrate alveolar cleft grafting</intervention_name>
    <description>patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate</description>
    <arm_group_label>Bone marrow concentrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autogenous alveolar grafting</intervention_name>
    <description>patients will undergo surgery to repair alveolar cleft with autogenous bone 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;
          -  Patient with Primary, complete cleft lip&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Syndromic cases will be excluded&#xD;
&#xD;
          -  Previous operated cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <zip>21523</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Fayoum</city>
        <zip>63514</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Pinheiro FHSL, Drummond RJ, Frota CM, Bartzela TN, Dos Santos PB. Comparison of early and conventional autogenous secondary alveolar bone graft in children with cleft lip and palate: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):385-397. doi: 10.1111/ocr.12394. Epub 2020 Jun 28.</citation>
    <PMID>32446283</PMID>
  </reference>
  <reference>
    <citation>Ziegler CG, Van Sloun R, Gonzalez S, Whitney KE, DePhillipo NN, Kennedy MI, Dornan GJ, Evans TA, Huard J, LaPrade RF. Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Am J Sports Med. 2019 Jul;47(9):2174-2187. doi: 10.1177/0363546519832003. Epub 2019 Apr 29.</citation>
    <PMID>31034242</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 5, 2021</last_update_submitted>
  <last_update_submitted_qc>December 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fayoum University</investigator_affiliation>
    <investigator_full_name>Alshaimaa Ahmed shabaan</investigator_full_name>
    <investigator_title>associate professor in oral &amp; maxillofacial Surgery Department</investigator_title>
  </responsible_party>
  <keyword>bone marrow concentrate</keyword>
  <keyword>alveolar cleft</keyword>
  <keyword>CBCT</keyword>
  <keyword>Bone density</keyword>
  <keyword>bone volume</keyword>
  <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/NCT04414423
org study id: BMC AlvCleft
nct id: NCT04414423
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study will be to analyze the newly formed bone volume and density, 6 months
      after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow
      concentrate.
Twelve patients with unilateral alveolar cleft will be enrolled in this randomized
      comparative study.

      The patients will be divided into two groups, the control (group A) who received illiac
      cancellous bone graft and study group who received a combination of bone marrow concentrate
      and illiac cancellous bone graft (group B).

      Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar
      defect volume. Six months postoperative CBCT images will be done and postoperative newly bone
      formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated
      as follows: BF% = (formed volume/alveolar defect) × 100%.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
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: bone density
time frame: six months postoperative
description: the average bone density will be measured from the CBCT
measure: bone formation ratio
time frame: six months postoperative
description: BF% = (formed volume/alveolar defect) × 100%.
arm group label: Bone marrow concentrate
arm group type: Experimental
description: Bone marrow concentrate combined with Autogenous bone graft
arm group label: autogenous bone graft
arm group type: Active Comparator
description: grafting with autogenous bone graft
intervention type: Procedure
intervention name: bone marrow concentrate alveolar cleft grafting
description: patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
arm group label: Bone marrow concentrate
intervention type: Procedure
intervention name: Autogenous alveolar grafting
description: patients will undergo surgery to repair alveolar cleft with autogenous bone graft
arm group label: autogenous bone graft
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
facility: 
country: Egypt
citation: Pinheiro FHSL, Drummond RJ, Frota CM, Bartzela TN, Dos Santos PB. Comparison of early and conventional autogenous secondary alveolar bone graft in children with cleft lip and palate: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):385-397. doi: 10.1111/ocr.12394. Epub 2020 Jun 28.
PMID: 32446283
citation: Ziegler CG, Van Sloun R, Gonzalez S, Whitney KE, DePhillipo NN, Kennedy MI, Dornan GJ, Evans TA, Huard J, LaPrade RF. Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Am J Sports Med. 2019 Jul;47(9):2174-2187. doi: 10.1177/0363546519832003. Epub 2019 Apr 29.
PMID: 31034242
responsible party type: Principal Investigator
investigator affiliation: Fayoum University
investigator full name: Alshaimaa Ahmed shabaan
investigator title: associate professor in oral & maxillofacial Surgery Department
sharing ipd: No