<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/NCT03797963</url>
  </required_header>
  <id_info>
    <org_study_id>480CEIH2018</org_study_id>
    <nct_id>NCT03797963</nct_id>
  </id_info>
  <brief_title>Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation</brief_title>
  <official_title>Split-mouth Randomized Clinical Study on the Use of Symbios Xenograft for Sinus Floor Elevation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</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 study aims to evaluate the clinical and radiological behavior, the histological and&#xD;
      morphometrical components, the expression of proteins related to bone formation, and the&#xD;
      analysis of markers of reparative mesenchymal stromal cells, after using two different&#xD;
      xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor&#xD;
      elevation.&#xD;
&#xD;
      A randomized split-mouth clinical study is designed to include patients in need of two-stage&#xD;
      bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of&#xD;
      autogenous cortical bone (collected by a bone scraper from the access window to the maxillary&#xD;
      sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous&#xD;
      cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus.&#xD;
      Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor&#xD;
      elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core&#xD;
      biopsies will be obtained at the site of implant placement 6 months after the floor&#xD;
      elevation. Histological sections will be subjected to histomorphometric and&#xD;
      immunohistochemical evaluation of differentiation markers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">February 27, 2022</completion_date>
  <primary_completion_date type="Actual">February 2, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sinus floor height change</measure>
    <time_frame>From surgery to 6 months</time_frame>
    <description>CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sinus floor height change after 12 months</measure>
    <time_frame>From surgery to 12 months</time_frame>
    <description>CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinus floor height change after 18 months</measure>
    <time_frame>From surgery to 18 months</time_frame>
    <description>CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area of new mineralized tissue</measure>
    <time_frame>6 months</time_frame>
    <description>Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area of non-mineralized tissue</measure>
    <time_frame>6 months</time_frame>
    <description>Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area of remaining graft particles</measure>
    <time_frame>6 months</time_frame>
    <description>Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Sinus Floor Augmentation</condition>
  <arm_group>
    <arm_group_label>PBM+ACB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABB+ACB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PBM+ACB</intervention_name>
    <description>Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone</description>
    <arm_group_label>PBM+ACB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ABB+ACB</intervention_name>
    <description>Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone</description>
    <arm_group_label>ABB+ACB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Partially edentulous patients.&#xD;
&#xD;
          -  Kennedy class I in the upper jaw.&#xD;
&#xD;
          -  Less than 5 mm of residual crestal bone to the maxillary sinus.&#xD;
&#xD;
          -  Need for the replacement of teeth with dental implants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sinus pathology (sinusitis, mucocele, cysts).&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  Previous long-term (&gt;3 months) use of drugs known to affect bone metabolism, such as&#xD;
             bisphosphonates.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo Galindo-Moreno, DDS, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de Granada</name>
      <address>
        <city>Granada</city>
        <zip>18071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26.</citation>
    <PMID>29071736</PMID>
  </reference>
  <reference>
    <citation>Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.</citation>
    <PMID>17355356</PMID>
  </reference>
  <results_reference>
    <citation>Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.</citation>
    <PMID>35224778</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>May 20, 2023</last_update_submitted>
  <last_update_submitted_qc>May 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Pablo Galindo-Moreno</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>Maxillary sinus augmentation</keyword>
  <keyword>Sinus lift</keyword>
  <keyword>Biomaterial</keyword>
  <keyword>Anorganic bovine bone</keyword>
  <keyword>Porcine bone mineral</keyword>
  <keyword>Implant dentistry</keyword>
  <!-- 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/NCT03797963
org study id: 480CEIH2018
nct id: NCT03797963
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to evaluate the clinical and radiological behavior, the histological and
      morphometrical components, the expression of proteins related to bone formation, and the
      analysis of markers of reparative mesenchymal stromal cells, after using two different
      xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor
      elevation.

      A randomized split-mouth clinical study is designed to include patients in need of two-stage
      bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of
      autogenous cortical bone (collected by a bone scraper from the access window to the maxillary
      sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous
      cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus.
      Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor
      elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core
      biopsies will be obtained at the site of implant placement 6 months after the floor
      elevation. Histological sections will be subjected to histomorphometric and
      immunohistochemical evaluation of differentiation markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Sinus floor height change
time frame: From surgery to 6 months
description: CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change
measure: Sinus floor height change after 12 months
time frame: From surgery to 12 months
description: CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change
measure: Sinus floor height change after 18 months
time frame: From surgery to 18 months
description: CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change
measure: Area of new mineralized tissue
time frame: 6 months
description: Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
measure: Area of non-mineralized tissue
time frame: 6 months
description: Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure
measure: Area of remaining graft particles
time frame: 6 months
description: Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure
arm group label: PBM+ACB
arm group type: Active Comparator
description: Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone
arm group label: ABB+ACB
arm group type: Experimental
description: Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone
intervention type: Device
intervention name: PBM+ACB
description: Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone
arm group label: PBM+ACB
intervention type: Device
intervention name: ABB+ACB
description: Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone
arm group label: ABB+ACB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pablo Galindo-Moreno, DDS, MS, PhD
role: Principal Investigator
affiliation: Universidad de Granada
facility: 
country: Spain
citation: Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26.
PMID: 29071736
citation: Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.
PMID: 17355356
citation: Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3.
PMID: 35224778
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Pablo Galindo-Moreno
investigator title: Full Professor