<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/NCT04433117</url>
  </required_header>
  <id_info>
    <org_study_id>58349</org_study_id>
    <nct_id>NCT04433117</nct_id>
  </id_info>
  <brief_title>Bone Material Comparison in Maxillary Sinus Augmentation</brief_title>
  <official_title>Bone Quality and Quantity in the Maxillary Sinus Grafted With Xenograft or Synthetic Bone Substitute: A Radiographic and Histomorphometric Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohanad Al-Sabbagh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction&#xD;
      when socket preservation is not applied. In addition, extraction of posterior maxillary teeth&#xD;
      causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the&#xD;
      teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main&#xD;
      challenges for dental implant placement. Different bone substitutes have been used to augment&#xD;
      bone in pneumatized maxillary sinuses.&#xD;
&#xD;
      Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a&#xD;
      viable alternative.&#xD;
&#xD;
      Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of&#xD;
      new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with&#xD;
      xenografts revealed newly formed bone to be mostly woven bone with some remodeling to&#xD;
      lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts&#xD;
      when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to&#xD;
      be an effective method for maxillary sinus grafting and demonstrate limited resorption over&#xD;
      time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully&#xD;
      integrate based on recent histomorphometric studies. Vascularization and trabecular bone&#xD;
      formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS&#xD;
      includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite&#xD;
      (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3&#xD;
      salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis).&#xD;
      ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3)&#xD;
      allowing for the uptake of calcium ions from the physiological solution and releasing&#xD;
      phosphate and silicate ions which aid in bone formation. A material with such properties will&#xD;
      substitute bone in a more controlled and effective combination that can be obtained in many&#xD;
      clinical situations, without the disadvantages found with autograft. ShefaBone has&#xD;
      demonstrated successful regenerative properties for bony defects. To our knowledge, there is&#xD;
      no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary&#xD;
      sinus. This aim of this current study is to compare SCPC to commonly used xenograft material&#xD;
      in an augmented maxillary sinus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of&#xD;
           dental implants and subsequent restorations, approximately 20 patients will be randomly&#xD;
           assigned to receive an augmentation of the maxillary sinus region using either Shefabone&#xD;
           (synthetic bone) or Bio-Oss (xenograft).&#xD;
&#xD;
        2. With the use of pre-operative and post-operative limited view CBCT radiography, the&#xD;
           maxillary sinus bone density will be assessed and compared between the individuals&#xD;
           receiving Shefabone and the individuals receiving xenograft material.&#xD;
&#xD;
        3. Histomorphometric analysis will be used to assess, compare and contrast the quality and&#xD;
           the quantity of the new vital bone cells generated when using these different graft&#xD;
           materials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">March 1, 2023</completion_date>
  <primary_completion_date type="Actual">February 14, 2023</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>
    <intervention_model_description>Randomized controlled clinical trial. Entails 2 groups of subjects which will be randomly assigned. Group 1 will be the control group, and group 2 is test group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Density - Limited View CBCT Measurements</measure>
    <time_frame>5 months</time_frame>
    <description>Bone density will be measured by limited view CBCT radiography pre- and post-operatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone Quality</measure>
    <time_frame>5.5 months</time_frame>
    <description>Bone quality will be measured using histomorphometric analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Alveolar Bone Resorption</condition>
  <condition>Sequela</condition>
  <condition>Tooth Extrusion</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Shefabone</intervention_name>
    <description>Silica-calcium phosphate composite.</description>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bio-Oss</intervention_name>
    <description>Xenograft Bone substitute. Bone from animals.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Bio-Oss by Geistlich</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 to 75 years of age&#xD;
&#xD;
          -  at least one maxillary edentulous posterior site requiring maxillary sinus grafting&#xD;
             and replacement with a dental implant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current smokers/tobacco users&#xD;
&#xD;
          -  are pregnant&#xD;
&#xD;
          -  have active periodontal disease&#xD;
&#xD;
          -  have uncontrolled diabetes&#xD;
&#xD;
          -  have any autoimmune disease&#xD;
&#xD;
          -  have kidney disease&#xD;
&#xD;
          -  have liver disease&#xD;
&#xD;
          -  are receiving radiation or chemotherapy&#xD;
&#xD;
          -  have any type of radiographic periapical pathology such as a periapical abscess.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohanad Al-Sabbagh, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Mohanad Al-Sabbagh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Sinus pneumatization</keyword>
  <keyword>Socket preservation</keyword>
  <keyword>Sinus augmentation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Resorption</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Beneficial information for further research around the topic and/or information that may aid/benefit subjects or dentists in treatment may be shared.</ipd_description>
  </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/NCT04433117
org study id: 58349
nct id: NCT04433117
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction
      when socket preservation is not applied. In addition, extraction of posterior maxillary teeth
      causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the
      teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main
      challenges for dental implant placement. Different bone substitutes have been used to augment
      bone in pneumatized maxillary sinuses.

      Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a
      viable alternative.

      Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of
      new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with
      xenografts revealed newly formed bone to be mostly woven bone with some remodeling to
      lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts
      when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to
      be an effective method for maxillary sinus grafting and demonstrate limited resorption over
      time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully
      integrate based on recent histomorphometric studies. Vascularization and trabecular bone
      formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS
      includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite
      (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3
      salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis).
      ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3)
      allowing for the uptake of calcium ions from the physiological solution and releasing
      phosphate and silicate ions which aid in bone formation. A material with such properties will
      substitute bone in a more controlled and effective combination that can be obtained in many
      clinical situations, without the disadvantages found with autograft. ShefaBone has
      demonstrated successful regenerative properties for bony defects. To our knowledge, there is
      no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary
      sinus. This aim of this current study is to compare SCPC to commonly used xenograft material
      in an augmented maxillary sinus.
1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of
           dental implants and subsequent restorations, approximately 20 patients will be randomly
           assigned to receive an augmentation of the maxillary sinus region using either Shefabone
           (synthetic bone) or Bio-Oss (xenograft).

        2. With the use of pre-operative and post-operative limited view CBCT radiography, the
           maxillary sinus bone density will be assessed and compared between the individuals
           receiving Shefabone and the individuals receiving xenograft material.

        3. Histomorphometric analysis will be used to assess, compare and contrast the quality and
           the quantity of the new vital bone cells generated when using these different graft
           materials.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled clinical trial. Entails 2 groups of subjects which will be randomly assigned. Group 1 will be the control group, and group 2 is test group.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Bone Density - Limited View CBCT Measurements
time frame: 5 months
description: Bone density will be measured by limited view CBCT radiography pre- and post-operatively.
measure: Bone Quality
time frame: 5.5 months
description: Bone quality will be measured using histomorphometric analysis.
arm group label: Control Group
arm group type: Other
description: Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.
arm group label: Test Group
arm group type: Experimental
description: The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.
intervention type: Biological
intervention name: Shefabone
description: Silica-calcium phosphate composite.
arm group label: Test Group
intervention type: Biological
intervention name: Bio-Oss
description: Xenograft Bone substitute. Bone from animals.
arm group label: Control Group
other name: Bio-Oss by Geistlich
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohanad Al-Sabbagh, DDS
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Mohanad Al-Sabbagh
investigator title: Professor
mesh term: Bone Resorption
sharing ipd: No
ipd description: Beneficial information for further research around the topic and/or information that may aid/benefit subjects or dentists in treatment may be shared.