<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/NCT02255149</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00053796</org_study_id>
    <nct_id>NCT02255149</nct_id>
  </id_info>
  <brief_title>A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw</brief_title>
  <official_title>Vertical Ridge Augmentation Using Titanium Mesh and Allograft in Posterior Mandible: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will involve placing donor bone into the back of lower jaw then covering with a&#xD;
      newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it&#xD;
      will be removed. Implants will be placed in the newly formed bone.&#xD;
&#xD;
      The goal of this study is to test how well using a newly designed titanium mesh and bone&#xD;
      particles can grow bone in the back of the lower jaw. The investigators are also checking if&#xD;
      the newly formed bone will stay around implants that will have been in use for 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion Criteria&#xD;
&#xD;
        -  Patients are at least 18 years old&#xD;
&#xD;
        -  At least two adjacent back teeth in the lower jaw are missing&#xD;
&#xD;
        -  No medical contraindication to dental surgery&#xD;
&#xD;
        -  Inadequate vertical ridge height at edentulous region (less than 10mm)&#xD;
&#xD;
      Exclusion Criteria&#xD;
&#xD;
        -  Unstable systemic diseases or conditions that would compromise the healing potential&#xD;
&#xD;
        -  Patients with osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)&#xD;
&#xD;
        -  Patients who are pregnant or expect to get pregnant&#xD;
&#xD;
        -  Patients with unstable dental disease (e.g. caries and periodontitis) in the surgical&#xD;
           sextant&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Height</measure>
    <time_frame>5 months</time_frame>
    <description>Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Alveolar Bone Loss</condition>
  <arm_group>
    <arm_group_label>Bone/Mesh</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Allograft and Titanium mesh will be used to grow jaw bone vertically.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bone/Mesh</intervention_name>
    <description>A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.</description>
    <arm_group_label>Bone/Mesh</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy patients (ASA I or II)&#xD;
&#xD;
          -  Non-smoker or light smokers (&lt; 10 cigarettes per day)&#xD;
&#xD;
          -  Good oral health (FMPS and FMBS &lt;20%)&#xD;
&#xD;
          -  At least two adjacent mandibular posterior teeth are missing&#xD;
&#xD;
          -  Inadequate vertical ridge height at edentulous region (less than 10mm)&#xD;
&#xD;
          -  Missing teeth for ≥ 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable and complicated systemic diseases or chronic disorders precluding surgical&#xD;
             procedures&#xD;
&#xD;
          -  Systemic diseases with compromised healing potentials (Uncontrolled Diabetes Mellitus,&#xD;
             HIV infections, etc.)&#xD;
&#xD;
          -  Bone disorders (Hyperparathyroidism, Osteoporosis, Paget's Disease)&#xD;
&#xD;
          -  Pregnant or expecting to become pregnant&#xD;
&#xD;
          -  Currently smoking (≥ 10 cigarettes/day)&#xD;
&#xD;
          -  Poor oral hygiene (≥20% Modified O'Leary Plaque Index)&#xD;
&#xD;
          -  Severe grinding, clenching, TMJ disorder&#xD;
&#xD;
          -  Untreated dental disease (periodontitis, caries, abscesses) in the research quadrant&#xD;
&#xD;
          -  Teeth exhibiting periapical pathology or purulence (symptomatic) in the research&#xD;
             quadrant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsun-Liang Chan, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <results_reference>
    <citation>Chan HL, Benavides E, Tsai CY, Wang HL. A Titanium Mesh and Particulate Allograft for Vertical Ridge Augmentation in the Posterior Mandible: A Pilot Study. Int J Periodontics Restorative Dent. 2015 Jul-Aug;35(4):515-22. doi: 10.11607/prd.1980.</citation>
    <PMID>26133141</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>March 17, 2016</results_first_submitted>
  <results_first_submitted_qc>March 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 19, 2016</results_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Hsun-Liang Chan</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bone/Mesh</title>
          <description>Allograft and Titanium mesh will be used to grow jaw bone vertically.&#xD;
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by PI</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Implant Failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bone/Mesh</title>
          <description>Allograft and Titanium mesh will be used to grow jaw bone vertically.&#xD;
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&gt;=18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bone height</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.8" lower_limit="7.2" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bone Height</title>
        <description>Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.</description>
        <time_frame>5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bone/Mesh</title>
            <description>Allograft and Titanium mesh will be used to grow jaw bone vertically.&#xD;
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Height</title>
          <description>Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="8.0" upper_limit="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bone/Mesh</title>
          <description>Allograft and Titanium mesh will be used to grow jaw bone vertically.&#xD;
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxic Tissue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Soreness on Tongue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Throbbing Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Implant Failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mesh Exposure/Removal</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lack of Bone Growth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Wound Opening at Mesh site</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Soft Tissue Dehiscence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Hsun-Liang Chan</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-763-3325</phone>
      <email>hlchan@umich.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02255149
org study id: HUM00053796
nct id: NCT02255149
lead sponsor: 
has dmc: Yes
This study will involve placing donor bone into the back of lower jaw then covering with a
      newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it
      will be removed. Implants will be placed in the newly formed bone.

      The goal of this study is to test how well using a newly designed titanium mesh and bone
      particles can grow bone in the back of the lower jaw. The investigators are also checking if
      the newly formed bone will stay around implants that will have been in use for 12 months.
Inclusion Criteria

        -  Patients are at least 18 years old

        -  At least two adjacent back teeth in the lower jaw are missing

        -  No medical contraindication to dental surgery

        -  Inadequate vertical ridge height at edentulous region (less than 10mm)

      Exclusion Criteria

        -  Unstable systemic diseases or conditions that would compromise the healing potential

        -  Patients with osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)

        -  Patients who are pregnant or expect to get pregnant

        -  Patients with unstable dental disease (e.g. caries and periodontitis) in the surgical
           sextant
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bone Height
time frame: 5 months
description: Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.
arm group label: Bone/Mesh
arm group type: Experimental
description: Allograft and Titanium mesh will be used to grow jaw bone vertically.
intervention type: Device
intervention name: Bone/Mesh
description: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
arm group label: Bone/Mesh
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hsun-Liang Chan, DDS, MS
role: Principal Investigator
affiliation: University of Michigan
citation: Chan HL, Benavides E, Tsai CY, Wang HL. A Titanium Mesh and Particulate Allograft for Vertical Ridge Augmentation in the Posterior Mandible: A Pilot Study. Int J Periodontics Restorative Dent. 2015 Jul-Aug;35(4):515-22. doi: 10.11607/prd.1980.
PMID: 26133141
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Hsun-Liang Chan
investigator title: Assistant Professor
mesh term: Alveolar Bone Loss
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 