<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/NCT03036566</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00081086</org_study_id>
    <nct_id>NCT03036566</nct_id>
  </id_info>
  <brief_title>Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study</brief_title>
  <official_title>Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Lithium Disilicate Fixed Partial Dentures (FPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ivoclar Vivadent AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation will be a clinical trial to study the performance of a high strength&#xD;
      ceramic material for bridges to replace missing teeth. The ceramic material has been approved&#xD;
      by the FDA for patient treatment. A computer technique will be used to make the bridges. The&#xD;
      bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The&#xD;
      bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3&#xD;
      years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure&#xD;
      how well the high strength bridges function over an extended period of time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be composed of 30 bridges placed in adult patients that have been identified&#xD;
      as requiring replacement of a single tooth. All the bridges will be made from the same high&#xD;
      strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All&#xD;
      the crowns will be cemented using the most current marketed version of the manufacturer's&#xD;
      adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation&#xD;
      of the bridge will be completed as well as clinical photographs, an intraoral digital scan,&#xD;
      and impression of the bridge. The purpose of the study is to measure how well the high&#xD;
      strength bridges function over an extended period of time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Loss of funding due to COVID-19&#xD;
  </why_stopped>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">March 5, 2020</completion_date>
  <primary_completion_date type="Actual">March 5, 2020</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>Bridge Failure</measure>
    <time_frame>from delivery of the bridge up to 5 years</time_frame>
    <description>Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bridge Loss of Retention</measure>
    <time_frame>from delivery of the bridge up to 5 years</time_frame>
    <description>Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tooth Sensitivity</measure>
    <time_frame>from delivery of the bridge up to 5 years</time_frame>
    <description>Tooth Sensitivity is evaluated as either &quot;0&quot; if the subject reports that there is NO sensitivity for either tooth with the study bridge, or &quot;1&quot; if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Margin Staining</measure>
    <time_frame>from delivery of the bridge up to 5 years</time_frame>
    <description>Margin Staining is evaluated as either &quot;0&quot; if there is NO staining at the crown margin where it meets the tooth for either tooth supporting the bridge, or &quot;1&quot; if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Missing Tooth</condition>
  <arm_group>
    <arm_group_label>Bridge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lithium disilicate ceramic (Ivoclar)</intervention_name>
    <description>Three unit high strength ceramic bridges replacing a single tooth.</description>
    <arm_group_label>Bridge</arm_group_label>
    <other_name>fixed partial denture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  missing one anterior or premolar tooth that is appropriate for replacement with a&#xD;
             bridge. The second premolar tooth will be the most distal tooth acceptable as a pontic&#xD;
             for inclusion in the study.&#xD;
&#xD;
          -  healthy periodontal status for the adjacent abutment teeth with 1:1 crown:root ratio&#xD;
&#xD;
          -  abutment teeth must be asymptomatic prior to treatment&#xD;
&#xD;
          -  Endodontically treated teeth will be acceptable for abutments as long as nonmetallic&#xD;
             cores can be placed to retain the FPD since the lithium disilicate will be bonded to&#xD;
             the abutments.&#xD;
&#xD;
          -  no more than one bridge will be placed per patient. If a patient presents with more&#xD;
             than one missing teeth acceptable for the study, premolar teeth will be included prior&#xD;
             to anterior teeth. Each bridge will be three units and include only one missing tooth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sensitive abutment teeth&#xD;
&#xD;
          -  teeth with a history of direct or indirect pulp capping procedures&#xD;
&#xD;
          -  patients with significant untreated dental disease to include periodontitis and caries&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  patients with allergies to any material in the study&#xD;
&#xD;
          -  patients unable to return for recall appointments&#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>Dennis J Fasbinder, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>February 4, 2023</results_first_submitted>
  <results_first_submitted_qc>March 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 5, 2023</results_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Dennis J. Fasbinder, DDS</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</mesh_term>
    <mesh_term>Anodontia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lithium Carbonate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 23, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03036566/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bridge</title>
          <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </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="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bridge</title>
          <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Age was not collected from any participant.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bridge Failure</title>
        <description>Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.</description>
        <time_frame>from delivery of the bridge up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bridge</title>
            <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
          </group>
        </group_list>
        <measure>
          <title>Bridge Failure</title>
          <description>Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.</description>
          <units>number of bridges</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bridge Loss of Retention</title>
        <description>Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.</description>
        <time_frame>from delivery of the bridge up to 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bridge</title>
            <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
          </group>
        </group_list>
        <measure>
          <title>Bridge Loss of Retention</title>
          <description>Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.</description>
          <units>number of bridges</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tooth Sensitivity</title>
        <description>Tooth Sensitivity is evaluated as either &quot;0&quot; if the subject reports that there is NO sensitivity for either tooth with the study bridge, or &quot;1&quot; if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.</description>
        <time_frame>from delivery of the bridge up to 5 years</time_frame>
        <population>number of bridges</population>
        <group_list>
          <group group_id="O1">
            <title>Bridge</title>
            <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
          </group>
        </group_list>
        <measure>
          <title>Tooth Sensitivity</title>
          <description>Tooth Sensitivity is evaluated as either &quot;0&quot; if the subject reports that there is NO sensitivity for either tooth with the study bridge, or &quot;1&quot; if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.</description>
          <population>number of bridges</population>
          <units>number of bridges</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Margin Staining</title>
        <description>Margin Staining is evaluated as either &quot;0&quot; if there is NO staining at the crown margin where it meets the tooth for either tooth supporting the bridge, or &quot;1&quot; if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.</description>
        <time_frame>from delivery of the bridge up to 5 years</time_frame>
        <population>number of bridges</population>
        <group_list>
          <group group_id="O1">
            <title>Bridge</title>
            <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
          </group>
        </group_list>
        <measure>
          <title>Margin Staining</title>
          <description>Margin Staining is evaluated as either &quot;0&quot; if there is NO staining at the crown margin where it meets the tooth for either tooth supporting the bridge, or &quot;1&quot; if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.</description>
          <population>number of bridges</population>
          <units>number of bridges</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bridge</title>
          <description>Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
              </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>Dennis J. Fasbinder, DDS</name_or_title>
      <organization>University of Michigan</organization>
      <phone>7346474450</phone>
      <email>djfas@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/NCT03036566
org study id: HUM00081086
nct id: NCT03036566
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This investigation will be a clinical trial to study the performance of a high strength
      ceramic material for bridges to replace missing teeth. The ceramic material has been approved
      by the FDA for patient treatment. A computer technique will be used to make the bridges. The
      bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The
      bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3
      years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure
      how well the high strength bridges function over an extended period of time.
The study will be composed of 30 bridges placed in adult patients that have been identified
      as requiring replacement of a single tooth. All the bridges will be made from the same high
      strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All
      the crowns will be cemented using the most current marketed version of the manufacturer's
      adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation
      of the bridge will be completed as well as clinical photographs, an intraoral digital scan,
      and impression of the bridge. The purpose of the study is to measure how well the high
      strength bridges function over an extended period of time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bridge Failure
time frame: from delivery of the bridge up to 5 years
description: Bridge failure includes fracture of the bridge or loss of the bridge requiring placement of a new bridge at any time between delivery and five years.
measure: Bridge Loss of Retention
time frame: from delivery of the bridge up to 5 years
description: Loss of retention is measured as detachment of the bridge from the teeth without fracture of the bridge requiring recementation of the bridge.
measure: Tooth Sensitivity
time frame: from delivery of the bridge up to 5 years
description: Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for either tooth with the study bridge, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure for either tooth supporting the bridge. The better outcome is to have NO tooth sensitivity.
measure: Margin Staining
time frame: from delivery of the bridge up to 5 years
description: Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth for either tooth supporting the bridge, or "1" if there IS staining at the crown margin where it meets the tooth for either tooth supporting the bridge. The better outcome is to have NO margin staining.
arm group label: Bridge
arm group type: Experimental
description: Three unit high strength ceramic (lithium disilicate/emaxCAD by Ivoclar) bridges replacing a single tooth.
intervention type: Device
intervention name: Lithium disilicate ceramic (Ivoclar)
description: Three unit high strength ceramic bridges replacing a single tooth.
arm group label: Bridge
other name: fixed partial denture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dennis J Fasbinder, DDS
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Dennis J. Fasbinder, DDS
investigator title: Clinical Professor
mesh term: Tooth Loss
mesh term: Anodontia
mesh term: Lithium Carbonate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 