<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/NCT03036579</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00103921</org_study_id>
    <nct_id>NCT03036579</nct_id>
  </id_info>
  <brief_title>Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study</brief_title>
  <official_title>Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dentsply Sirona Inc.</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 newly developed&#xD;
      high strength ceramic material for crowns. The ceramic has been approved by the FDA for&#xD;
      patient treatment. A computer technique will be used to fabricate the crowns in a single&#xD;
      appointment without the need for a temporary crown or second appointment. Two adhesive resin&#xD;
      cement techniques will be used to hold the crown to the tooth and they will be evaluated for&#xD;
      creating sensitivity to the tooth. The purpose of the study is to measure how well the high&#xD;
      strength crowns function over an extended period of time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be composed of two groups of 50 crowns placed in adult patients that have been&#xD;
      identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per&#xD;
      patient will be completed. All the crowns will be made from the same high strength ceramic&#xD;
      material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two&#xD;
      different processes to create the surface texture and finish for the crown. One group of&#xD;
      Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group&#xD;
      (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive&#xD;
      techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching,&#xD;
      self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand&#xD;
      polished crowns will be cemented using an adhesive bonding technique using Prime &amp; Bond Elect&#xD;
      (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to&#xD;
      be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5&#xD;
      years. At each appointment an examination of the crown will be completed as well as clinical&#xD;
      photographs, an intraoral digital scan, and impression of the crown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID, loss of funding&#xD;
  </why_stopped>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</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>Single (Care Provider)</masking>
    <masking_description>Final surface fabrication was not identified in the treatment process until the crown was milled.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Crown Failure</measure>
    <time_frame>from delivery of the crown up to 3 years</time_frame>
    <description>Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Crown Loss of Retention</measure>
    <time_frame>3 years</time_frame>
    <description>Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tooth Sensitivity</measure>
    <time_frame>3 years</time_frame>
    <description>Tooth Sensitivity is evaluated as either &quot;0&quot; if the subject reports that there is NO sensitivity for the tooth with the study crown, or &quot;1&quot; if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Margin Staining</measure>
    <time_frame>from delivery of the crown up to 3 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, or &quot;1&quot; if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Fractured Tooth</condition>
  <condition>Decayed Tooth</condition>
  <condition>Unsatisfactory Restoration of Tooth</condition>
  <arm_group>
    <arm_group_label>Glazed Fired, Calibra Céram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand Polished, Calibra Universal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Celtra Duo</intervention_name>
    <description>Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
    <arm_group_label>Glazed Fired, Calibra Céram</arm_group_label>
    <arm_group_label>Hand Polished, Calibra Universal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must have at least one carious lesion or defective restoration or fractured tooth in a&#xD;
             molar or premolar&#xD;
&#xD;
          -  reason for restoration should extend more than one-half the intercuspal width of the&#xD;
             tooth requiring a full crown restoration&#xD;
&#xD;
          -  Teeth to be vital and asymptomatic prior to treatment&#xD;
&#xD;
          -  No more than two restorations will be placed per patient. If a patient presents with&#xD;
             more than two acceptable teeth for the study, molar teeth will be included prior to&#xD;
             premolar teeth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Devital or sensitive teeth&#xD;
&#xD;
          -  Teeth with prior endodontic treatment of any kind&#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&#xD;
             rampant caries&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients with a history of allergies to any of the materials to be used in the study&#xD;
&#xD;
          -  Patients unable to return for the 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>January 23, 2023</results_first_submitted>
  <results_first_submitted_qc>March 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2023</results_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 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>
  <keyword>CAD/CAM</keyword>
  <keyword>Ceramic</keyword>
  <keyword>Crown</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Tooth Fractures</mesh_term>
  </condition_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 19, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03036579/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Recall at 5 years not funded by sponsor, therefore data not collected up to 5 years</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Glazed Fired, Calibra Céram</title>
          <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
        </group>
        <group group_id="P2">
          <title>Hand Polished, Calibra Universal</title>
          <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41">some participants had 2 teeth restored with crowns</participants>
                <participants group_id="P2" count="32">some participants had two teeth restored with crowns</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>6 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>1 Year</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>2 Years</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </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="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3 Years</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41">The participant lost to follow up in year 2 participated in year 3 which is why the number of participants to start in year 3 does not equal those who completed year 2.</participants>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </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="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Number of teeth restored with crowns</population>
      <group_list>
        <group group_id="B1">
          <title>Glazed Fired, Calibra Céram</title>
          <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
        </group>
        <group group_id="B2">
          <title>Hand Polished, Calibra Universal</title>
          <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="73"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>number of teeth restored with crowns</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Age data not collected from any participant</description>
          <population>Age data not collected from any participant</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="0"/>
                <count group_id="B2" value="0"/>
                <count group_id="B3" value="0"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>number of teeth restored with crowns</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="50"/>
                <count group_id="B2" value="50"/>
                <count group_id="B3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="41"/>
                <count group_id="B2" value="32"/>
                <count group_id="B3" value="73"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>number of teeth restored with crowns</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="50"/>
                <count group_id="B2" value="50"/>
                <count group_id="B3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="24"/>
                  </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>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="0"/>
                <count group_id="B2" value="0"/>
                <count group_id="B3" value="0"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>number of teeth restored with crowns</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="50"/>
                <count group_id="B2" value="50"/>
                <count group_id="B3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Crown Failure</title>
        <description>Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.</description>
        <time_frame>from delivery of the crown up to 3 years</time_frame>
        <population>teeth restored with crowns</population>
        <group_list>
          <group group_id="O1">
            <title>Glazed Fired, Calibra Céram</title>
            <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
          </group>
          <group group_id="O2">
            <title>Hand Polished, Calibra Universal</title>
            <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
          </group>
        </group_list>
        <measure>
          <title>Crown Failure</title>
          <description>Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.</description>
          <population>teeth restored with crowns</population>
          <units>crowns</units>
          <param>Number</param>
          <units_analyzed>Teeth</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Teeth</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Crown Loss of Retention</title>
        <description>Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.</description>
        <time_frame>3 years</time_frame>
        <population>number of crowns</population>
        <group_list>
          <group group_id="O1">
            <title>Glazed Fired, Calibra Céram</title>
            <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
          </group>
          <group group_id="O2">
            <title>Hand Polished, Calibra Universal</title>
            <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
          </group>
        </group_list>
        <measure>
          <title>Crown Loss of Retention</title>
          <description>Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.</description>
          <population>number of crowns</population>
          <units>crowns</units>
          <param>Number</param>
          <units_analyzed>Teeth</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Teeth</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" 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 the tooth with the study crown, or &quot;1&quot; if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.</description>
        <time_frame>3 years</time_frame>
        <population>number of teeth with crown</population>
        <group_list>
          <group group_id="O1">
            <title>Glazed Fired, Calibra Céram</title>
            <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
          </group>
          <group group_id="O2">
            <title>Hand Polished, Calibra Universal</title>
            <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</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 the tooth with the study crown, or &quot;1&quot; if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.</description>
          <population>number of teeth with crown</population>
          <units>Teeth</units>
          <param>Number</param>
          <units_analyzed>Teeth</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Teeth</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" 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, or &quot;1&quot; if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.</description>
        <time_frame>from delivery of the crown up to 3 years</time_frame>
        <population>number of crowns</population>
        <group_list>
          <group group_id="O1">
            <title>Glazed Fired, Calibra Céram</title>
            <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
          </group>
          <group group_id="O2">
            <title>Hand Polished, Calibra Universal</title>
            <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</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, or &quot;1&quot; if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.</description>
          <population>number of crowns</population>
          <units>crowns</units>
          <param>Number</param>
          <units_analyzed>Teeth</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Teeth</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from baseline to 3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Glazed Fired, Calibra Céram</title>
          <description>Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</description>
        </group>
        <group group_id="E2">
          <title>Hand Polished, Calibra Universal</title>
          <description>Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement&#xD;
Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.</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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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/NCT03036579
org study id: HUM00103921
nct id: NCT03036579
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 newly developed
      high strength ceramic material for crowns. The ceramic has been approved by the FDA for
      patient treatment. A computer technique will be used to fabricate the crowns in a single
      appointment without the need for a temporary crown or second appointment. Two adhesive resin
      cement techniques will be used to hold the crown to the tooth and they will be evaluated for
      creating sensitivity to the tooth. The purpose of the study is to measure how well the high
      strength crowns function over an extended period of time.
The study will be composed of two groups of 50 crowns placed in adult patients that have been
      identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per
      patient will be completed. All the crowns will be made from the same high strength ceramic
      material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two
      different processes to create the surface texture and finish for the crown. One group of
      Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group
      (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive
      techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching,
      self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand
      polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect
      (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to
      be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5
      years. At each appointment an examination of the crown will be completed as well as clinical
      photographs, an intraoral digital scan, and impression of the crown.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
masking description: Final surface fabrication was not identified in the treatment process until the crown was milled.
measure: Crown Failure
time frame: from delivery of the crown up to 3 years
description: Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.
measure: Crown Loss of Retention
time frame: 3 years
description: Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.
measure: Tooth Sensitivity
time frame: 3 years
description: Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.
measure: Margin Staining
time frame: from delivery of the crown up to 3 years
description: Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.
arm group label: Glazed Fired, Calibra Céram
arm group type: Experimental
description: Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement
arm group label: Hand Polished, Calibra Universal
arm group type: Experimental
description: Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement
intervention type: Device
intervention name: Celtra Duo
description: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
arm group label: Glazed Fired, Calibra Céram
arm group label: Hand Polished, Calibra Universal
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: Dental Caries
mesh term: Tooth Fractures
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 