<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/NCT02186808</url>
  </required_header>
  <id_info>
    <org_study_id>T-116</org_study_id>
    <nct_id>NCT02186808</nct_id>
  </id_info>
  <brief_title>T-116_Procera-Bridge Zirconia - A Clinical Study</brief_title>
  <official_title>Procera-Bridge Zirconia - A Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nobel Biocare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nobel Biocare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate the clinical performance of Procera® Bridge&#xD;
      Zirconia veneered with NobelRondo Zirconia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was designed to be an open, 5-year, prospective, multi-center clinical post-market&#xD;
      study. The objectives of this clinical study were that industrial centrally produced 3- or&#xD;
      4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in&#xD;
      combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings&#xD;
      (90% R+S) and a sufficient survival rate after 1 and 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2005</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Success Rate of Bridge Procera Bridge Zirconia</measure>
    <time_frame>prosthesis delivery, 1 year</time_frame>
    <description>The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success Rate of Bridge Procera Bridge Zirconia</measure>
    <time_frame>prosthesis delivery, 5 years</time_frame>
    <description>The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Partial Edentulism</condition>
  <arm_group>
    <arm_group_label>Procera® Bridge Zirconia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Procera® Bridge Zirconia</intervention_name>
    <description>Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.</description>
    <arm_group_label>Procera® Bridge Zirconia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any&#xD;
             position of the maxilla or the mandible&#xD;
&#xD;
          -  Indication: same indication as for metal supported bridges&#xD;
&#xD;
          -  Obtained informed consent from the patient&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Currently known alcohol, drug or medication abuse, judged by the investigator, which&#xD;
             might influence the follow-up program&#xD;
&#xD;
          -  Patients where a bridge part connection area of 3 mm of diameter is not possible to&#xD;
             obtain (short clinical crowns)&#xD;
&#xD;
          -  Mobility of the abutment teeth exceeding grade I&#xD;
&#xD;
          -  Patients with pathologic pocket formation at abutment teeth&#xD;
&#xD;
          -  Patients with complete dentures in the opposing jaw&#xD;
&#xD;
          -  Patients with a removable partial denture in the same jaw&#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>
  <reference>
    <citation>Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.</citation>
  </reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>March 23, 2016</results_first_submitted>
  <results_first_submitted_qc>March 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 25, 2016</results_first_posted>
  <last_update_submitted>September 23, 2016</last_update_submitted>
  <last_update_submitted_qc>September 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Procera® Bridge Zirconia</title>
          <description>Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.&#xD;
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Procera® Bridge Zirconia</title>
          <description>Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.&#xD;
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <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="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Success Rate of Bridge Procera Bridge Zirconia</title>
        <description>The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.</description>
        <time_frame>prosthesis delivery, 1 year</time_frame>
        <population>78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Procera® Bridge Zirconia</title>
            <description>Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.&#xD;
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate of Bridge Procera Bridge Zirconia</title>
          <description>The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.</description>
          <population>78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.</population>
          <units>percentage of successful implants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>bridges</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Success Rate of Bridge Procera Bridge Zirconia</title>
        <description>The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.</description>
        <time_frame>prosthesis delivery, 5 years</time_frame>
        <population>5 year data. Not all initially treated patients could be followed over the 5 years.</population>
        <group_list>
          <group group_id="O1">
            <title>Procera® Bridge Zirconia</title>
            <description>Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.&#xD;
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate of Bridge Procera Bridge Zirconia</title>
          <description>The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.</description>
          <population>5 year data. Not all initially treated patients could be followed over the 5 years.</population>
          <units>percentage of successful implants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of Bridges analyzed</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Procera® Bridge Zirconia</title>
          <description>Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.&#xD;
Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrhytmia</sub_title>
                <description>Deceased, no evidence for a device related complication is reported.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Heart disease</sub_title>
                <description>Deceased, no evidence for a device related complication is reported.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <description>Deceased, no evidence for a device related complication is reported.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>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="38" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Porcelain fractures</sub_title>
                <counts group_id="E1" events="27" subjects_affected="22" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>occlusal adjustments</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Periodontal problems</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="80"/>
              </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>Head of Clinical Trial Management</name_or_title>
      <organization>Nobel Biocare</organization>
      <phone>+41 43 211 42 00</phone>
      <email>isabelle.arrighi@nobelbiocare.com</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/NCT02186808
org study id: T-116
nct id: NCT02186808
lead sponsor: 
has dmc: No
The objective of the study is to evaluate the clinical performance of Procera® Bridge
      Zirconia veneered with NobelRondo Zirconia.
The study was designed to be an open, 5-year, prospective, multi-center clinical post-market
      study. The objectives of this clinical study were that industrial centrally produced 3- or
      4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in
      combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings
      (90% R+S) and a sufficient survival rate after 1 and 5 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success Rate of Bridge Procera Bridge Zirconia
time frame: prosthesis delivery, 1 year
description: The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.
measure: Success Rate of Bridge Procera Bridge Zirconia
time frame: prosthesis delivery, 5 years
description: The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.
arm group label: Procera® Bridge Zirconia
arm group type: Other
description: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
intervention type: Device
intervention name: Procera® Bridge Zirconia
description: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
arm group label: Procera® Bridge Zirconia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 