<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/NCT02220764</url>
  </required_header>
  <id_info>
    <org_study_id>W-008</org_study_id>
    <nct_id>NCT02220764</nct_id>
  </id_info>
  <brief_title>Zirconia Based Fixed Dental Prostheses</brief_title>
  <official_title>Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this prospective clinical study is to investigate the differences in the&#xD;
      complication rates between tooth- and implant- supported zirconia based fixed dental&#xD;
      prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference&#xD;
      in the complication rates between implant- supported and tooth- supported zirconia FDPs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and&#xD;
      implant-supported FDPs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Fixed Dental Prostheses (FDPs) With Failure</measure>
    <time_frame>3 years</time_frame>
    <description>&quot;Failure&quot; was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Fixed Dental Prostheses (FDPs) With Chip/s</measure>
    <time_frame>3 years</time_frame>
    <description>Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of of Fixed Dental Prostheses (FDPs) With Rough Surface</measure>
    <time_frame>3 years</time_frame>
    <description>Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Zirconia Based Fixed Dental Prostheses</condition>
  <arm_group>
    <arm_group_label>Tooth-supported</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Long-span tooth-supported zirconia based fixed dental prostheses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Implant-supported</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Long-span implant-supported zirconia based fixed dental prostheses</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Teeth abutment</intervention_name>
    <arm_group_label>Tooth-supported</arm_group_label>
    <other_name>Zenotec system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implant abutments</intervention_name>
    <arm_group_label>Implant-supported</arm_group_label>
    <other_name>Zenotec system</other_name>
    <other_name>Wital (Implant system)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
          -  Missing of at least two adjacent teeth in the maxilla or mandibular&#xD;
&#xD;
          -  Sufficient oral hygiene&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Addiction to alcohol or drugs&#xD;
&#xD;
          -  Severe craniomandibular disorders&#xD;
&#xD;
          -  Severe systematic diseases&#xD;
&#xD;
          -  Patients unable or unwilling to sign the informed consent form&#xD;
&#xD;
          -  Untreated periodontitis&#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>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>March 4, 2015</results_first_submitted>
  <results_first_submitted_qc>March 23, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 24, 2015</results_first_posted>
  <last_update_submitted>March 23, 2015</last_update_submitted>
  <last_update_submitted_qc>March 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prospective study</keyword>
  <keyword>chipping</keyword>
  <keyword>survival rate</keyword>
  <keyword>fracture resistance</keyword>
  <keyword>zirconia</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tooth-supported</title>
          <description>Long-span tooth-supported zirconia based fixed dental prostheses&#xD;
Teeth abutment</description>
        </group>
        <group group_id="P2">
          <title>Implant-supported</title>
          <description>Long-span implant-supported zirconia based fixed dental prostheses&#xD;
Implant abutments</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <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="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</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_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tooth-supported</title>
          <description>Long-span tooth-supported zirconia based fixed dental prostheses&#xD;
Teeth abutment</description>
        </group>
        <group group_id="B2">
          <title>Implant-supported</title>
          <description>Long-span implant-supported zirconia based fixed dental prostheses&#xD;
Implant abutments</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="24"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.2" spread="9.01"/>
                    <measurement group_id="B2" value="53.9" spread="10.9"/>
                    <measurement group_id="B3" value="54.9" spread="9.4"/>
                  </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="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Fixed Dental Prostheses (FDPs) With Failure</title>
        <description>&quot;Failure&quot; was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tooth-supported</title>
            <description>Long-span tooth-supported zirconia based fixed dental prostheses&#xD;
Teeth abutment</description>
          </group>
          <group group_id="O2">
            <title>Implant-supported</title>
            <description>Long-span implant-supported zirconia based fixed dental prostheses&#xD;
Implant abutments</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Fixed Dental Prostheses (FDPs) With Failure</title>
          <description>&quot;Failure&quot; was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.</description>
          <units>FDPs with failure</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Fixed Dental Prostheses (FDPs) With Chip/s</title>
        <description>Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tooth-supported</title>
            <description>Long-span tooth-supported zirconia based fixed dental prostheses&#xD;
Teeth abutment</description>
          </group>
          <group group_id="O2">
            <title>Implant-supported</title>
            <description>Long-span implant-supported zirconia based fixed dental prostheses&#xD;
Implant abutments</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Fixed Dental Prostheses (FDPs) With Chip/s</title>
          <description>Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.</description>
          <units>FDPs with chip/s</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of of Fixed Dental Prostheses (FDPs) With Rough Surface</title>
        <description>Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.</description>
        <time_frame>3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tooth-supported</title>
            <description>Long-span tooth-supported zirconia based fixed dental prostheses&#xD;
Teeth abutment</description>
          </group>
          <group group_id="O2">
            <title>Implant-supported</title>
            <description>Long-span implant-supported zirconia based fixed dental prostheses&#xD;
Implant abutments</description>
          </group>
        </group_list>
        <measure>
          <title>Number of of Fixed Dental Prostheses (FDPs) With Rough Surface</title>
          <description>Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.</description>
          <units>FDPs with rough surface</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Tooth-supported</title>
          <description>Long-span tooth-supported zirconia based fixed dental prostheses&#xD;
Teeth abutment</description>
        </group>
        <group group_id="E2">
          <title>Implant-supported</title>
          <description>Long-span implant-supported zirconia based fixed dental prostheses&#xD;
Implant abutments</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Konstantinidis Ioannis</name_or_title>
      <organization>Zahnärztliche Prothetik</organization>
      <phone>+49 351 458 4231</phone>
      <email>ioannis.konstantinidis@uniklinikum-dresden.de</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/NCT02220764
org study id: W-008
nct id: NCT02220764
lead sponsor: 
has dmc: No
The objective of this prospective clinical study is to investigate the differences in the
      complication rates between tooth- and implant- supported zirconia based fixed dental
      prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference
      in the complication rates between implant- supported and tooth- supported zirconia FDPs.
The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and
      implant-supported FDPs.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Fixed Dental Prostheses (FDPs) With Failure
time frame: 3 years
description: "Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.
measure: Number of Fixed Dental Prostheses (FDPs) With Chip/s
time frame: 3 years
description: Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.
measure: Number of of Fixed Dental Prostheses (FDPs) With Rough Surface
time frame: 3 years
description: Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.
arm group label: Tooth-supported
arm group type: Experimental
description: Long-span tooth-supported zirconia based fixed dental prostheses
arm group label: Implant-supported
arm group type: Active Comparator
description: Long-span implant-supported zirconia based fixed dental prostheses
intervention type: Device
intervention name: Teeth abutment
arm group label: Tooth-supported
other name: Zenotec system
intervention type: Device
intervention name: Implant abutments
arm group label: Implant-supported
other name: Zenotec system
other name: Wital (Implant system)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 