<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/NCT02197312</url>
  </required_header>
  <id_info>
    <org_study_id>T-159</org_study_id>
    <nct_id>NCT02197312</nct_id>
  </id_info>
  <brief_title>NobelProceraTM Bridge Shaded Zirconia</brief_title>
  <official_title>A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia</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>
      Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide&#xD;
      partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a&#xD;
      veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate&#xD;
      after 5 years&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business reasons&#xD;
  </why_stopped>
  <start_date type="Actual">June 18, 2010</start_date>
  <completion_date type="Actual">November 23, 2013</completion_date>
  <primary_completion_date type="Actual">November 23, 2013</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>clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings &quot;R&quot; (excellent) or &quot;S&quot;(acceptable)</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Posterior Bridge Restoration</condition>
  <arm_group>
    <arm_group_label>NobelProcera Bridge Shaded Zirconia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>posterior region</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NobelProcera Bridge Shaded Zirconia</intervention_name>
    <arm_group_label>NobelProcera Bridge Shaded Zirconia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject must be at least 18 (or age of consent), and less than 70 at the time of&#xD;
             inclusion.&#xD;
&#xD;
          -  The subject is healthy and compliant with good oral hygiene&#xD;
&#xD;
          -  The subject is in need of a posterior fixed partial denture restoration 3 or 4 units&#xD;
             distal of the canines in the maxilla or mandible.&#xD;
&#xD;
          -  The subject shall have a stable occlusal relationship with a fully restored, fixed&#xD;
             opposing dentition.&#xD;
&#xD;
          -  Obtained informed consent from the subject prior to the study.&#xD;
&#xD;
          -  No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.&#xD;
&#xD;
          -  Good gingival / periodontal / periapical status of restoring, opposing and adjacent&#xD;
             teeth. Healed situation of soft tissue augmentation is allowed.&#xD;
&#xD;
          -  The subject should be available for the 5-year term of the investigation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is not able to give her/his informed consent to participate.&#xD;
&#xD;
          -  Alcohol or drug abuse as noted in patient records or in patient history.&#xD;
&#xD;
          -  Reason to believe that the treatment might have a negative effect on the patient's&#xD;
             total situation (psychiatric problems), as noted in patient records or in patient&#xD;
             history.&#xD;
&#xD;
          -  An existing condition where acceptable retention of the restoration is impossible to&#xD;
             attain&#xD;
&#xD;
          -  Mobility greater than grade 1 of the tooth to be restored.&#xD;
&#xD;
          -  Pathologic pocket formation of 4 mm or greater around the tooth to be restored&#xD;
&#xD;
          -  Severe bruxism or other destructive habits&#xD;
&#xD;
          -  Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or&#xD;
             attachment loss greater than half of the root length).&#xD;
&#xD;
          -  Health conditions, which do not permit the restorative procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitätsklinikum Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>March 29, 2017</last_update_submitted>
  <last_update_submitted_qc>March 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>yttrium-oxide</keyword>
  <keyword>Y-TZP</keyword>
  <keyword>bridge</keyword>
  <keyword>NobelProcera</keyword>
  <keyword>Shaded Zirconia</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02197312
org study id: T-159
nct id: NCT02197312
lead sponsor: 
has dmc: No
Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide
      partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a
      veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate
      after 5 years
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable)
time frame: yearly up to 5 years
measure: survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region
time frame: yearly up to 5 years
measure: esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey
time frame: yearly up to 5 years
arm group label: NobelProcera Bridge Shaded Zirconia
arm group type: Other
description: posterior region
intervention type: Device
intervention name: NobelProcera Bridge Shaded Zirconia
arm group label: NobelProcera Bridge Shaded Zirconia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor