<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/NCT02188212</url>
  </required_header>
  <id_info>
    <org_study_id>T-158</org_study_id>
    <nct_id>NCT02188212</nct_id>
  </id_info>
  <brief_title>Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD</brief_title>
  <official_title>A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProceraTM Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD on Molars</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>
      Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult&#xD;
      patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70&#xD;
      years, provided they fulfill the inclusion criteria and need two single tooth restorations on&#xD;
      contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM&#xD;
      Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium&#xD;
      disilicate on the 1st or 2nd molar randomly allocated to the same tooth position&#xD;
      contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after&#xD;
      receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as&#xD;
      possible adverse events, will be carefully monitored during the entire investigation period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">July 2014</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>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>To compare the longevity of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical behaviour (CDA Index, soft tissue behavior) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>survival rate</measure>
    <time_frame>yearly, up to 5 years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Partial Edentulism</condition>
  <arm_group>
    <arm_group_label>NobelProcera Crown Shaded Zirconia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>NobelProcera Crown Shaded Zirconia molar</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NobelProcera Crown Shaded Zirconia</intervention_name>
    <arm_group_label>NobelProcera Crown 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 at least two paired contalateral single-tooth full coverage&#xD;
             molar restorations in the maxilla and/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.&#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 is 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 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 (no attached gingiva on the buccal side&#xD;
             of the tooth).&#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>
  <overall_official>
    <last_name>Stefan Wolfarth, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aachen, Germany</affiliation>
  </overall_official>
  <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>July 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02188212
org study id: T-158
nct id: NCT02188212
lead sponsor: 
has dmc: No
Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult
      patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70
      years, provided they fulfill the inclusion criteria and need two single tooth restorations on
      contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM
      Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium
      disilicate on the 1st or 2nd molar randomly allocated to the same tooth position
      contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after
      receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as
      possible adverse events, will be carefully monitored during the entire investigation period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To compare the longevity of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.
time frame: yearly up to 5 years
measure: Clinical behaviour (CDA Index, soft tissue behavior) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.
time frame: yearly up to 5 years
measure: survival rate
time frame: yearly, up to 5 years
arm group label: NobelProcera Crown Shaded Zirconia
arm group type: Other
description: NobelProcera Crown Shaded Zirconia molar
intervention type: Device
intervention name: NobelProcera Crown Shaded Zirconia
arm group label: NobelProcera Crown Shaded Zirconia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan Wolfarth, Prof
role: Principal Investigator
affiliation: University of Aachen, Germany
facility: 
country: Germany
responsible party type: Sponsor