<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/NCT02186912</url>
  </required_header>
  <id_info>
    <org_study_id>T-185</org_study_id>
    <nct_id>NCT02186912</nct_id>
  </id_info>
  <brief_title>All-On-4® Treatment Concept</brief_title>
  <official_title>A Clinical Evaluation of All-On-4® Treatment Concept in the Mandible or Maxilla on 4 NobelActive®Implants With a Fixed NobelProcera® Implant Bridge</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>
      Indication : edentulous patients To evaluate and compare the marginal bone level change&#xD;
      around tilted and straight NobelActive implants placed in healed sites with&#xD;
      All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge&#xD;
      (fixed) in the mandible and maxilla.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study stopped as the performance of the study showed insufficient patient recruitment.&#xD;
  </why_stopped>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bone level change around tilted and straight implants</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>cumulative survival rate (CSR)</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life</measure>
    <time_frame>yearly up to 5 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Edentulous</condition>
  <arm_group>
    <arm_group_label>mandible</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nobel Active Nobel Procera IBO</description>
  </arm_group>
  <arm_group>
    <arm_group_label>maxilla</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nobel Active Nobel Procera IBO</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nobel Active, Nobel Procera IBO</intervention_name>
    <arm_group_label>mandible</arm_group_label>
    <arm_group_label>maxilla</arm_group_label>
    <other_name>Nobel Active implants</other_name>
    <other_name>Implant bar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The subject is at least 18 years of age (or age of consent) and has passed secession of&#xD;
        growth&#xD;
&#xD;
        Obtained informed consent from the subject&#xD;
&#xD;
        Edentulous mandible or maxilla providing sufficient bone whereas a fixed NobelProceraTM&#xD;
        Implant bridge on four (4) implants is regarded as an appropriate treatment solution&#xD;
&#xD;
        The subject has an osseous architecture enough to receive four implants and a sufficient&#xD;
        amount of bone for placing in healed sites implants with a length of at least 8 mm&#xD;
&#xD;
        The implant site is free from infection and extraction remnants Implants will be placed in&#xD;
        healed sites.&#xD;
&#xD;
        Good gingival / periodontal / peri-apical status of opposing teeth/implants&#xD;
&#xD;
        The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be&#xD;
        achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or&#xD;
        implant based&#xD;
&#xD;
        The subjects as well as the implant site(s) fulfill the criteria for immediate loading.&#xD;
&#xD;
        The subject is in such a physical and mental condition that a 5-year follow-up period can&#xD;
        be carried out without foreseeable problems The subject is available for the 5-year term of&#xD;
        the investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The subject is not able to give her/his informed consent of participating&#xD;
&#xD;
        Health conditions, which do not permit the surgical (including anesthesia) or restorative&#xD;
        procedure&#xD;
&#xD;
        Reason to believe that the treatment might have a negative effect on the subject's overall&#xD;
        situation (psychiatric problems), as noted in subject records or in subject history Any&#xD;
        disorders in the planned implant area such as previous tumors, chronic bone disease or&#xD;
        previous irradiation in the head/neck area&#xD;
&#xD;
        Alcohol or drug abuse as noted in subject records or in subject history Smoking of &gt;10&#xD;
        cigarettes/day&#xD;
&#xD;
        Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of&#xD;
        neglecting doctor's recommendations regarding treatment, food and alcohol intake&#xD;
&#xD;
        Pathologic occlusion, e.g. severe bruxism or other destructive habits&#xD;
&#xD;
        Lack of opposing dentition or unstable occlusion&#xD;
&#xD;
        Ongoing infections, endodontic or periodontal problems in opposing teeth or implants&#xD;
&#xD;
        Subject shows an unacceptable oral hygiene&#xD;
&#xD;
        Subject has allergic or adverse reactions to the restorative material.&#xD;
&#xD;
        Bone augmentation of more than 3mm vertical height performed less than 6 months prior to&#xD;
        planned implant placement.&#xD;
&#xD;
        Bis-phosphonate therapy&#xD;
&#xD;
        Implant insertion torque is &lt;35 Ncm or &gt;70 Ncm&#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>
  <location>
    <facility>
      <name>Universitätsmedizin Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland-Pfalz</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 8, 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>
  <last_update_submitted>April 4, 2016</last_update_submitted>
  <last_update_submitted_qc>April 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>edentulous</keyword>
  <keyword>Nobel Active</keyword>
  <keyword>Nobel Procera</keyword>
  <keyword>IBO</keyword>
  <keyword>CAD/CAM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186912
org study id: T-185
nct id: NCT02186912
lead sponsor: 
has dmc: No
Indication : edentulous patients To evaluate and compare the marginal bone level change
      around tilted and straight NobelActive implants placed in healed sites with
      All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge
      (fixed) in the mandible and maxilla.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: bone level change around tilted and straight implants
time frame: yearly up to 5 years
measure: cumulative survival rate (CSR)
time frame: yearly up to 5 years
measure: Quality of Life
time frame: yearly up to 5 years
arm group label: mandible
arm group type: Experimental
description: Nobel Active Nobel Procera IBO
arm group label: maxilla
arm group type: Experimental
description: Nobel Active Nobel Procera IBO
intervention type: Device
intervention name: Nobel Active, Nobel Procera IBO
arm group label: mandible
arm group label: maxilla
other name: Nobel Active implants
other name: Implant bar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Mouth, Edentulous