xml: <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/NCT06007365</url>
    </required_header>
    <id_info>
      <org_study_id>Z-Systems Registry Z5m</org_study_id>
      <nct_id>NCT06007365</nct_id>
    </id_info>
    <brief_title>Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry</brief_title>
    <official_title>Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Z-Systems</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Z-Systems</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Commercially pure (CP) titanium is the gold standard to produce dental implants because it&#xD;
        has a huge volume of scientific publications over a period of more than 50 years, it is cheap&#xD;
        and simple to produce (i.e., making dental implants economically &quot;affordable&quot;) and comes in&#xD;
        numerous specitic designs of screws tor various indications. That is why more than 95% of the&#xD;
        implant market 5 dominated by titanlum.&#xD;
  &#xD;
        However, there is an innovation trend to manufacture implants from more inert and&#xD;
        biocompatible materials. Ceramic implants represent a valuable alternative for expanding the&#xD;
        patient base of clinicians, especially in cases with challenging aesthetic demand.&#xD;
        Furthermore, there has been a significant increase in the number of patients requesting&#xD;
        metal-free dentistry or bio-holistic implant treatments.&#xD;
  &#xD;
        In the past, ceramics were often branded as &quot;inferior&quot; quality due to its reputation as being&#xD;
        brittle but the growing volume of scientific publications specifically an zirconia are&#xD;
        demonstrating that lt is comparable in fracture-strength with titanium implants. There is a&#xD;
        clear market niche for zirconia implants, especially in cases of:&#xD;
  &#xD;
          -  Aesthetic reconstructions in the anterior region, especially in patients with a thin&#xD;
             gingival biotype&#xD;
  &#xD;
          -  Gingival recessions where a white colored implant is a great advantage&#xD;
  &#xD;
          -  For patients with a titanium intolerance/sensitivity&#xD;
  &#xD;
          -  For patients who prefer a bio-holistic/metal-free dental approach.&#xD;
  &#xD;
        Today, clinicians are asking tor long-term clinical results of zirconia as a dental implant&#xD;
        material. Therefore, Z-Systems AG is conducting this zirconia dental implant registry. A&#xD;
        registry design was chosen because it will capture long-term benefits/risks from clinical&#xD;
        routine without patient selection.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">September 2029</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>Absence of persistent subjective complaints</measure>
      <time_frame>12 months post-loading final prostheis</time_frame>
      <description>Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of peri-implant infection</measure>
      <time_frame>12 months post-loading final prostheis</time_frame>
      <description>Absence of peri-implant infection with suppuration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Absence of mobility</measure>
      <time_frame>12 months post-loading final prostheis</time_frame>
      <description>Absence of mobility of dental implant</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs)</measure>
      <time_frame>At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)</time_frame>
      <description>Secondary Safety Outcome is frequency of occurrence of device related Adverse Device Events (ADEs), Serious Device Events (SADEs). Measured by asking patient if any adverse events occured since last follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory outcomes - complaints and incidence</measure>
      <time_frame>At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)</time_frame>
      <description>Rate of complaints and incidents related to the medical device during the whole registry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory outcomes - clinical satisfaction</measure>
      <time_frame>At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)</time_frame>
      <description>Clinical satisfaction measured on a Likert scale: 1 to 6, with 1 being &quot;not satisfied at all&quot; to 6 being &quot;highly satisfied.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory outcomes - patient satisfaction</measure>
      <time_frame>At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)</time_frame>
      <description>The patient's assessment of function and aesthetics is recorded by his/her assessment of function, aesthetic appearance, implants, speech and self-confidence. The parameters are assessed by rating the degree of satisfaction on a 100 mm Visual Analogue Scale (VAS).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Missing Teeth</condition>
    <arm_group>
      <arm_group_label>Z5m Dental Implants</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Z5m Dental Implants</intervention_name>
      <description>This is an observational study, collecting data on the use of Z5m Dental Implants.</description>
      <arm_group_label>Z5m Dental Implants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patient population is anyone needing to have their missing teeth replaced.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the&#xD;
               Z-Systems Z5m product group&#xD;
  &#xD;
            -  Patient has signed Informed Consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Inability to give consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jochen Mellinghoff, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Z-Systems</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nutcha Bürki, PhD</last_name>
      <phone>+41 62 531 69 04</phone>
      <email>nutcha.buerki@zsystems.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Praxis am Klosterplatz</name>
        <address>
          <city>Olten</city>
          <zip>4600</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luca Egloff, Dr. med. dent.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tooth Loss</mesh_term>
      <mesh_term>Anodontia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007365
  org study id: Z-Systems Registry Z5m
  nct id: NCT06007365
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Commercially pure (CP) titanium is the gold standard to produce dental implants because it
        has a huge volume of scientific publications over a period of more than 50 years, it is cheap
        and simple to produce (i.e., making dental implants economically "affordable") and comes in
        numerous specitic designs of screws tor various indications. That is why more than 95% of the
        implant market 5 dominated by titanlum.
  
        However, there is an innovation trend to manufacture implants from more inert and
        biocompatible materials. Ceramic implants represent a valuable alternative for expanding the
        patient base of clinicians, especially in cases with challenging aesthetic demand.
        Furthermore, there has been a significant increase in the number of patients requesting
        metal-free dentistry or bio-holistic implant treatments.
  
        In the past, ceramics were often branded as "inferior" quality due to its reputation as being
        brittle but the growing volume of scientific publications specifically an zirconia are
        demonstrating that lt is comparable in fracture-strength with titanium implants. There is a
        clear market niche for zirconia implants, especially in cases of:
  
          -  Aesthetic reconstructions in the anterior region, especially in patients with a thin
             gingival biotype
  
          -  Gingival recessions where a white colored implant is a great advantage
  
          -  For patients with a titanium intolerance/sensitivity
  
          -  For patients who prefer a bio-holistic/metal-free dental approach.
  
        Today, clinicians are asking tor long-term clinical results of zirconia as a dental implant
        material. Therefore, Z-Systems AG is conducting this zirconia dental implant registry. A
        registry design was chosen because it will capture long-term benefits/risks from clinical
        routine without patient selection.
  observational model: Cohort
  time perspective: Other
  measure: Absence of persistent subjective complaints
  time frame: 12 months post-loading final prostheis
  description: Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia
  measure: Absence of peri-implant infection
  time frame: 12 months post-loading final prostheis
  description: Absence of peri-implant infection with suppuration
  measure: Absence of mobility
  time frame: 12 months post-loading final prostheis
  description: Absence of mobility of dental implant
  measure: Frequency of occurrence of device related Adverse Device Events (ADEs) and Serious Adverse Device Events (SADEs)
  time frame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
  description: Secondary Safety Outcome is frequency of occurrence of device related Adverse Device Events (ADEs), Serious Device Events (SADEs). Measured by asking patient if any adverse events occured since last follow-up.
  measure: Exploratory outcomes - complaints and incidence
  time frame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
  description: Rate of complaints and incidents related to the medical device during the whole registry.
  measure: Exploratory outcomes - clinical satisfaction
  time frame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
  description: Clinical satisfaction measured on a Likert scale: 1 to 6, with 1 being "not satisfied at all" to 6 being "highly satisfied.
  measure: Exploratory outcomes - patient satisfaction
  time frame: At implant surgery, up to 3 months, 6 months, 1-5 years post-loading with the final prosthesis (i.e., at every follow-up visit after prosthetic restoration)
  description: The patient's assessment of function and aesthetics is recorded by his/her assessment of function, aesthetic appearance, implants, speech and self-confidence. The parameters are assessed by rating the degree of satisfaction on a 100 mm Visual Analogue Scale (VAS).
  arm group label: Z5m Dental Implants
  intervention type: Device
  intervention name: Z5m Dental Implants
  description: This is an observational study, collecting data on the use of Z5m Dental Implants.
  arm group label: Z5m Dental Implants
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jochen Mellinghoff, PhD
  role: Study Director
  affiliation: Z-Systems
  last name: Nutcha Bürki, PhD
  phone: +41 62 531 69 04
  email: nutcha.buerki@zsystems.com
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Tooth Loss
  mesh term: Anodontia
  sharing ipd: Undecided