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/NCT06012071</url>
    </required_header>
    <id_info>
      <org_study_id>ZIRCIMPL001</org_study_id>
      <nct_id>NCT06012071</nct_id>
    </id_info>
    <brief_title>Two-piece Zirconia Implants With Two Various Platforms</brief_title>
    <acronym>ZircImpl</acronym>
    <official_title>Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Ljubljana</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Ljubljana</source>
    <oversight_info>
      <has_dmc>Yes</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>
        24 patients with missing premolar teeth and healed sockets will be recruited. They will be&#xD;
        randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm&#xD;
        long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with&#xD;
        International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be&#xD;
        supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and&#xD;
        bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 3, 2022</start_date>
    <completion_date type="Anticipated">December 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 3, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Crestal bone loss (mm)</measure>
      <time_frame>baseline, 1-year, 3-years, 5 years</time_frame>
      <description>Loss of marginal bone in mm</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Probing depth (mm)</measure>
      <time_frame>baseline, 1-year, 3-years, 5 years</time_frame>
      <description>Probing pocket depth measured with periodontal probe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on probing (BOP)</measure>
      <time_frame>baseline, 1-year, 3-years, 5 years</time_frame>
      <description>Bleeding provoked by probing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volumetric tissue change</measure>
      <time_frame>1-year, 3-years, 5 years</time_frame>
      <description>Sequential intraoral scanning</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Edentulous Alveolar Ridge</condition>
    <arm_group>
      <arm_group_label>Tissue-level</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bone-level</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Zirconia dental implants</intervention_name>
      <description>Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.</description>
      <arm_group_label>Bone-level</arm_group_label>
      <arm_group_label>Tissue-level</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Single missing maxillary premolar&#xD;
  &#xD;
            -  Occlusal stability&#xD;
  &#xD;
            -  Good oral hygiene&#xD;
  &#xD;
            -  Good general health&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Oral mucosa pathology&#xD;
  &#xD;
            -  Dental caries&#xD;
  &#xD;
            -  Active periodontitis (non-treated)&#xD;
  &#xD;
            -  Systemic diseases and conditions that affect healing or immune capacity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rok Gašperšič, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>faculty of medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rok Gašperšič, PhD</last_name>
      <phone>0038615224998</phone>
      <email>rok.gaspersic@mf.uni-lj.si</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Medical Centre</name>
        <address>
          <city>Ljubljana</city>
          <zip>1000</zip>
          <country>Slovenia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rok Gašperšič, PhD</last_name>
        <phone>0038615224889</phone>
        <email>rok.gaspersic@mf.uni-lj.si</email>
      </contact>
    </location>
    <location_countries>
      <country>Slovenia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dental implants</keyword>
    <keyword>zirconia</keyword>
    <keyword>two-piece</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mouth, Edentulous</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06012071
  org study id: ZIRCIMPL001
  nct id: NCT06012071
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  24 patients with missing premolar teeth and healed sockets will be recruited. They will be
        randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm
        long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with
        International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be
        supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and
        bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Crestal bone loss (mm)
  time frame: baseline, 1-year, 3-years, 5 years
  description: Loss of marginal bone in mm
  measure: Probing depth (mm)
  time frame: baseline, 1-year, 3-years, 5 years
  description: Probing pocket depth measured with periodontal probe
  measure: Bleeding on probing (BOP)
  time frame: baseline, 1-year, 3-years, 5 years
  description: Bleeding provoked by probing
  measure: Volumetric tissue change
  time frame: 1-year, 3-years, 5 years
  description: Sequential intraoral scanning
  arm group label: Tissue-level
  arm group type: Active Comparator
  description: Two-piece zirconia implants with tissue-level platform will be supplied to the single gap premolar regions in maxillae.
  arm group label: Bone-level
  arm group type: Experimental
  description: Two-piece zirconia implants with bone-level platforms will be supplied to the single gap premolar regions in maxillae.
  intervention type: Device
  intervention name: Zirconia dental implants
  description: Dental implants produced from zirconia material, either wit tissue-level or bone-level platform.
  arm group label: Bone-level
  arm group label: Tissue-level
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rok Gašperšič, PhD
  role: Principal Investigator
  affiliation: faculty of medicine
  last name: Rok Gašperšič, PhD
  phone: 0038615224998
  email: rok.gaspersic@mf.uni-lj.si
  facility: 
  status: Recruiting
  contact: 
  country: Slovenia
  responsible party type: Sponsor
  mesh term: Mouth, Edentulous
  sharing ipd: No