<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/NCT03283241</url>
  </required_header>
  <id_info>
    <org_study_id>ADD-001</org_study_id>
    <nct_id>NCT03283241</nct_id>
  </id_info>
  <brief_title>Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism</brief_title>
  <official_title>A Randomized, Multicentre, Double Blind, Parallel Study to Evaluate the Performance and Safety of the Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Addbio AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Addbio AB</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>
      A randomised, multicentre, double blind, parallel group comparative investigation where&#xD;
      subjects will be randomised to receive coated or uncoated implants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of two parts. Part I, is the main study ending when all subjects have&#xD;
      reached visit 5. The study will be evaluated and Clinical Study Report (CSR) will be written&#xD;
      for this part.&#xD;
&#xD;
      Part II, of the study is a post-follow up study starting when the first subject has completed&#xD;
      visit 5. There will be a separate CSR written for Study Part II.&#xD;
&#xD;
      The study Part I will begin with a baseline visit, visit 1, Informed consent procedure will&#xD;
      take place. Provided the subject will give informed consent for both Study Part I and Study&#xD;
      Part II the screening procedure starts. Subjects will undergo all screening and baseline&#xD;
      assessment procedures including assessments of dental status to determine number of implants&#xD;
      needed. Subjects who meet all the inclusion criteria and none of the exclusion criteria will&#xD;
      be given a date for implant surgery within three weeks. The required number of implants will&#xD;
      be ordered from the Study Distributor.&#xD;
&#xD;
      At the implantation day, visit 2, eligibility will be re-checked before the surgery&#xD;
      procedures starts. The subjects who still are eligible will enter the treatment and the&#xD;
      implantation surgery is conducted. The first follow-up visit after implantation will take&#xD;
      place week 2 post-surgery and the last follow-up visit in Study Part I will be at week 12.&#xD;
      Any post-surgical complications and adverse events will be collected and recorded in the&#xD;
      eCRF. On demand, depending on the outcome of the surgery, additional visits might occur.&#xD;
&#xD;
      Study Part II, the Post Follow-up Study, consist of two visits, one at month 12 and another&#xD;
      visit at month 24 post-surgery. Post-surgical complications and adverse events from Study&#xD;
      Part I will be followed-up if not resolved previously. Safety, survival rate and marginal&#xD;
      bone loss will be assessed and outcome recorded in the eCRF. Additional visits might occur&#xD;
      depending on the status of the subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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>
    <intervention_model_description>Parallel groups ration 1;1</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The devices are delivered single packed and sterile to distributor. The distributor performs blinding, randomization and distribution. The labels are, after blinding of lot number, identical for both the Active and the placebo device.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the &quot;Index Implant&quot; Comparing Coated and Uncoated Implants</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the &quot;index implant&quot; between coated and uncoated implants.&#xD;
An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100&#xD;
1 No stability 100 stability The aim is to get as close to a 100 as possible</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the &quot;Index Implant&quot; at Week 8 and Week 12</measure>
    <time_frame>week 8 and week 12</time_frame>
    <description>To compare absolute ISQ (Implant Stability Quotient) highest values between coated and uncoated &quot;index implants&quot; at week 8 and week 12 after implantation An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability Aim its to get close to 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Post-surgery Complications and Adverse Events</measure>
    <time_frame>Day1 to week 12</time_frame>
    <description>To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ISQ (Implant Stability Quotient) Highest Value for the &quot;Index Implant&quot;</measure>
    <time_frame>Day 1 to week 8</time_frame>
    <description>To compare change in stability from day 1 to week 8 between the coated and the uncoated &quot;index implants&quot; An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100&#xD;
1 No stability 100 stability The aim is to get as close to a 100 as possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ISQ Highest Value for All Other Implants</measure>
    <time_frame>week 8 and week 12</time_frame>
    <description>To compare change in stability from day 1 to week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants</measure>
    <time_frame>Week 8 and 12</time_frame>
    <description>To compare absolute ISQ (Implant Stability Quotient) highest value at week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Marginal Bone Height for All Other Implants</measure>
    <time_frame>week 8 and 12</time_frame>
    <description>To compare change in marginal bone height between all coated and all uncoated implants from at week 8 and 12 The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-surgical Complications and Other Adverse Events (AEs) for All Implants</measure>
    <time_frame>month 24</time_frame>
    <description>To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival Rate for All Implants</measure>
    <time_frame>24 months</time_frame>
    <description>To compare survival rate of implants up to 24 months between all coated and all uncoated implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Marginal Bone Height for All Implants</measure>
    <time_frame>Day 1, month 12 and 24</time_frame>
    <description>To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Signs Associated With Peri-implantitis for All Implants</measure>
    <time_frame>Month 12 and 24</time_frame>
    <description>To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants Ocular assessment of redness and swelling this is an overall judgement of peri-implantitis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Partial Edentulism</condition>
  <arm_group>
    <arm_group_label>Zolidd One ExHex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Coated titanium implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One ExHex</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Uncoated titanium implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zolidd One ExHex</intervention_name>
    <description>Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
    <arm_group_label>One ExHex</arm_group_label>
    <arm_group_label>Zolidd One ExHex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>One ExHex</intervention_name>
    <description>Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
    <arm_group_label>One ExHex</arm_group_label>
    <arm_group_label>Zolidd One ExHex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged &gt;18 years&#xD;
&#xD;
          -  Subjects should be willing to take part, able to understand the information given to&#xD;
             them, and give written consent&#xD;
&#xD;
          -  Subject diagnosed with partial edentulism and who needs at least one dental implant in&#xD;
             the posterior upper jaw i.e. premolars to first molar. The same subject may also need&#xD;
             implants in the posterior mandible (premolars to first molar region)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected to be immunocompromised or are taking immunosuppressant&#xD;
&#xD;
          -  Current participation in another clinical investigation or participation within the&#xD;
             last 6 months&#xD;
&#xD;
          -  Known sensitivity/allergies to any of the test materials or any of their ingredients,&#xD;
             such as bisphosphonate, titanium or human fibrinogen&#xD;
&#xD;
          -  Significant current or past medical history of hepatic, renal, cardiac, pulmonary,&#xD;
             digestive, haematological, neurological, or psychiatric disease, hypercalcaemia,&#xD;
             previous or ongoing malignancy in the head and neck region or uncontrolled diabetes&#xD;
             type I which in the opinion of the Investigator, would compromise the safety of the&#xD;
             subject or affect the outcome of the investigation&#xD;
&#xD;
          -  Pregnant and lactating females or those actively seeking to become pregnant in the&#xD;
             next 3 months&#xD;
&#xD;
          -  Previous (last 5 years) or on-going Bisphosphonate or Denosumab treatment&#xD;
&#xD;
          -  Significant marginal bone loss prior to implant insertion requiring bone grafting or&#xD;
             bone graft substitute&#xD;
&#xD;
          -  Subject with extraction(s) performed in the position of implant placement within the&#xD;
             last 2 months&#xD;
&#xD;
          -  Subject with need of &gt;6 implants or a full bridge&#xD;
&#xD;
          -  The final prosthetic construction in need of support from neighbouring teeth&#xD;
&#xD;
          -  Known drug or alcohol abuse&#xD;
&#xD;
          -  Subjects only needed implant(s) in the posterior mandible region&#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>Christer Dahlin, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Käk kirurgiska kliniken NÄL, Trollhättan, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dingletandläkarna</name>
      <address>
        <city>Dingle</city>
        <zip>45561</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praktikertjänst AB Holmgatans Tandläkarmottagning</name>
      <address>
        <city>Falun</city>
        <zip>79171</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Käk-kirurgiska Kliniken, Näl</name>
      <address>
        <city>Trollhättan</city>
        <zip>46185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>November 8, 2021</results_first_submitted>
  <results_first_submitted_qc>January 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2022</results_first_posted>
  <last_update_submitted>January 21, 2022</last_update_submitted>
  <last_update_submitted_qc>January 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not planned at the moment</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03283241/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03283241/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Sixty two patient started the study</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Zolidd One ExHex</title>
          <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
        </group>
        <group group_id="P2">
          <title>One ExHex</title>
          <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 12 Weeks</title>
              <participants_list>
                <participants group_id="P1" count="29">Completed 12 weeks</participants>
                <participants group_id="P2" count="29">Completed 12 weeks</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28">Completed 24 month</participants>
                <participants group_id="P2" count="27">Completed 24 month</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject relocated to Finland</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT population Zolidd One exHex 32 One ExHex 30</population>
      <group_list>
        <group group_id="B1">
          <title>Zolidd One ExHex</title>
          <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
        </group>
        <group group_id="B2">
          <title>One ExHex</title>
          <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.4" spread="14.0"/>
                    <measurement group_id="B2" value="60.7" spread="12.4"/>
                    <measurement group_id="B3" value="58.5" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the &quot;Index Implant&quot; Comparing Coated and Uncoated Implants</title>
        <description>The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the &quot;index implant&quot; between coated and uncoated implants.&#xD;
An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100&#xD;
1 No stability 100 stability The aim is to get as close to a 100 as possible</description>
        <time_frame>12 weeks</time_frame>
        <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the &quot;Index Implant&quot; Comparing Coated and Uncoated Implants</title>
          <description>The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the &quot;index implant&quot; between coated and uncoated implants.&#xD;
An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100&#xD;
1 No stability 100 stability The aim is to get as close to a 100 as possible</description>
          <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
          <units>ISQ (Implant Stability Quotient) score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.47" spread="25.71"/>
                    <measurement group_id="O2" value="2.83" spread="16.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the &quot;Index Implant&quot; at Week 8 and Week 12</title>
        <description>To compare absolute ISQ (Implant Stability Quotient) highest values between coated and uncoated &quot;index implants&quot; at week 8 and week 12 after implantation An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability Aim its to get close to 100</description>
        <time_frame>week 8 and week 12</time_frame>
        <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the &quot;Index Implant&quot; at Week 8 and Week 12</title>
          <description>To compare absolute ISQ (Implant Stability Quotient) highest values between coated and uncoated &quot;index implants&quot; at week 8 and week 12 after implantation An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability Aim its to get close to 100</description>
          <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
          <units>ISQ Score</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Post-surgery Complications and Adverse Events</title>
        <description>To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants</description>
        <time_frame>Day1 to week 12</time_frame>
        <population>This is the Adverse Event (AE) that has been reported and will be presented in the AE table under product issues, this is devices that failed and/or lossened At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Post-surgery Complications and Adverse Events</title>
          <description>To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants</description>
          <population>This is the Adverse Event (AE) that has been reported and will be presented in the AE table under product issues, this is devices that failed and/or lossened At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
          <units>Number of events reported</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ISQ (Implant Stability Quotient) Highest Value for the &quot;Index Implant&quot;</title>
        <description>To compare change in stability from day 1 to week 8 between the coated and the uncoated &quot;index implants&quot; An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100&#xD;
1 No stability 100 stability The aim is to get as close to a 100 as possible</description>
        <time_frame>Day 1 to week 8</time_frame>
        <population>In the Zolidd One ExHex 3 subjects have missing information. In the One ExHex group 1 subject have missing information at week 8 and 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ISQ (Implant Stability Quotient) Highest Value for the &quot;Index Implant&quot;</title>
          <description>To compare change in stability from day 1 to week 8 between the coated and the uncoated &quot;index implants&quot; An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100&#xD;
1 No stability 100 stability The aim is to get as close to a 100 as possible</description>
          <population>In the Zolidd One ExHex 3 subjects have missing information. In the One ExHex group 1 subject have missing information at week 8 and 12.</population>
          <units>ISQ Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.34" spread="10.83"/>
                    <measurement group_id="O2" value="1.38" spread="8.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ISQ Highest Value for All Other Implants</title>
        <description>To compare change in stability from day 1 to week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability</description>
        <time_frame>week 8 and week 12</time_frame>
        <population>At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ISQ Highest Value for All Other Implants</title>
          <description>To compare change in stability from day 1 to week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability</description>
          <population>At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
          <units>ISQ Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Implants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Implants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="21.6"/>
                    <measurement group_id="O2" value="5.1" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Implants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="22.2"/>
                    <measurement group_id="O2" value="3.7" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants</title>
        <description>To compare absolute ISQ (Implant Stability Quotient) highest value at week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability</description>
        <time_frame>Week 8 and 12</time_frame>
        <population>At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants</title>
          <description>To compare absolute ISQ (Implant Stability Quotient) highest value at week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100&#xD;
1 No stability 100 stability</description>
          <population>At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
          <units>ISQ Score</units>
          <param>Number</param>
          <units_analyzed>Implants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Implants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Implants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Marginal Bone Height for All Other Implants</title>
        <description>To compare change in marginal bone height between all coated and all uncoated implants from at week 8 and 12 The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)</description>
        <time_frame>week 8 and 12</time_frame>
        <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Marginal Bone Height for All Other Implants</title>
          <description>To compare change in marginal bone height between all coated and all uncoated implants from at week 8 and 12 The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)</description>
          <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex</population>
          <units>mm(milimeter)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8 Mesial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.7"/>
                    <measurement group_id="O2" value="0.2" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 Distal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.8"/>
                    <measurement group_id="O2" value="0.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Mesial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.5"/>
                    <measurement group_id="O2" value="0.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Distal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.0"/>
                    <measurement group_id="O2" value="0.4" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-surgical Complications and Other Adverse Events (AEs) for All Implants</title>
        <description>To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants</description>
        <time_frame>month 24</time_frame>
        <population>See adverse events, all implant loss is reported as adverse events</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-surgical Complications and Other Adverse Events (AEs) for All Implants</title>
          <description>To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants</description>
          <population>See adverse events, all implant loss is reported as adverse events</population>
          <units>Number of events reported</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Survival Rate for All Implants</title>
        <description>To compare survival rate of implants up to 24 months between all coated and all uncoated implants</description>
        <time_frame>24 months</time_frame>
        <population>At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Survival Rate for All Implants</title>
          <description>To compare survival rate of implants up to 24 months between all coated and all uncoated implants</description>
          <population>At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)</population>
          <units>Number of implant loss</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Implants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.930" lower_limit="0.824" upper_limit="0.973"/>
                    <measurement group_id="O2" value="0.939" lower_limit="0.822" upper_limit="0.980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Marginal Bone Height for All Implants</title>
        <description>To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)</description>
        <time_frame>Day 1, month 12 and 24</time_frame>
        <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex (29 subjects) and 1 subject have missing data in One ExHex (29 subjects) At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Marginal Bone Height for All Implants</title>
          <description>To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)</description>
          <population>At 12 weeks 3 subjects have missing data in Zolidd One ExHex (29 subjects) and 1 subject have missing data in One ExHex (29 subjects) At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)</population>
          <units>mm(millimeter)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 Mesial</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.8"/>
                    <measurement group_id="O2" value="0.3" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Distal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.9"/>
                    <measurement group_id="O2" value="0.3" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24 Mesial</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.0"/>
                    <measurement group_id="O2" value="0.5" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24 Distal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.0"/>
                    <measurement group_id="O2" value="0.5" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Signs Associated With Peri-implantitis for All Implants</title>
        <description>To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants Ocular assessment of redness and swelling this is an overall judgement of peri-implantitis</description>
        <time_frame>Month 12 and 24</time_frame>
        <population>At 12 and 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)</population>
        <group_list>
          <group group_id="O1">
            <title>Zolidd One ExHex</title>
            <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
          <group group_id="O2">
            <title>One ExHex</title>
            <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Signs Associated With Peri-implantitis for All Implants</title>
          <description>To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants Ocular assessment of redness and swelling this is an overall judgement of peri-implantitis</description>
          <population>At 12 and 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects)</population>
          <units>number of participants redness/swollen</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse events were collected from visit 1 to 24 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Zolidd One ExHex</title>
          <description>Coated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
        </group>
        <group group_id="E2">
          <title>One ExHex</title>
          <description>Uncoated titanium implant&#xD;
Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.&#xD;
One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the &quot;index implant&quot;and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Stress fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pan</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device Failure</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ulf Sewerin, CEO</name_or_title>
      <organization>AddBio AB</organization>
      <phone>+46708797988</phone>
      <email>ulf.sewerin@addbio.se</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03283241
org study id: ADD-001
nct id: NCT03283241
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomised, multicentre, double blind, parallel group comparative investigation where
      subjects will be randomised to receive coated or uncoated implants
The study will consist of two parts. Part I, is the main study ending when all subjects have
      reached visit 5. The study will be evaluated and Clinical Study Report (CSR) will be written
      for this part.

      Part II, of the study is a post-follow up study starting when the first subject has completed
      visit 5. There will be a separate CSR written for Study Part II.

      The study Part I will begin with a baseline visit, visit 1, Informed consent procedure will
      take place. Provided the subject will give informed consent for both Study Part I and Study
      Part II the screening procedure starts. Subjects will undergo all screening and baseline
      assessment procedures including assessments of dental status to determine number of implants
      needed. Subjects who meet all the inclusion criteria and none of the exclusion criteria will
      be given a date for implant surgery within three weeks. The required number of implants will
      be ordered from the Study Distributor.

      At the implantation day, visit 2, eligibility will be re-checked before the surgery
      procedures starts. The subjects who still are eligible will enter the treatment and the
      implantation surgery is conducted. The first follow-up visit after implantation will take
      place week 2 post-surgery and the last follow-up visit in Study Part I will be at week 12.
      Any post-surgical complications and adverse events will be collected and recorded in the
      eCRF. On demand, depending on the outcome of the surgery, additional visits might occur.

      Study Part II, the Post Follow-up Study, consist of two visits, one at month 12 and another
      visit at month 24 post-surgery. Post-surgical complications and adverse events from Study
      Part I will be followed-up if not resolved previously. Safety, survival rate and marginal
      bone loss will be assessed and outcome recorded in the eCRF. Additional visits might occur
      depending on the status of the subjects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel groups ration 1;1
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: The devices are delivered single packed and sterile to distributor. The distributor performs blinding, randomization and distribution. The labels are, after blinding of lot number, identical for both the Active and the placebo device.
measure: Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the "Index Implant" Comparing Coated and Uncoated Implants
time frame: 12 weeks
description: The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the "index implant" between coated and uncoated implants.
An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100
1 No stability 100 stability The aim is to get as close to a 100 as possible
measure: To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12
time frame: week 8 and week 12
description: To compare absolute ISQ (Implant Stability Quotient) highest values between coated and uncoated "index implants" at week 8 and week 12 after implantation An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100
1 No stability 100 stability Aim its to get close to 100
measure: Incidence of Post-surgery Complications and Adverse Events
time frame: Day1 to week 12
description: To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants
measure: Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant"
time frame: Day 1 to week 8
description: To compare change in stability from day 1 to week 8 between the coated and the uncoated "index implants" An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100
1 No stability 100 stability The aim is to get as close to a 100 as possible
measure: Change in ISQ Highest Value for All Other Implants
time frame: week 8 and week 12
description: To compare change in stability from day 1 to week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100
1 No stability 100 stability
measure: Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants
time frame: Week 8 and 12
description: To compare absolute ISQ (Implant Stability Quotient) highest value at week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100
1 No stability 100 stability
measure: Change in Marginal Bone Height for All Other Implants
time frame: week 8 and 12
description: To compare change in marginal bone height between all coated and all uncoated implants from at week 8 and 12 The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)
measure: Post-surgical Complications and Other Adverse Events (AEs) for All Implants
time frame: month 24
description: To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants
measure: Survival Rate for All Implants
time frame: 24 months
description: To compare survival rate of implants up to 24 months between all coated and all uncoated implants
measure: Change in Marginal Bone Height for All Implants
time frame: Day 1, month 12 and 24
description: To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter)
measure: Occurrence of Signs Associated With Peri-implantitis for All Implants
time frame: Month 12 and 24
description: To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants Ocular assessment of redness and swelling this is an overall judgement of peri-implantitis
arm group label: Zolidd One ExHex
arm group type: Active Comparator
description: Coated titanium implant
arm group label: One ExHex
arm group type: Sham Comparator
description: Uncoated titanium implant
intervention type: Device
intervention name: Zolidd One ExHex
description: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
arm group label: One ExHex
arm group label: Zolidd One ExHex
intervention type: Device
intervention name: One ExHex
description: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.
arm group label: One ExHex
arm group label: Zolidd One ExHex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christer Dahlin, DDS, PhD
role: Principal Investigator
affiliation: Käk kirurgiska kliniken NÄL, Trollhättan, Sweden
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country: Sweden
responsible party type: Sponsor
sharing ipd: No
ipd description: Not planned at the moment
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