<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/NCT03776097</url>
  </required_header>
  <id_info>
    <org_study_id>23530231</org_study_id>
    <nct_id>NCT03776097</nct_id>
  </id_info>
  <brief_title>Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study</brief_title>
  <official_title>Non-interventional Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Follow-up (PMCF) Study 13.530.231</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geistlich Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Geistlich Pharma AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this non-interventional long-term follow-up observation is to evaluate the&#xD;
      long-term sustainability of two surgical treatments of peri-implantitis with and without&#xD;
      Geistlich Bio-Oss® and Geistlich Bio-Gide® from a previous study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a non-interventional long-term follow-up observation without any study specific&#xD;
      procedure outside normal clinical routine. Patients from a previous study are selected to&#xD;
      participate in this study within a standard maintenance Programm. Primary and secondary&#xD;
      oucomes refer to the previous study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">March 21, 2019</completion_date>
  <primary_completion_date type="Actual">March 21, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Defect fill</measure>
    <time_frame>2 years after the start of the study</time_frame>
    <description>The primary outcome measure will be the change of &quot;bone levels&quot;(defect fill) over 2 years starting 1 year after surgical Intervention as assessed from intra-oral radiographs. In particular, the distances between the most apical implant to bone contact level and a characteristic reference point being the same for all sets of radiographs will be measured. The distance equal to three implant threads (known for the implant system) will be measured with a specific Software. The deeper bone level at baseline will be considered</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Peri-implantitis</condition>
  <arm_group>
    <arm_group_label>Defect Fill.</arm_group_label>
    <description>Observational study of the patients that were treated with biomaterials at the surgery in the previous study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No defect Fill.observational</arm_group_label>
    <description>Observational study of the patients that were not treated with biomaterials at the surgery of te previous study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational study</intervention_name>
    <description>Observational study</description>
    <arm_group_label>Defect Fill.</arm_group_label>
    <arm_group_label>No defect Fill.observational</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients from a previous study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implant survival at the treated site from the previous study&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Implant failure at the treated site&#xD;
&#xD;
          -  Severe trauma to implant site causing removal of the implant since the last visit of&#xD;
             previous study&#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>Silvia Rasi, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Geistlich Pharma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefan Renvert</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kristianstadt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kristianstad University</name>
      <address>
        <city>Kristianstad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>August 23, 2019</last_update_submitted>
  <last_update_submitted_qc>August 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peri-Implantitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03776097
org study id: 23530231
nct id: NCT03776097
lead sponsor: 
has dmc: No
The objective of this non-interventional long-term follow-up observation is to evaluate the
      long-term sustainability of two surgical treatments of peri-implantitis with and without
      Geistlich Bio-Oss® and Geistlich Bio-Gide® from a previous study
The study is a non-interventional long-term follow-up observation without any study specific
      procedure outside normal clinical routine. Patients from a previous study are selected to
      participate in this study within a standard maintenance Programm. Primary and secondary
      oucomes refer to the previous study
observational model: Other
time perspective: Prospective
measure: Defect fill
time frame: 2 years after the start of the study
description: The primary outcome measure will be the change of "bone levels"(defect fill) over 2 years starting 1 year after surgical Intervention as assessed from intra-oral radiographs. In particular, the distances between the most apical implant to bone contact level and a characteristic reference point being the same for all sets of radiographs will be measured. The distance equal to three implant threads (known for the implant system) will be measured with a specific Software. The deeper bone level at baseline will be considered
arm group label: Defect Fill.
description: Observational study of the patients that were treated with biomaterials at the surgery in the previous study
arm group label: No defect Fill.observational
description: Observational study of the patients that were not treated with biomaterials at the surgery of te previous study
intervention type: Other
intervention name: observational study
description: Observational study
arm group label: Defect Fill.
arm group label: No defect Fill.observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Silvia Rasi, PhD
role: Study Director
affiliation: Geistlich Pharma
last name: Stefan Renvert
role: Principal Investigator
affiliation: Kristianstadt University
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Peri-Implantitis
sharing ipd: Undecided