<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/NCT03252106</url>
  </required_header>
  <id_info>
    <org_study_id>P004 Study</org_study_id>
    <nct_id>NCT03252106</nct_id>
  </id_info>
  <brief_title>Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement</brief_title>
  <official_title>Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective case series study, 20 patients with an implant-borne single crown&#xD;
      following early implant placement with simultaneous contour augmentation will be followed for&#xD;
      10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone&#xD;
      beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and&#xD;
      compared to the 6 year data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2016</start_date>
  <completion_date type="Actual">November 10, 2016</completion_date>
  <primary_completion_date type="Actual">November 10, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of contour augmentation</measure>
    <time_frame>10 year examination</time_frame>
    <description>Measurement of facial bone wall width with cone beam CTs (in mm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Esthetic examination</measure>
    <time_frame>10 year examination</time_frame>
    <description>Pink Esthetic Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-Implant soft tissue health</measure>
    <time_frame>10 year examination</time_frame>
    <description>Plaque Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-implant bone loss over time</measure>
    <time_frame>10 year examination</time_frame>
    <description>Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-Implant soft tissue health</measure>
    <time_frame>10 year examination</time_frame>
    <description>Sulcus Bleeding Index</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Jaw, Edentulous, Partially</condition>
  <condition>Dental Implants, Single-tooth</condition>
  <condition>Grafting Bone</condition>
  <arm_group>
    <arm_group_label>Contour augmentation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Contour augmentation with implant placement</intervention_name>
    <description>Contour augmentation with implant placement</description>
    <arm_group_label>Contour augmentation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single tooth gaps post extraction in the esthetic zone&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heavy smoking (more than 10 cigarettes per day)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Buser, DMD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</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>Jaw, Edentulous</mesh_term>
    <mesh_term>Jaw, Edentulous, Partially</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03252106
org study id: P004 Study
nct id: NCT03252106
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this prospective case series study, 20 patients with an implant-borne single crown
      following early implant placement with simultaneous contour augmentation will be followed for
      10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone
      beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and
      compared to the 6 year data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of contour augmentation
time frame: 10 year examination
description: Measurement of facial bone wall width with cone beam CTs (in mm)
measure: Esthetic examination
time frame: 10 year examination
description: Pink Esthetic Score
measure: Peri-Implant soft tissue health
time frame: 10 year examination
description: Plaque Index
measure: Peri-implant bone loss over time
time frame: 10 year examination
description: Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm
measure: Peri-Implant soft tissue health
time frame: 10 year examination
description: Sulcus Bleeding Index
arm group label: Contour augmentation
arm group type: Experimental
intervention type: Procedure
intervention name: Contour augmentation with implant placement
description: Contour augmentation with implant placement
arm group label: Contour augmentation
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Buser, DMD
role: Study Chair
affiliation: University of Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Jaw, Edentulous
mesh term: Jaw, Edentulous, Partially