<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/NCT03041597</url>
  </required_header>
  <id_info>
    <org_study_id>B32220096198</org_study_id>
    <nct_id>NCT03041597</nct_id>
  </id_info>
  <brief_title>Dental Implant Supported Removable Dental Prostheses</brief_title>
  <official_title>An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dentsply Sirona Implants and Consumables</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed&#xD;
      versus immediate loading, using abutments with the SynCone® concept for implant-supported&#xD;
      detachable dental prosthesis (ISDDP) in the edentulous upper jaw.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2009</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bone loss</measure>
    <time_frame>Difference between loading and Year two</time_frame>
    <description>measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>probing pocket depth</measure>
    <time_frame>Difference between loading and Year two</time_frame>
    <description>Measurement in mm, 4 sites per implant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plaque</measure>
    <time_frame>Difference between loading and Year two</time_frame>
    <description>presence of plaque, 4 sites per implant, Yes=1 or No=0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bleeding on probing</measure>
    <time_frame>Difference between loading and Year two</time_frame>
    <description>presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Implant Complication</condition>
  <condition>Prosthesis Survival</condition>
  <arm_group>
    <arm_group_label>Immediate loading</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>delayed loading</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>placement of implants</intervention_name>
    <description>surgical procedure and placement of implants</description>
    <arm_group_label>Immediate loading</arm_group_label>
    <arm_group_label>delayed loading</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>immediate loading</intervention_name>
    <description>cone-anchored implant supported removable dental prostheses placement</description>
    <arm_group_label>Immediate loading</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional loading</intervention_name>
    <description>cone-anchored implant supported removable dental prostheses placement in 3mo</description>
    <arm_group_label>delayed loading</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ankylos implant</intervention_name>
    <arm_group_label>Immediate loading</arm_group_label>
    <arm_group_label>delayed loading</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
          -  Extraction sockets should have healed at least 4 months&#xD;
&#xD;
          -  Sufficient bone volume to place six implants in the maxilla&#xD;
&#xD;
          -  No previous bone augmentation procedures&#xD;
&#xD;
          -  The mandible can have any kind of dentition as long as a well-distributed contact&#xD;
             relationship with the new prosthesis in the maxilla can be established.&#xD;
&#xD;
          -  Accepting to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical or psychological disorders prohibiting implant treatment&#xD;
&#xD;
          -  Heavy smoking (&gt;10 cigarettes/day)&#xD;
&#xD;
          -  Present alcohol and/or drug abuse&#xD;
&#xD;
          -  Physical handicap that may interfere with the ability to perform oral hygiene&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Lauren Bernard</investigator_full_name>
    <investigator_title>Periodontist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prosthesis Failure</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/NCT03041597
org study id: B32220096198
nct id: NCT03041597
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed
      versus immediate loading, using abutments with the SynCone® concept for implant-supported
      detachable dental prosthesis (ISDDP) in the edentulous upper jaw.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: bone loss
time frame: Difference between loading and Year two
description: measured in mm op peri-apical radiography. Mesial and Distal measurement of implant.
measure: probing pocket depth
time frame: Difference between loading and Year two
description: Measurement in mm, 4 sites per implant.
measure: plaque
time frame: Difference between loading and Year two
description: presence of plaque, 4 sites per implant, Yes=1 or No=0
measure: bleeding on probing
time frame: Difference between loading and Year two
description: presence of bleeding on probing, 4 sites per implant, Yes=1 or No=0
arm group label: Immediate loading
arm group type: Experimental
arm group label: delayed loading
arm group type: Active Comparator
intervention type: Procedure
intervention name: placement of implants
description: surgical procedure and placement of implants
arm group label: Immediate loading
arm group label: delayed loading
intervention type: Procedure
intervention name: immediate loading
description: cone-anchored implant supported removable dental prostheses placement
arm group label: Immediate loading
intervention type: Procedure
intervention name: conventional loading
description: cone-anchored implant supported removable dental prostheses placement in 3mo
arm group label: delayed loading
intervention type: Device
intervention name: Ankylos implant
arm group label: Immediate loading
arm group label: delayed loading
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Lauren Bernard
investigator title: Periodontist
mesh term: Prosthesis Failure
sharing ipd: Undecided