<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/NCT03041584</url>
  </required_header>
  <id_info>
    <org_study_id>B32220095376</org_study_id>
    <nct_id>NCT03041584</nct_id>
  </id_info>
  <brief_title>Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study</brief_title>
  <official_title>Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess implant outcomes, both clinical and radiological, in a randomized study on guided&#xD;
      implant placement after 3-year follow-up, compared to non-guided treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2009</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic outcome</measure>
    <time_frame>Change between baseline and 3 Year</time_frame>
    <description>Bone loss in mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>probing pocket depth</measure>
    <time_frame>Change between baseline and 3 Year</time_frame>
    <description>measurement in mm of pocket around implant, 4 per implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bleeding on probing</measure>
    <time_frame>Change between baseline and 3 Year</time_frame>
    <description>measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plaque</measure>
    <time_frame>Change between baseline and 3 Year</time_frame>
    <description>measurement of presence of plaque, Yes =1, No=0. 4 per implant</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Dental Implant Failure Nos</condition>
  <arm_group>
    <arm_group_label>Materialise Universal®/ mucosa (Mat Mu)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Materialise Universal®/ bone (Mat Bo)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FacilitateTM/ mucosa (Fac Mu)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FacilitateTM/ bone (Fac Bo)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>mental navigation (Mental)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>pilot-drill template (Templ)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Guided placement</intervention_name>
    <description>implant placement with use of guide</description>
    <arm_group_label>FacilitateTM/ bone (Fac Bo)</arm_group_label>
    <arm_group_label>FacilitateTM/ mucosa (Fac Mu)</arm_group_label>
    <arm_group_label>Materialise Universal®/ bone (Mat Bo)</arm_group_label>
    <arm_group_label>Materialise Universal®/ mucosa (Mat Mu)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-guided placement</intervention_name>
    <description>conventional implant placement</description>
    <arm_group_label>mental navigation (Mental)</arm_group_label>
    <arm_group_label>pilot-drill template (Templ)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Astra Tech TX implant</intervention_name>
    <arm_group_label>FacilitateTM/ bone (Fac Bo)</arm_group_label>
    <arm_group_label>FacilitateTM/ mucosa (Fac Mu)</arm_group_label>
    <arm_group_label>Materialise Universal®/ bone (Mat Bo)</arm_group_label>
    <arm_group_label>Materialise Universal®/ mucosa (Mat Mu)</arm_group_label>
    <arm_group_label>mental navigation (Mental)</arm_group_label>
    <arm_group_label>pilot-drill template (Templ)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent&#xD;
&#xD;
          2. An age of at least 18 year&#xD;
&#xD;
          3. Extraction socket healing for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unlikely to be able to comply with study procedures&#xD;
&#xD;
          2. History of intravenous bisphosphonate treatment&#xD;
&#xD;
          3. Medical history that makes implant insertion unfavorable&#xD;
&#xD;
          4. Current pregnancy&#xD;
&#xD;
          5. Present alcohol and/or drug abuse&#xD;
&#xD;
          6. Major systemic diseases&#xD;
&#xD;
          7. Untreated, uncontrolled caries and/or periodontal disease&#xD;
&#xD;
          8. History of local irradiation&#xD;
&#xD;
          9. Need for bone grafting and/or sinus lift in the planned implant area&#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>
  <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/NCT03041584
org study id: B32220095376
nct id: NCT03041584
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess implant outcomes, both clinical and radiological, in a randomized study on guided
      implant placement after 3-year follow-up, compared to non-guided treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Radiographic outcome
time frame: Change between baseline and 3 Year
description: Bone loss in mm
measure: probing pocket depth
time frame: Change between baseline and 3 Year
description: measurement in mm of pocket around implant, 4 per implant
measure: bleeding on probing
time frame: Change between baseline and 3 Year
description: measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant
measure: plaque
time frame: Change between baseline and 3 Year
description: measurement of presence of plaque, Yes =1, No=0. 4 per implant
arm group label: Materialise Universal®/ mucosa (Mat Mu)
arm group type: Experimental
arm group label: Materialise Universal®/ bone (Mat Bo)
arm group type: Experimental
arm group label: FacilitateTM/ mucosa (Fac Mu)
arm group type: Experimental
arm group label: FacilitateTM/ bone (Fac Bo)
arm group type: Experimental
arm group label: mental navigation (Mental)
arm group type: Active Comparator
arm group label: pilot-drill template (Templ)
arm group type: Active Comparator
intervention type: Procedure
intervention name: Guided placement
description: implant placement with use of guide
arm group label: FacilitateTM/ bone (Fac Bo)
arm group label: FacilitateTM/ mucosa (Fac Mu)
arm group label: Materialise Universal®/ bone (Mat Bo)
arm group label: Materialise Universal®/ mucosa (Mat Mu)
intervention type: Procedure
intervention name: Non-guided placement
description: conventional implant placement
arm group label: mental navigation (Mental)
arm group label: pilot-drill template (Templ)
intervention type: Device
intervention name: Astra Tech TX implant
arm group label: FacilitateTM/ bone (Fac Bo)
arm group label: FacilitateTM/ mucosa (Fac Mu)
arm group label: Materialise Universal®/ bone (Mat Bo)
arm group label: Materialise Universal®/ mucosa (Mat Mu)
arm group label: mental navigation (Mental)
arm group label: pilot-drill template (Templ)
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
sharing ipd: Undecided