<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/NCT04499625</url>
  </required_header>
  <id_info>
    <org_study_id>B707201316423</org_study_id>
    <nct_id>NCT04499625</nct_id>
  </id_info>
  <brief_title>Lateral Window Versus Intralift™ Sinus Floor Elevation</brief_title>
  <official_title>Intraoperative and Postoperative Outcomes of Sinus Floor Elevation Using Lateral Window Technique Versus Hydrodynamic Transalveolar Approach: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several approaches have been used in order to regenerate bone in the upper jaw in case of&#xD;
      insufficient alveolar bone height for implant placement. However, new emerging techniques&#xD;
      need to be assessed and compared to conventional methods in order to define their potential&#xD;
      indications.&#xD;
&#xD;
      The purpose of the present randomized controlled clinical trial was to compare the clinical&#xD;
      outcomes of two sinus floor elevation techniques: conventional lateral window technique&#xD;
      versus a novel transalveolar approach using hydrodynamic ultrasonic device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2013</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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 (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sinus membrane perforation</measure>
    <time_frame>During the surgery (from beginning to end)</time_frame>
    <description>Presence/absence of sinus membrane perforation during the surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical procedure duration</measure>
    <time_frame>From beginning of surgery until the end of surgery</time_frame>
    <description>The time measurement started from the administration of local anesthesia and ended when the placement of final suture was completed. The time was measured using a stopwatch.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Edema</measure>
    <time_frame>From the end of surgery up to 1 week postoperatively</time_frame>
    <description>Presence/absence of edema postoperatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hematoma</measure>
    <time_frame>From the end of surgery up to 1 week postoperatively</time_frame>
    <description>Presence/absence of hematoma postoperatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postsurgical bleeding</measure>
    <time_frame>From the end of surgery up to 1 week postoperatively</time_frame>
    <description>Presence/absence of bleeding postoperatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nasal discharge</measure>
    <time_frame>From the end of surgery up to 1 week postoperatively</time_frame>
    <description>Presence/absence of nasal discharge postoperatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NSAID consumption</measure>
    <time_frame>From the end of surgery up to 1 week postoperatively</time_frame>
    <description>Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient related outcome measures (PROMs)</measure>
    <time_frame>From right before the surgery up to 1 week postoperatively</time_frame>
    <description>PROMs were assessed with a questionnaire using a visual analogue scale (VAS), which was given to all participants in order to assess their perception before, during, and after the intervention. A graduated scale from 0 to 10 was used, with a lower score presenting a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic outcomes</measure>
    <time_frame>From the baseline (surgery procedure) up to 1 year post-surgery</time_frame>
    <description>Radiographic (CBCT) qualitative assessment of the gained volume (change in volume from baseline to 1 year postoperatively).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant survival rates</measure>
    <time_frame>From the baseline (surgery procedure) up to 1 year post-surgery</time_frame>
    <description>Implant survival rates assessment at 1 year postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Intraoperative Outcomes</condition>
  <condition>Postoperative Outcomes</condition>
  <arm_group>
    <arm_group_label>Control - Lateral window</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard surgical technique to access maxillary sinus for sinus floor augmentation procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test - Hydrodynamic transalveolar approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Novel transalveolar approach (using an ultrasonic device) to access maxillary sinus for sinus floor augmentation procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sinus floor elevation</intervention_name>
    <arm_group_label>Control - Lateral window</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sinus floor elevation using an ultrasonic device</intervention_name>
    <arm_group_label>Test - Hydrodynamic transalveolar approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  edentulism in the posterior maxilla (unitary or plural)&#xD;
&#xD;
          -  need of a sinus floor augmentation procedure before implant placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any uncontrolled systemic disease&#xD;
&#xD;
          -  ongoing chemo- or radiotherapy&#xD;
&#xD;
          -  history of maxillary sinus diseases or acute sinus-related issues&#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>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Dr. France LAMBERT</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04499625
org study id: B707201316423
nct id: NCT04499625
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Several approaches have been used in order to regenerate bone in the upper jaw in case of
      insufficient alveolar bone height for implant placement. However, new emerging techniques
      need to be assessed and compared to conventional methods in order to define their potential
      indications.

      The purpose of the present randomized controlled clinical trial was to compare the clinical
      outcomes of two sinus floor elevation techniques: conventional lateral window technique
      versus a novel transalveolar approach using hydrodynamic ultrasonic device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Sinus membrane perforation
time frame: During the surgery (from beginning to end)
description: Presence/absence of sinus membrane perforation during the surgery
measure: Surgical procedure duration
time frame: From beginning of surgery until the end of surgery
description: The time measurement started from the administration of local anesthesia and ended when the placement of final suture was completed. The time was measured using a stopwatch.
measure: Edema
time frame: From the end of surgery up to 1 week postoperatively
description: Presence/absence of edema postoperatively
measure: Hematoma
time frame: From the end of surgery up to 1 week postoperatively
description: Presence/absence of hematoma postoperatively
measure: Postsurgical bleeding
time frame: From the end of surgery up to 1 week postoperatively
description: Presence/absence of bleeding postoperatively
measure: Nasal discharge
time frame: From the end of surgery up to 1 week postoperatively
description: Presence/absence of nasal discharge postoperatively
measure: NSAID consumption
time frame: From the end of surgery up to 1 week postoperatively
description: Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)
measure: Patient related outcome measures (PROMs)
time frame: From right before the surgery up to 1 week postoperatively
description: PROMs were assessed with a questionnaire using a visual analogue scale (VAS), which was given to all participants in order to assess their perception before, during, and after the intervention. A graduated scale from 0 to 10 was used, with a lower score presenting a better outcome.
measure: Radiographic outcomes
time frame: From the baseline (surgery procedure) up to 1 year post-surgery
description: Radiographic (CBCT) qualitative assessment of the gained volume (change in volume from baseline to 1 year postoperatively).
measure: Implant survival rates
time frame: From the baseline (surgery procedure) up to 1 year post-surgery
description: Implant survival rates assessment at 1 year postoperatively.
arm group label: Control - Lateral window
arm group type: Other
description: Standard surgical technique to access maxillary sinus for sinus floor augmentation procedure.
arm group label: Test - Hydrodynamic transalveolar approach
arm group type: Experimental
description: Novel transalveolar approach (using an ultrasonic device) to access maxillary sinus for sinus floor augmentation procedure.
intervention type: Procedure
intervention name: Sinus floor elevation
arm group label: Control - Lateral window
intervention type: Device
intervention name: Sinus floor elevation using an ultrasonic device
arm group label: Test - Hydrodynamic transalveolar approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Dr. France LAMBERT
investigator title: Professor