<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/NCT03272100</url>
  </required_header>
  <id_info>
    <org_study_id>MSL001</org_study_id>
    <nct_id>NCT03272100</nct_id>
  </id_info>
  <brief_title>Influence of Two Different Flap Designs for Sinus Floor Elevation</brief_title>
  <official_title>Influence of Two Different Flap Designs for Sinus Floor Elevation. A Split-mouth Randomised Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Firenze and Siena, Napoli, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Firenze and Siena, Napoli, Italy</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>
      It is assumed that the reduction of the flap dimension could provide a reduction of surgical&#xD;
      time, post surgical complications and patient's discomfort when compared with the traditional&#xD;
      surgical approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      16 edentulous patients in maxillary posterior area were treated with a bilateral sinus lift&#xD;
      procedure. Once enrolled in the study impressions were realised and the radiographic stent&#xD;
      prepared, with radio-opaque references fixed in the positions where the implants should be&#xD;
      inserted. Pre-surgical CT scan was executed after placing the stent in its proper position in&#xD;
      patient's mouth. If no surgical contra-indications were detected at CT evaluation, patients&#xD;
      were involved in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2013</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>height of augmented bone obtained</measure>
    <time_frame>6 months</time_frame>
    <description>the height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of the surgery</measure>
    <time_frame>1 day</time_frame>
    <description>both total and partial times of different surgical steps were recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post surgical patient's discomfort</measure>
    <time_frame>2 weeks</time_frame>
    <description>all patients were asked to fill out a VAS scale, graduated from 1 (minimal pain ) to 10 ( maximum pain)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Bone Involvement in Diseases Classified Elsewhere</condition>
  <arm_group>
    <arm_group_label>test side ( horizontal flap)</arm_group_label>
    <description>Horizontal incision was realised in alveolar mucosa, in order to obtain the exposure of the lateral wall of the maxillary sinus, thus accessing the sinus cavity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control side ( standard flap)</arm_group_label>
    <description>Trapezoidal flap was realised, using a crestal incision and two deep vertical incisions extended in the fornix to expose the lateral wall of the maxillary sinus</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>flap</intervention_name>
    <description>after flap incision , the sinus cavity was opened and then the membrane raised up</description>
    <arm_group_label>control side ( standard flap)</arm_group_label>
    <arm_group_label>test side ( horizontal flap)</arm_group_label>
    <other_name>surgical approach</other_name>
    <other_name>Sinus augmentation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all the involved patients were edentulous in the maxillary posterior area , bilaterally,&#xD;
        with a residual bone heigh of less then 4 mm; for this reason they required a surgical bone&#xD;
        reconstruction for implant placement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient edentulous in the maxillary posterior area on both left and right side&#xD;
&#xD;
          -  residual bone height in the maxillary premolar and molar region less than 4mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of systemic diseases that would contraindicate surgical treatment&#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>
  <overall_official>
    <last_name>marco ferrari, clinical director</last_name>
    <role>Study Chair</role>
    <affiliation>tuscan school of dental medicine, university of Firenze and Siena</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siena University, Department of Periodontology, Policlinico Le Scotte Siena.</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tuscan School of Dentistry</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Firenze and Siena, Napoli, Italy</investigator_affiliation>
    <investigator_full_name>nicola baldini</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>lateral approach</keyword>
  <keyword>bone augmentation</keyword>
  <keyword>sinus lift</keyword>
  <keyword>flap</keyword>
  <!-- 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/NCT03272100
org study id: MSL001
nct id: NCT03272100
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is assumed that the reduction of the flap dimension could provide a reduction of surgical
      time, post surgical complications and patient's discomfort when compared with the traditional
      surgical approach.
16 edentulous patients in maxillary posterior area were treated with a bilateral sinus lift
      procedure. Once enrolled in the study impressions were realised and the radiographic stent
      prepared, with radio-opaque references fixed in the positions where the implants should be
      inserted. Pre-surgical CT scan was executed after placing the stent in its proper position in
      patient's mouth. If no surgical contra-indications were detected at CT evaluation, patients
      were involved in the study.
observational model: Case-Control
time perspective: Prospective
measure: height of augmented bone obtained
time frame: 6 months
description: the height of the gained bone was recorded by using the control CT scan, realized after 6 months of follow up
measure: Duration of the surgery
time frame: 1 day
description: both total and partial times of different surgical steps were recorded
measure: Post surgical patient's discomfort
time frame: 2 weeks
description: all patients were asked to fill out a VAS scale, graduated from 1 (minimal pain ) to 10 ( maximum pain)
arm group label: test side ( horizontal flap)
description: Horizontal incision was realised in alveolar mucosa, in order to obtain the exposure of the lateral wall of the maxillary sinus, thus accessing the sinus cavity
arm group label: control side ( standard flap)
description: Trapezoidal flap was realised, using a crestal incision and two deep vertical incisions extended in the fornix to expose the lateral wall of the maxillary sinus
intervention type: Procedure
intervention name: flap
description: after flap incision , the sinus cavity was opened and then the membrane raised up
arm group label: control side ( standard flap)
arm group label: test side ( horizontal flap)
other name: surgical approach
other name: Sinus augmentation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: marco ferrari, clinical director
role: Study Chair
affiliation: tuscan school of dental medicine, university of Firenze and Siena
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Firenze and Siena, Napoli, Italy
investigator full name: nicola baldini
investigator title: principal investigator