<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/NCT04499144</url>
  </required_header>
  <id_info>
    <org_study_id>ODO002</org_study_id>
    <nct_id>NCT04499144</nct_id>
  </id_info>
  <brief_title>A Modified Approach for the Closure of Oral Sinus Communications</brief_title>
  <official_title>A Modified Approach for the Closure of Oral Sinus Communications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Siena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Siena</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>
      The aim of this study is to describe a modified surgical approach for the closure of oral&#xD;
      sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap&#xD;
      rotated from the palate&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Actual">July 27, 2020</completion_date>
  <primary_completion_date type="Actual">June 29, 2020</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>
    <intervention_model_description>case series of a new surgical design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Closure of the communication</measure>
    <time_frame>Day 30</time_frame>
    <description>Clinical observation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain and discomfort</measure>
    <time_frame>Day 30</time_frame>
    <description>These parameters are described using VAS technique</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Surgery Site Fistula</condition>
  <arm_group>
    <arm_group_label>modified buccal flap and subepithelial connective palatal flap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>modified buccal flap and subepithelial connective palatal flap</intervention_name>
    <description>The connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures.</description>
    <arm_group_label>modified buccal flap and subepithelial connective palatal flap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with diagnosis of Oro-antral communication&#xD;
&#xD;
          -  Patients with adequate radiographic status&#xD;
&#xD;
          -  Patients who read and signed the informed consent&#xD;
&#xD;
          -  Patients without periodontal disease&#xD;
&#xD;
          -  Patients≥18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding patients&#xD;
&#xD;
          -  Patients compliance and patients with mental disorders&#xD;
&#xD;
          -  Patients with diabetes&#xD;
&#xD;
          -  Patients with osteonecrosis&#xD;
&#xD;
          -  Patients with head and neck cancer&#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>Ralph Habib, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Siena</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Siena- Department of medical biotechnologies</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Siena</investigator_affiliation>
    <investigator_full_name>Ralph Habib</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Extraction</keyword>
  <keyword>Oro-antral communication</keyword>
  <keyword>Oro-antral fistula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fistula</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/NCT04499144
org study id: ODO002
nct id: NCT04499144
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to describe a modified surgical approach for the closure of oral
      sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap
      rotated from the palate
allocation: N/A
intervention model: Single Group Assignment
intervention model description: case series of a new surgical design
primary purpose: Treatment
masking: None (Open Label)
measure: Closure of the communication
time frame: Day 30
description: Clinical observation
measure: Pain and discomfort
time frame: Day 30
description: These parameters are described using VAS technique
arm group label: modified buccal flap and subepithelial connective palatal flap
arm group type: Experimental
intervention type: Procedure
intervention name: modified buccal flap and subepithelial connective palatal flap
description: The connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures.
arm group label: modified buccal flap and subepithelial connective palatal flap
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ralph Habib, Dr.
role: Principal Investigator
affiliation: University of Siena
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Siena
investigator full name: Ralph Habib
investigator title: Principal investigator
mesh term: Fistula