xml: <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/NCT05987943</url>
    </required_header>
    <id_info>
      <org_study_id>R-OS-9-22-6</org_study_id>
      <nct_id>NCT05987943</nct_id>
    </id_info>
    <brief_title>A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula</brief_title>
    <official_title>Lecturer of Oral and Maxillofacial Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marwa Taha Ibrahim</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        The aim of this study is to evaluate both clinically and radiologically the efficacy of using&#xD;
        the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the&#xD;
        original intraoral anatomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Oroantral fistula (OAF) is a pathological communication between the oral cavity&#xD;
        and the maxillary sinus. A variety of surgical techniques have been developed, with&#xD;
        recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection.&#xD;
        To increase the success rates of OAF closure procedures, the use of double-layered closure&#xD;
        techniques has developed, but most of these techniques alter the original oral anatomy and&#xD;
        may result in significant postoperative morbidity.&#xD;
  &#xD;
        Purpose: The aim of this prospective study is to evaluate both clinically and radiologically&#xD;
        the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula&#xD;
        without affecting the original intraoral anatomy.&#xD;
  &#xD;
        Patients &amp; Methods: Ten patients with oroantral fistula will be included in this study. The&#xD;
        patients will be examined and managed at the Oral and Maxillofacial surgery Department,&#xD;
        Faculty of Dentistry, Tanta University.&#xD;
  &#xD;
        Preoperative evaluation: It will include the collection of demographic data, medical status&#xD;
        and relevant history of the OAF (etiology, duration, resonance of voice, regurgitation of&#xD;
        fluid, infection and previous surgical closure attempts). Cone beam computed tomography&#xD;
        (CBCT) scan will be performed to determine the size of the underlying bony defect.&#xD;
  &#xD;
        Surgical procedure: The buccal mucoperiosteal flap will be splitted horizontally into two&#xD;
        layers: a deep periosteal layer and a superficial buccal mucosa layer. The fistula tract will&#xD;
        transected at the bone level, the pedicled deep periosteal layer will be dissected and turned&#xD;
        over the fistula at the bone level and will be stabilized using sutures. The superficial&#xD;
        layer will be returned to its original position and sutured.&#xD;
  &#xD;
        Postoperative evaluation: The patients will be evaluated clinically each week for one month&#xD;
        regarding to healing, presence of infection, inflammation and recurrences.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">March 21, 2023</start_date>
    <completion_date type="Anticipated">September 21, 2023</completion_date>
    <primary_completion_date type="Actual">April 7, 2023</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>patients</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>visual analogue scale</measure>
      <time_frame>1 month</time_frame>
      <description>0 representing no pain and 10 representing the highest level of pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>comparison of vestibular depth preoperatively and postoperatively</measure>
      <time_frame>1 month</time_frame>
      <description>the vestibular depth measured from gingival margin to bottom of vestibule.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>inflammation score scale</measure>
      <time_frame>1 month</time_frame>
      <description>0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Oroantral Fistula</condition>
    <arm_group>
      <arm_group_label>healing.recurrence of oroanral fistula</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula</intervention_name>
      <description>A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula</description>
      <arm_group_label>healing.recurrence of oroanral fistula</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patients have oroantral fistula&#xD;
  &#xD;
            2. clear maxillary sinus with no infection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients suffering from any systemic diseases affect healing of soft tissue&#xD;
  &#xD;
            2. patients have remaining roots or foreign body in sinus indicated for cald well luc&#xD;
               opearation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marwa T Ibrahim, lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tanta University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Egypt</name>
        <address>
          <city>Tanta</city>
          <zip>3111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Marwa Taha Ibrahim</investigator_full_name>
      <investigator_title>principle investigator</investigator_title>
    </responsible_party>
    <keyword>oroantral fistula</keyword>
    <keyword>A Pedicled Buccal Periosteal Flap</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Oroantral Fistula</mesh_term>
      <mesh_term>Fistula</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987943
  org study id: R-OS-9-22-6
  nct id: NCT05987943
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate both clinically and radiologically the efficacy of using
        the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the
        original intraoral anatomy.
  Background: Oroantral fistula (OAF) is a pathological communication between the oral cavity
        and the maxillary sinus. A variety of surgical techniques have been developed, with
        recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection.
        To increase the success rates of OAF closure procedures, the use of double-layered closure
        techniques has developed, but most of these techniques alter the original oral anatomy and
        may result in significant postoperative morbidity.
  
        Purpose: The aim of this prospective study is to evaluate both clinically and radiologically
        the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula
        without affecting the original intraoral anatomy.
  
        Patients & Methods: Ten patients with oroantral fistula will be included in this study. The
        patients will be examined and managed at the Oral and Maxillofacial surgery Department,
        Faculty of Dentistry, Tanta University.
  
        Preoperative evaluation: It will include the collection of demographic data, medical status
        and relevant history of the OAF (etiology, duration, resonance of voice, regurgitation of
        fluid, infection and previous surgical closure attempts). Cone beam computed tomography
        (CBCT) scan will be performed to determine the size of the underlying bony defect.
  
        Surgical procedure: The buccal mucoperiosteal flap will be splitted horizontally into two
        layers: a deep periosteal layer and a superficial buccal mucosa layer. The fistula tract will
        transected at the bone level, the pedicled deep periosteal layer will be dissected and turned
        over the fistula at the bone level and will be stabilized using sutures. The superficial
        layer will be returned to its original position and sutured.
  
        Postoperative evaluation: The patients will be evaluated clinically each week for one month
        regarding to healing, presence of infection, inflammation and recurrences.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: patients
  primary purpose: Treatment
  masking: None (Open Label)
  measure: visual analogue scale
  time frame: 1 month
  description: 0 representing no pain and 10 representing the highest level of pain
  measure: comparison of vestibular depth preoperatively and postoperatively
  time frame: 1 month
  description: the vestibular depth measured from gingival margin to bottom of vestibule.
  measure: inflammation score scale
  time frame: 1 month
  description: 0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
  arm group label: healing.recurrence of oroanral fistula
  arm group type: Other
  description: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
  intervention type: Procedure
  intervention name: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
  description: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
  arm group label: healing.recurrence of oroanral fistula
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marwa T Ibrahim, lecturer
  role: Principal Investigator
  affiliation: Tanta University
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tanta University
  investigator full name: Marwa Taha Ibrahim
  investigator title: principle investigator
  mesh term: Oroantral Fistula
  mesh term: Fistula
  sharing ipd: No
  ipd description: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula