<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/NCT03278041</url>
  </required_header>
  <id_info>
    <org_study_id>454</org_study_id>
    <nct_id>NCT03278041</nct_id>
  </id_info>
  <brief_title>Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis</brief_title>
  <official_title>Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis on the Quality of Life in Patients With Palatal Defects. (Randomized Controlled Clinical Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare maxillary obturator versus submental artery flap after&#xD;
      partial maxillectomy in the aspect of Quality of life outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The maxillary defects created by surgical removal of tumors result in communication between&#xD;
      the oral and nasal cavities that in turn impair speech, swallowing, mastication, and facial&#xD;
      esthetics, all of which consequently affect social behavior and quality of life (QoL).&#xD;
      Consequently, the QoL need to be evaluated in patients with head and neck cancer because&#xD;
      surgical resections and associated problems can affect QoL in significant ways.&#xD;
&#xD;
      University of Washington Head and Neck questionnaire is one of the measuring tools of the&#xD;
      Quality of life, this UW-QOL questionnaire tests 12 domains relating to the patient with head&#xD;
      and neck cancer. The sum score is calculated by adding together the scores for the 12 domains&#xD;
      and dividing by 12 for a score from 0 (for poor health) to 100 (good health).&#xD;
&#xD;
      The maxillary defects reconstruction could be approached with prosthetic obturators&#xD;
      rehabilitation or through surgical correction.&#xD;
&#xD;
      The obturator prostheses have many advantages that include; the easy visualization of the&#xD;
      defect site, which allows for the detection of cancer recurrence; a reduction in the&#xD;
      hospitalization period and costs; the ability to avoid a second operation; and the immediate&#xD;
      re-establishment of facial morphology and oral functioning.However, several disadvantages to&#xD;
      the maxillary obturator exist, including the discomfort of wearing a prosthesis, the&#xD;
      inconvenience of removing and cleaning the prosthesis, the inability to successfully retain a&#xD;
      prosthesis when the defect is large or when dentition is lacking, and the frequent need for&#xD;
      readjustments by a prosthodontist.&#xD;
&#xD;
      The surgical intervention could be with various approaches that provide the reconstruction of&#xD;
      communication and yields good results for the reconstruction of small defects.&#xD;
&#xD;
      The most commonly used surgical technique is the free tissue transfers that associated with&#xD;
      increased hospital time and flap donor area morbidity. Nonetheless, Study conducted by Rogers&#xD;
      et al., compared obturator prosthesis versus free flap surgical repair of the maxillary&#xD;
      defect, the result revealed that there were no statistically significant differences were&#xD;
      found between the two groups regarding quality of life measured with UW-QOL, although there&#xD;
      was a tendency for obturator patients to indicate more problems with appearance. In this&#xD;
      study, the obturator group recorded UW-QOL mean of 74±8.&#xD;
&#xD;
      The drawbacks of previous techniques have led to a search for alternate solutions, the use of&#xD;
      a pedicle submental artery island flap is introduced as a new surgical option for head and&#xD;
      neck tumor reconstruction. The advantages of this approach coming from its donor site can be&#xD;
      performed in very thin section, pliability, and versatility in design. Moreover, the&#xD;
      submental flap can be easily raised and involves shorter operative and hospital time compared&#xD;
      to the free-flap procedure.&#xD;
&#xD;
      The pedicle submental artery island flap can be an excellent choice in patients with a high&#xD;
      American Society of Anesthesiologists (ASA) risk score; moreover, this modality is effective&#xD;
      in elderly patients, where the potential complications linked to microsurgical procedures are&#xD;
      avoided.&#xD;
&#xD;
      There is no published study until now comparing pedicle submental artery island flap with&#xD;
      prosthetic obturators. So that the aim of this study is to answer the following question&#xD;
      &quot;After partial maxillectomy in patients with a palatal defect, Does the submental artery flap&#xD;
      offer different effect on the improvement of the quality of life when compared to maxillary&#xD;
      obturator?&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 30, 2018</start_date>
  <completion_date type="Anticipated">January 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>None (Open Label)</masking>
    <masking_description>Because the two interventions used in this trial are clearly different and easly recognized by the participants and investigators, neither investigator AlAdashi O nor Participants can be blinded.&#xD;
Similarly, the Assessor (Participants) can't be blinded. The statistician will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>one months post operative</time_frame>
    <description>measured by University of Washington Head and Neck questionnaire(UW-QOL).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Patient With Partial Maxillectomy</condition>
  <condition>Submental Island Flap</condition>
  <condition>Maxillary Obturator</condition>
  <arm_group>
    <arm_group_label>surgical reconstruction with submental flap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>surgical reconstruction with submental flap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>maxillary obturator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>maxillary obturator</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Submental flap for palatal reconstruction</intervention_name>
    <description>Under General Anesthesia the tumor in the maxilla will be resected (partial maxillectomy) with a safety margin, then the defect will be reconstructed immediately by :&#xD;
Submental artery flap : from submental area with 1 cm distance from inferior mandibular border in paddle shape.&#xD;
1st step will be identify the facial artery and vein,&#xD;
2nd step dissection and extend toward midline in subplatsmal plane. The flap contains submental artery and vein.&#xD;
3rd step creating submucous tunnel between vestibular border of post maxillectomy defect and to extraoral incision .&#xD;
The flap will be through the oral cavity and will be anchored to the intact remaining hard plate with bone sutures by 2-0 vicryl® suture.</description>
    <arm_group_label>surgical reconstruction with submental flap</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>maxillary obturator</intervention_name>
    <description>immediate surgical obturator</description>
    <arm_group_label>maxillary obturator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects were required:&#xD;
&#xD;
          1. All patients suffering from midface defects that involving palatal-maxillary bone are&#xD;
             included.&#xD;
&#xD;
          2. All ages and both sexes were included in this study.&#xD;
&#xD;
          3. Patients with good general condition allowing major surgical procedure under general&#xD;
             anesthesia.&#xD;
&#xD;
          4. Be physically and psychologically able to tolerate procedures.&#xD;
&#xD;
          5. Be cooperative to return for follow-up, examinations and evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient who physically and psychologically not able to tolerate procedures. Because&#xD;
             they cannot able to tolerate procedures and may discontinue the follow-up visits.&#xD;
&#xD;
          2. Be Uncooperative to return for follow-up, examinations and evaluation.&#xD;
&#xD;
          3. Patients with any systemic disease (e.g uncontrolled diabetic, bisphosphonates …..ect)&#xD;
             because that may affect normal healing.&#xD;
&#xD;
          4. Patient with bad oral hygiene.Because poor oral hygiene can cause inflammation which&#xD;
             induces pain that effect outcome reading.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>omar Q Aladashi, Master</last_name>
    <phone>00201154639509</phone>
    <email>omraladashi@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of dentistry-cairo university</name>
      <address>
        <city>Cairo</city>
        <zip>311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>omar q aladashi, master</last_name>
      <phone>00201154639509</phone>
      <email>omraladashi@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>OMAR ALADASH</investigator_full_name>
    <investigator_title>Principle Investigator</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/NCT03278041
org study id: 454
nct id: NCT03278041
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study is to compare maxillary obturator versus submental artery flap after
      partial maxillectomy in the aspect of Quality of life outcomes.
The maxillary defects created by surgical removal of tumors result in communication between
      the oral and nasal cavities that in turn impair speech, swallowing, mastication, and facial
      esthetics, all of which consequently affect social behavior and quality of life (QoL).
      Consequently, the QoL need to be evaluated in patients with head and neck cancer because
      surgical resections and associated problems can affect QoL in significant ways.

      University of Washington Head and Neck questionnaire is one of the measuring tools of the
      Quality of life, this UW-QOL questionnaire tests 12 domains relating to the patient with head
      and neck cancer. The sum score is calculated by adding together the scores for the 12 domains
      and dividing by 12 for a score from 0 (for poor health) to 100 (good health).

      The maxillary defects reconstruction could be approached with prosthetic obturators
      rehabilitation or through surgical correction.

      The obturator prostheses have many advantages that include; the easy visualization of the
      defect site, which allows for the detection of cancer recurrence; a reduction in the
      hospitalization period and costs; the ability to avoid a second operation; and the immediate
      re-establishment of facial morphology and oral functioning.However, several disadvantages to
      the maxillary obturator exist, including the discomfort of wearing a prosthesis, the
      inconvenience of removing and cleaning the prosthesis, the inability to successfully retain a
      prosthesis when the defect is large or when dentition is lacking, and the frequent need for
      readjustments by a prosthodontist.

      The surgical intervention could be with various approaches that provide the reconstruction of
      communication and yields good results for the reconstruction of small defects.

      The most commonly used surgical technique is the free tissue transfers that associated with
      increased hospital time and flap donor area morbidity. Nonetheless, Study conducted by Rogers
      et al., compared obturator prosthesis versus free flap surgical repair of the maxillary
      defect, the result revealed that there were no statistically significant differences were
      found between the two groups regarding quality of life measured with UW-QOL, although there
      was a tendency for obturator patients to indicate more problems with appearance. In this
      study, the obturator group recorded UW-QOL mean of 74±8.

      The drawbacks of previous techniques have led to a search for alternate solutions, the use of
      a pedicle submental artery island flap is introduced as a new surgical option for head and
      neck tumor reconstruction. The advantages of this approach coming from its donor site can be
      performed in very thin section, pliability, and versatility in design. Moreover, the
      submental flap can be easily raised and involves shorter operative and hospital time compared
      to the free-flap procedure.

      The pedicle submental artery island flap can be an excellent choice in patients with a high
      American Society of Anesthesiologists (ASA) risk score; moreover, this modality is effective
      in elderly patients, where the potential complications linked to microsurgical procedures are
      avoided.

      There is no published study until now comparing pedicle submental artery island flap with
      prosthetic obturators. So that the aim of this study is to answer the following question
      "After partial maxillectomy in patients with a palatal defect, Does the submental artery flap
      offer different effect on the improvement of the quality of life when compared to maxillary
      obturator?"
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Because the two interventions used in this trial are clearly different and easly recognized by the participants and investigators, neither investigator AlAdashi O nor Participants can be blinded.
Similarly, the Assessor (Participants) can't be blinded. The statistician will be blinded.
measure: Quality of life
time frame: one months post operative
description: measured by University of Washington Head and Neck questionnaire(UW-QOL).
arm group label: surgical reconstruction with submental flap
arm group type: Experimental
description: surgical reconstruction with submental flap
arm group label: maxillary obturator
arm group type: Active Comparator
description: maxillary obturator
intervention type: Procedure
intervention name: Submental flap for palatal reconstruction
description: Under General Anesthesia the tumor in the maxilla will be resected (partial maxillectomy) with a safety margin, then the defect will be reconstructed immediately by :
Submental artery flap : from submental area with 1 cm distance from inferior mandibular border in paddle shape.
1st step will be identify the facial artery and vein,
2nd step dissection and extend toward midline in subplatsmal plane. The flap contains submental artery and vein.
3rd step creating submucous tunnel between vestibular border of post maxillectomy defect and to extraoral incision .
The flap will be through the oral cavity and will be anchored to the intact remaining hard plate with bone sutures by 2-0 vicryl® suture.
arm group label: surgical reconstruction with submental flap
intervention type: Device
intervention name: maxillary obturator
description: immediate surgical obturator
arm group label: maxillary obturator
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: omar Q Aladashi, Master
phone: 00201154639509
email: omraladashi@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: OMAR ALADASH
investigator title: Principle Investigator
sharing ipd: Undecided