<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200620047836N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-07</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the amount of pain, edema and maximum mouth opening before and after the broken zygomatic arch reduction by new method</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the amount of pain, edema and maximum mouth opening before and after the broken zygomatic arch reduction by new method of using fifty mm needle without surgery cut</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Isolation fracture in zygomatic arch.</hc_freetext>
      <i_freetext>Intervention group: of all the patients suspected of having a zygomatic arch fracture who referred to Imam Reza Hospital in Tabriz and wish to participate in the study, as well as with one or more symptoms, including arch-like depression, non-opening of the mouth, pain and tenderness in the arch-like area, After obtaining informed consent, spiral, axial, and coronal CT scans will be received. In the operating room, after anesthesia under Ural intubation, the location of the arch will be determined by touch and marked with a marker. Two 50 mm needles are selected. The first needle is 15 mm in front of the tragus and the second needle is 30 mm in front of the tragus. They enter from the top of the arch and exit the lower part of the arch so that the tip of the needle is at the bottom of the arch and the end of the needle is at the top .The tips and ends of the needles are then removed by four separate needles and pulled out slowly and with gentle to moderate force to determine the touch of the reaction. Then, for external fixation, zero nylon thread is inserted from inside each needle and the needle is removed from the opposite side, and then the needles are removed and the thread along with an abslange will be used as external fixation..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Dalirakbari Azar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 20, Zaferanji alley., Beheshti intersection,. Imam avenue</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5173865955</zip>
        <telephone>+98 41 3553 2864</telephone>
        <email>zahradelirakbari@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Dalirakbari azar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 20, Zaferanji alley., Beheshti intersection,. Imam avenue</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5173865955</zip>
        <telephone>+98 41 3553 2864</telephone>
        <email>zahradelirakbari@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unilaterally or bilaterally fractures in zygomatic arch
Indication for surgery
Limitation in moth opening
Clinically depression in zygomatic arch</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Multiple fractures in zygomatic arch
Other fractures in nasal bone and midfaces
No bone contact
Uncontrolled systemic diseases
Visiting after 3 weeks</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S02.402</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Zygomatic fracture</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: of all the patients suspected of having a zygomatic arch fracture who referred to Imam Reza Hospital in Tabriz and wish to participate in the study, as well as with one or more symptoms, including arch-like depression, non-opening of the mouth, pain and tenderness in the arch-like area, After obtaining informed consent, spiral, axial, and coronal CT scans will be received. In the operating room, after anesthesia under Ural intubation, the location of the arch will be determined by touch and marked with a marker. Two 50 mm needles are selected. The first needle is 15 mm in front of the tragus and the second needle is 30 mm in front of the tragus. They enter from the top of the arch and exit the lower part of the arch so that the tip of the needle is at the bottom of the arch and the end of the needle is at the top .The tips and ends of the needles are then removed by four separate needles and pulled out slowly and with gentle to moderate force to determine the touch of the reaction. Then, for external fixation, zero nylon thread is inserted from inside each needle and the needle is removed from the opposite side, and then the needles are removed and the thread along with an abslange will be used as external fixation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of pain before and after the surgical procedure of zygomatic arch reduction with a 50 mm needle. Timepoint: Before and immediately after  surgery and 1 week later. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
      <prim_outcome>The amount of  edema before and after the broken zygomatic arch reduction by new method of using fifty mm needle without surgery cut. Timepoint: Before and immediately after  surgery and 1 week later. Method of measurement: The distance from the tragus to the corner of the eye and the distance from the tragus to the corner of the mouth by the ruler.</prim_outcome>
      <prim_outcome>The amount of  maximum mouth opening before and after the broken zygomatic arch reduction by new method of using fifty mm needle without surgery cut. Timepoint: Before and immediately after  surgery and 1 week later. Method of measurement: Maximum opening without any pressure or pain and Measure the distance between the incisal edge of the upper and lower front teeth with a ruler.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-08</approval_date>
        <contact_name>Rregional research ethics committee, Tabriz University of Medical Sciences</contact_name>
        <contact_address>3rd Floor, Central Building, University Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
