<?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>IRCT20170101031697N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-07</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the method of connecting the mandible to the zygomatic arch by wire for the treatment of recurrent temporomandibular joint dislocation</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Mandibular Wiring to Zygomatic Arch for Recurrent Tempro-Mandibular Joint Dislocation Treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>5</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Recurrent Tempro-Mandibular Joint Dislocation.</hc_freetext>
      <i_freetext>Intervention group: The intervention is surgical. During this surgery, by using a 0.6 mm stainless steel wire, their jaw movements will be limited. First, a hole is made in the anterior-posterior dimension, one centimeter posterior to the anterior border of the ascending mandible, and in the Superior-Inferior dimension, one centimeter above the Occlusal Plan, a hole is made. Then we bring the Owle from the medial side of the zygomatic arch to the medial area of ​​the ramus near the hole, then we tie a 0.6 mm stainless steel wire with the tip of the Owle, we pass the wire through the inside of the arch of the zygoma and from The outer area of ​​the zygomatic arch is cut to the outer part of the Ramos mandible near the hole. Then, by moving the wire back and forth a few times, we make sure that the wire is free and no tissue is stuck. Then we examine the amount of jaw opening, this amount of opening is examined clinically, this amount should be 5 mm less than the dislocation. At the end, the wire is brought to the specified size and we pass the outer end of the wire through the hole and tie the two ends of the wire on the inside of the ramus..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The information from this study can be shared without identifying participants.

When:
From October 2021

To whom:
Researchers and referees

Conditions:
Obtaining a written permit and mentioning the name in the sources and references

Where to obtain:
Afshin Parvizpanah
afshin.parvizpanah@hums.ac.ir

How to obtain:
The request must first be emailed and answered after review and approval.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afshin Parvizpanah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd.</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3333 6625</telephone>
        <email>afshin.parvizpanah@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hesamoddin Etemadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7914964153</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>mail@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient who has the recurrent Tempro-Mandibular joint dislocation problem.
Patient who has not received any other treatment to resolve the recurrent Tempro-Mandibular joint dislocation problem.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have been barred from any surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S03.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dislocation of jaw</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention is surgical. During this surgery, by using a 0.6 mm stainless steel wire, their jaw movements will be limited. First, a hole is made in the anterior-posterior dimension, one centimeter posterior to the anterior border of the ascending mandible, and in the Superior-Inferior dimension, one centimeter above the Occlusal Plan, a hole is made. Then we bring the Owle from the medial side of the zygomatic arch to the medial area of ​​the ramus near the hole, then we tie a 0.6 mm stainless steel wire with the tip of the Owle, we pass the wire through the inside of the arch of the zygoma and from The outer area of ​​the zygomatic arch is cut to the outer part of the Ramos mandible near the hole. Then, by moving the wire back and forth a few times, we make sure that the wire is free and no tissue is stuck. Then we examine the amount of jaw opening, this amount of opening is examined clinically, this amount should be 5 mm less than the dislocation. At the end, the wire is brought to the specified size and we pass the outer end of the wire through the hole and tie the two ends of the wire on the inside of the ramus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of mouth opening before surgery. Timepoint: Before surgery. Method of measurement: Measurements will be done using a ruler per millimeter.</prim_outcome>
      <prim_outcome>The amount of mouth opening after surgery. Timepoint: After surgery. Method of measurement: Measurements will be done using a ruler per millimeter.</prim_outcome>
      <prim_outcome>Success of treatment. Timepoint: After surgery. Method of measurement: Not to dislocate the temporomandibular joint again will be a sign of successful treatment.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-15</approval_date>
        <contact_name>Ethics Committee of Bandar Abbas University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Bandar Abbas University of Medical Sciences,Research Deputy Building, Shahid Mohammadi Hospital, Jomhoori Islami Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
