<?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>IRCT20150107020601N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-10</date_registration>
      <primary_sponsor>International Campus - Tehran University of Medical Sciences Vice Dean for reasearch Affairs</primary_sponsor>
      <public_title>surgical guide in jaw surgery</public_title>
      <acronym></acronym>
      <scientific_title>A Comparative study to assess feasibility of computer assisted designed and fabricated surgical guides in  sagittal split osteotomy  vs. conventional sagittal split osteotomy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>9</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28601</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will have two study group, the side of mandibular ramus that will be treated by convention osteotomy (can be right or left) and the side that will be treated using the computer designed and manufactured surgical guide of same patient (the other side). For every patient the side of mandibular ramus will be selected by simple random sampling technique (tossing coin). The coin tossing will be used twice to select the side of mandible (right or left) and types of technique (surgical guide assist or conventional), Blinding description: In this study the participant, the outcome assessor and statistician will be blinded, they will not know what treatment is used for which side.  The treatment will be registered using a code known only to investigator.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Orthognatic surgery, feasibility of computer assisted designed and fabricated surgical guide in sagittal split ramus osteotomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  The Mandibular ramus side for which computer assisted designed and fabricated surgical guide will be used will intervention group.                                                                                           y. Intervention 2: Control group:  The side of Mandible that will be treated with conventional sagittal split osteotomy.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The work has not been started yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shimelis Megersa Gema</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital Oral and Maxillofacial Surgery Ward, block -5 Imam Khomeyni St., 31 Shahrivar Sq. , Tehran 1136746911 ,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6701 0419</telephone>
        <email>megersagema@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Amir Jalal Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital, Oral and  Maxillofacial Surgery Ward Block-5 Imam Khomeini St., 31 Shahrivar Sq. , Tehran,1136746911 ,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>113674691</zip>
        <telephone>+98 216701041</telephone>
        <email>Aj-abbasi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-35 years.
Patients that has  Mandibular sagittal split osteotomy in their treatment plan using virtual surgical planningit osteotomy in their treatment plan using virtual surgical planning</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients with a history of Trigeminal nerve Neurosensory disturbance
If genioplasty is included in treatment plan
Have medical condition associated with neuropathy (like Diabetic, Hypertension and Kidney problem
Those unwilling to sign informed consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mandibular hyperplasia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  The Mandibular ramus side for which computer assisted designed and fabricated surgical guide will be used will intervention group.                                                                                           y</i_keyword>
      <i_keyword>Control group:  The side of Mandible that will be treated with conventional sagittal split osteotomy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1.  Inferior Alveolar nerve neurosensory disturbance. Timepoint: 1.  Neurosensory disturbance   will be assessed at second week, first month and three month after operation. Method of measurement: A. Quantitative neurosensory testing   lower lip and chin                                                             1. Direction of brush stroke  using cotton                                                                                  2.Two point discrimination using needle                                                                                                3.Tactile threshold using Semmes–Weinstein (SW) monofilament                                              . 4. Temperature awareness by using a tube filled hot water or ice                                                                                      B. Subjective neurosensory testing using a visual analogue scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of osteotomy. Timepoint: Intraoperative. Method of measurement: minute.</sec_outcome>
      <sec_outcome>Unfavorbale fracture. Timepoint: intraoperative. Method of measurement: yes/ no.</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>International Campus - Tehran University of Medical Sciences Vice Dean for reasearch Affairs</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-15</approval_date>
        <contact_name>Tehran University of  Medical Sciences Vice  Chancellor for Research</contact_name>
        <contact_address>Block -226, Ghods St., Keshavarz Blvd, Tehran, 1414653761 Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
