<?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>IRCT20211029052908N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-26</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of two suturing methods to collect nasal base after maxillofacial orthognathic surgery(Maxillofacial correction surgery)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two cinch suturing techniques (classic &amp; reinsertion) in preventing interalar widening before and six months after maxilla orthognathic surgery (advancement, impaction, advancement and simultaneous impaction)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Skeletal Deformity of Jaws.</hc_freetext>
      <i_freetext>Intervention 1: alar cinch suture will be used by classic method and reinsertion cinch. For this purpose, a 33 mm needle with 2-0 Nylon monofilament thread of LINX brand made in India is used. In the classic method: the mucosa and muscle on one side are taken with nylon thread 2_0, then the mucosa and muscle on the opposite side are taken directly without touching the skin of the muscle and mucosa on both sides and pulled together. Intervention 2: Intervention group: alar cinch suture will be used by classic method and reinsertion cinch. For this purpose, a 33 mm needle with 2-0 Nylon monofilament thread of LINX brand made in India is used. In the reinsertion method: mucosa and The muscle on one side of the baselar is taken from inside the mouth and the needle comes out of the skin of the baselar area on one side and enters from the same area, and then the mucus, muscle and skin of the other side are taken in this way and finally The two sides of the base are pulled together and swing in the midline.</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:
Comparison of two techniques (classic &amp; reinsertion cinch suturing) in preventing interalar widening before and six months after maxilla orthognathic surgery (advancement, impaction, advancement and simultaneous impaction) in patients referred to Bo Ali Hospital

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
There is no other special case

Where to obtain:
To the faculty research site at www.ris.iau.ac.ir

How to obtain:
To the faculty research site at www.ris.iau.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedhossein Mirpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyestan 9,Pasdaran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2621 5676</telephone>
        <email>Dr.shmirpoor @gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedhossein Mirpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyestan 9,Pasdaran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2621 5676</telephone>
        <email>Dr.shmirpoor @gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients older than 16 years who have completed written consent
Undergo orthognathic surgery including LeFort 1 maxillary osteotomy
Patients with advancements less than 5 mm and impactions less than 4 mm.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with cleft lip or palate or another congenital disorder.
Patients with a history of maxillary surgery that may affect soft tissue due to scar tissue
Patients with advancements greater than 5 mm and impactions greater than 4 mm</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>alar cinch suture will be used by classic method and reinsertion cinch. For this purpose, a 33 mm needle with 2-0 Nylon monofilament thread of LINX brand made in India is used. In the classic method: the mucosa and muscle on one side are taken with nylon thread 2_0, then the mucosa and muscle on the opposite side are taken directly without touching the skin of the muscle and mucosa on both sides and pulled together.</i_keyword>
      <i_keyword>Intervention group: alar cinch suture will be used by classic method and reinsertion cinch. For this purpose, a 33 mm needle with 2-0 Nylon monofilament thread of LINX brand made in India is used. In the reinsertion method: mucosa and The muscle on one side of the baselar is taken from inside the mouth and the needle comes out of the skin of the baselar area on one side and enters from the same area, and then the mucus, muscle and skin of the other side are taken in this way and finally The two sides of the base are pulled together and swing in the midline.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interalar width: The width of the base of the nose is the distance between the most prominent point on both sides of the blade of the nose, the ideal position of which should be 1 mm more than the distance between the two inner cantons of the eyes. Timepoint: Six months after surgery. Method of measurement: Patients are divided into three groups based on the type of Lefort surgery: advancement, impaction, advancement, and simultaneous impaction (17). Then, six months after the surgery, patients are asked to go to Bouali Hospital and the interalar width is re-measured blindly by a specialist assistant. Third party assistant (except surgical team and project manager) is used after intra-surgical operation.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-14</approval_date>
        <contact_name>Ethics Committee of Tehran Azad University of Medical Sciences</contact_name>
        <contact_address>Neystan 9, Pasdaran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
