<?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>IRCT20200726048214N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Nasal Changes Following Maxillary Advancement with and without Impaction, Using 3D imaging</public_title>
      <acronym></acronym>
      <scientific_title>Nasal Soft Tissue Changes Following Maxillary Lefort I Advancement Osteotomy with and without Impaction ; using 3D Photogrammetry, A before and after Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50154</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Class III Malocclusion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Maxillary Lefort I advancement Osteotomy without Impaction, Patients will undergo conventional Maxillary Lefort I advamcement surgery without Impaction . 3D images of patient's faces before surgery and 4 months after surgery will be taken by a 3D Optical scanner. Intervention 2: Intervention group: Maxillary Lefort I advancement with Impaction Osteotomy, Patients will undergo conventional Maxillary Lefort I advamcement with Impaction surgery . 3D images of patient's faces before surgery and 4 months after surgery will be taken by a 3D light scanner.</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:
All data related to soft tissue variables of the nose will be available without mentioning the names, information and images of patients and only in the form of numerical data and related analyzes. It is worth mentioning that the biographical information of patients such as age, gender, race, etc. will be expressed without mentioning the names or pictures of the patients' faces.

When:
The data access period will start from the time the results are published.

To whom:
The data will be available to researchers working in academic and scientific institutions as well as to people working in industry.

Conditions:
1. Carrying out study and research in the field related to this study
2. Conducting review studies

Where to obtain:
Applicants for information and documentation can apply in the following ways:
1- Email to: Hamounsbi@gmail.com
2- Phone call with the contact number: 00989123807579

How to obtain:
Data and documentation are stored in obj and EXCEL files. Therefore, after confirming the request, these files will be provided to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamoun Sabri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 23 Amid St, Zaferanieh, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985955817</zip>
        <telephone>+98 21 2241 1626</telephone>
        <email>Hamounsbi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamoun Sabri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 23 Amid St, Zaferanieh, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985955817</zip>
        <telephone>+98 21 2241 1626</telephone>
        <email>Hamounsbi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Class III Malocclusion, Candidate for Lefort I Maxillary Advancement With or without Maxillary Impaction Surgery.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Congenital diseases
Cleft lip and palate and other syndromes
history of facial trauma
previous orthognathic surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.213</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malocclusion, Angle's class III</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: Maxillary Lefort I advancement Osteotomy without Impaction, Patients will undergo conventional Maxillary Lefort I advamcement surgery without Impaction . 3D images of patient's faces before surgery and 4 months after surgery will be taken by a 3D Optical scanner.</i_keyword>
      <i_keyword>Intervention group: Maxillary Lefort I advancement with Impaction Osteotomy, Patients will undergo conventional Maxillary Lefort I advamcement with Impaction surgery . 3D images of patient's faces before surgery and 4 months after surgery will be taken by a 3D light scanner.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nasal Soft Tissue Changes. Timepoint: Before Surgery and 4months Post-op. Method of measurement: The soft tissue variables will be extracted from the 3D images taken by the 3D face scanner and then their numerical values will be calculated by GOM Inspect 2019 software.</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>2019-02-18</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti Medical Sciences University</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
