<?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>IRCT20230407057841N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-28</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the efficiency of the new miniscrew assisted method of protracting the mandibular second molars</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficiency of the new miniscrew assisted method of protracting the mandibular second molars in patients referred to the orthodontic department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69554</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The type of study is a clinical trial, which includes two control groups and patients. After the patients enter this study, they are randomly assigned to one of two intervention or control groups. The randomization of these patients will be simple randomization. Simple randomization is done by randomizer.org. Also, to conceal each person's chosen group, we write the relevant groups on paper and put them inside the envelope. Numbers are printed on the envelope according to the numbers generated by randomizer.org. Then people randomly pick one of the envelopes and are assigned to the group written inside the envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>mandibular first molar loss.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: two G2 Jeil 1.4 ⁕8 miniscrews will be placed in the mesial and distal of the second premolar tooth. Then uprighting is done with the help of a rectangular loop made of 17 ⁕25 mil TMA wire, which is placed in the screw slots, and after placing a T.Loop made of 17 ⁕25 mil TMA wire along with a 40 degree β bend and a bend Antirotation 30 degrees teeth are brought forward. Intervention 2: Control group: Conventionally, after the initial alignment and placing of the steel wire 25x19, a mini screw G2 Jeil 1.4 ⁕8 is placed between the 3rd and 4th teeth and connected to the 4th tooth with a ligature wire. We use Ni-Ti push coils to straighten the second molar. Then, this tooth is connected to tooth 4 with a Ni-Ti close coil spring from the buccal (bracket) and lingual (lingual button) sides with a force of 100 grams. Lingual force is applied to prevent the rotation of the second molar.</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 there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.fahimeh farzanegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakil Abad Blvd., corner of Park Square, Mashhad Dental College, Orthodontics Department</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>farzaneganf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.fahimeh farzanegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakil Abad Blvd., corner of Park Square, Mashhad Dental College, Orthodontics Department</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3882 9501</telephone>
        <email>farzaneganf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Orthodontic patients who have lost their mandibular first molars and the second molars are tilted to the edentulous area and need protraction.
15-25 years old
The buccolingual thickness of the bone in the edentulous area should be more than two thirds of the buccolingual thickness of the mesial root of the second molar.
Absence of systemic problems affecting bone metabolism
No smoking
Not taking drugs affecting bone metabolism</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient non-cooperation
Mini screw failure once</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: two G2 Jeil 1.4 ⁕8 miniscrews will be placed in the mesial and distal of the second premolar tooth. Then uprighting is done with the help of a rectangular loop made of 17 ⁕25 mil TMA wire, which is placed in the screw slots, and after placing a T.Loop made of 17 ⁕25 mil TMA wire along with a 40 degree β bend and a bend Antirotation 30 degrees teeth are brought forward</i_keyword>
      <i_keyword>Control group: Conventionally, after the initial alignment and placing of the steel wire 25x19, a mini screw G2 Jeil 1.4 ⁕8 is placed between the 3rd and 4th teeth and connected to the 4th tooth with a ligature wire. We use Ni-Ti push coils to straighten the second molar. Then, this tooth is connected to tooth 4 with a Ni-Ti close coil spring from the buccal (bracket) and lingual (lingual button) sides with a force of 100 grams. Lingual force is applied to prevent the rotation of the second molar</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mandibular second molar protraction speed. Timepoint: 6 months after molar protraction. Method of measurement: Comparison of the distance of the maximum convexity of the second molar and second premolar teeth in the initial and final opg photos.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The change of mandibular second molar angle with the mandibular border (in OPG images) before and after treatment. Timepoint: 6 months after protraction. Method of measurement: OPG photos prepared.</sec_outcome>
      <sec_outcome>Changes in rotation relative to the mandibular occlusion line (in study models) before and after treatment. Timepoint: 6 months after protraction. Method of measurement: OPG photos prepared.</sec_outcome>
      <sec_outcome>The amount of bone and its density in the mesial second molar (in CBCT images) before and after treatment. Timepoint: 6 months after protraction. Method of measurement: CBCT photos prepared.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-13</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>no.9,bahonar Ave.,vakilabad blvd.,mashhad town mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
