<?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>IRCT20210606051499N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-22</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The uprighting of mandibular second molars in orthodontic patient</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial to compare the effect of the miniscrew-supported technique with conventional techniques in mandibular second molar uprighting in patients under orthodontic treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56728</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization will be used by random number table based on SAS (statistical analysis system), software. A list of sequentially number 1 to 10 will be created. This list will assign numbers randomly by computer. Patients are randomly assigned according to the numbers of this list. To conceal, we use Allocation concealment, using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, Blinding description: The patients who refer to the Dental Clinic of Mashhad, Faculty of Dentistry, Mashhad, Iran, are selected as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to the group allocation and the type of treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Orthodontic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive miniscrew-supported approach for the uprighting of mandibular second molars. In this method, a mini-screw is placed in the distal second molar, and without the need for anterior teeth placement appliance, the molar operation is performed only with the help of the number one wire. Intervention 2: Control group: The control group will receive the conventional Melsen method for the uprighting of mandibular second molars. In this method, a mini-screw is placed between the seventh and fifth teeth, and the apparatus is performed with the help of one spring, and the extraction is prevented with the help of the second wire.</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 obtained from the main outcomes of the study can be shared

When:
6 months after publishing the results

To whom:
The research data is exclusively accessible to the researchers working at universities and centers for scientific research

Conditions:
The research data is exclusively accessible to the researchers working at universities and centers for scientific research

Where to obtain:
Mostafa Entezari provides the data analysis to the applicants via email: mostafa.entezari91@gmail.com

How to obtain:
Applicants can send emails to him and receive a response within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3883 2300</telephone>
        <email>mostafa.entezari91@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Entezari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948959</zip>
        <telephone>+98 51 3883 2300</telephone>
        <email>mostafa.entezari91@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patients who have already lost their first molars
Cases whose second molars are inclined at least 30 degrees
The patients who are candidates for prosthetic treatment of the edentulous site.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Poor oral hygiene
History of using drug
Having systemic disease
Having hormonal imbalance
Furcation involvement</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fitting and adjustment of orthodontic device</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: The intervention group will receive miniscrew-supported approach for the uprighting of mandibular second molars. In this method, a mini-screw is placed in the distal second molar, and without the need for anterior teeth placement appliance, the molar operation is performed only with the help of the number one wire.</i_keyword>
      <i_keyword>Control group: The control group will receive the conventional Melsen method for the uprighting of mandibular second molars. In this method, a mini-screw is placed between the seventh and fifth teeth, and the apparatus is performed with the help of one spring, and the extraction is prevented with the help of the second wire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The time required for uprighting. Timepoint: Before and after the intervention. Method of measurement: Cone beam computed tomography, Orthopantomography and Periapical radiography images.</prim_outcome>
      <prim_outcome>Speed of uprighting. Timepoint: Before and after the intervention. Method of measurement: Cone beam computed tomography, Orthopantomography and Periapical radiography images.</prim_outcome>
      <prim_outcome>The rate of tooth extrusion. Timepoint: Before and after the intervention. Method of measurement: Cone beam computed tomography, Orthopantomography and Periapical radiography images.</prim_outcome>
      <prim_outcome>The bone formation rate in the mesial. Timepoint: Before and after the intervention. Method of measurement: Cone beam computed tomography, Orthopantomography and Periapical radiography images.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-15</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
