<?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>IRCT20210531051460N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-27</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect  of lasercision corticotomy on the rate of canine retraction</public_title>
      <acronym></acronym>
      <scientific_title>Determining the effect of laser corticotomy on canine tooth retraction rate Dez orthodontic patients of Yazd Shahid Sadoughi Dental School who need to remove the first maxillary premolars</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56648</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, a simple randomization method is used. The randomization unit is individual and the randomization tool is the use of a random number table in such a way that all people for whom the first premolars are extracted and are in the pre-retraction stage. A number is assigned. Then, in the randomization table, we close the eyes and select the starting point, and we proceed to the same row or column, and the numbers that are smaller than the total number of people are selected to the number of the sample size, ie 13 Let's reach. Sealed bags are used to randomize which side of the laser corticotomy is to be performed, Blinding description: In this study, the outcome assessor and the data analyst are blinded so that the canon retraction assessor and the data analyst are not aware of which side is performing the intervention and which is the control side. In this study, it is not possible to blind participants because our intervention is laser corticotomy.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The rate of canine tooth regression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the area of the extracted premolar tooth, one side of the maxilla is randomly performed with laser corticotomy. During one session using the er: yag laser, corticotomy is performed in this area and the canine retraction rate is assessed within four months and compared with the control group. Intervention 2: Control group: No intervention is performed in the area of the extracted premolars on the other side of the maxilla, and the amount of canine retraction in this sect is evaluated within four months and compared with the intervention group.</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:
After identifying individuals, it is possible to share all patient variables.

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

To whom:
Researchers working in academic and scientific institutes of prestigious scientific research journals.

Conditions:
In order to use the documents of this study for other studies and researches to apply the results.

Where to obtain:
Responsible person in this field Negin Karimi to the email address negin.karimi97@yahoo.com

How to obtain:
The applicant can send his/her request to the mentioned email address along with her introduction and the reason for the request, and receive the information as soon as possible (finally 7 to 10 days).

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Karimi Sardari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dahe Fajr Boulvard.Imam Reza street.Shahid Sadoughi university of medical science.Yazd.Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914881167</zip>
        <telephone>+98 35 3625 6975</telephone>
        <email>negin.karimi97@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Karimi Sardari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dahe Fajr Boulvard.Imam Reza street.Shahid Sadoughi university of medical science.Yazd.Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914881167</zip>
        <telephone>+98 35 3625 6975</telephone>
        <email>negin.karimi97@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with class l malocclusion who require bilateral maxillary first maxillary filling due to severe crowding or dental protrusion.
Patients with class II malocclusion with maxillary dentoalveolar protrusion who require bilateral maxillary first premolars and canine retraction as part of an orthodontic treatment plan (camouflage treatment).
Vital teeth with normal periodontium and no root resorption.
The presence of both the first and second maxillary molars.
Lack of systemic disease, craniofacial syndromes and deformities.
No previous orthodontic treatment.
Lack of facial asymmetry.
Periodontal health.
No history of anterior maxillary surgery.
Do not take drugs that affect orthodontic movements such as corticosteroids, hormonal therapy and tricyclic antidepressants.
No severe liver or kidney disease
Absence of systemic conditions such as diseases that are immunocompromised or blood disorders, diabetes, etc.
The natural structural shape of the canine.
Acceptable oral hygiene (index plate below 30%).
No  vitamin D deficiency or hyperparathyroidism and osteoporosis.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Poor oral hygiene
Patients treated with drugs that affect the orthodontic movement of teeth.
Patients whose canine and second molars have necrosis.</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: In the area of the extracted premolar tooth, one side of the maxilla is randomly performed with laser corticotomy. During one session using the er: yag laser, corticotomy is performed in this area and the canine retraction rate is assessed within four months and compared with the control group.</i_keyword>
      <i_keyword>Control group: No intervention is performed in the area of the extracted premolars on the other side of the maxilla, and the amount of canine retraction in this sect is evaluated within four months and compared with the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of canine regression. Timepoint: The first month, the second month, the third month and the fourth month after laser corticotomy. Method of measurement: First, a three-dimensional scan is prepared from the study casts prepared each month. The reference lines in the scans include the midpalatal ridge and the Roga line. The Roga line is drawn from the midpoint of the third Roga on the right side of the palate perpendicular to the midline.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anchorage loss. Timepoint: Pain score. Method of measurement: vitality test.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-12</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Dahe Fajr Boulevard.Imam Reza Street.Shahid Sadoughi university of medical science.Yazd.Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
