<?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>IRCT20210621051653N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-04</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Assesment  of rotated teeth relapse after orthodontic treatment via fibrotomy with scalpel and diode laser: A Randomized clinical trail</public_title>
      <acronym></acronym>
      <scientific_title>Assesment  of rotated teeth relapse after orthodontic treatment via fibrotomy with scalpel and diode laser: A Randomized clinical trail</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57091</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: From the samples with inclusion criteria, 90 rotated teeth are selected by the census. After recording the demographic information of patients, including age, sex, location, contact number, etc., using the blocking method, these 90 teeth will be assigned to six groups. The random allocation process will be done with Random allocation software. With this software, 15 six-block blocks are selected and the samples are divided into six groups based on these blocks. This is a one-sided blind study in which the person recording the rate of rotation and pain and the statistician do not know who is in which group and are not aware of the type of treatment. The patient and the treating specialist are aware of the treatment used and cannot be blinded, Blinding description: This is a one-sided blind study in which the person recording the rate of rotation and pain and the statistician do not know who is in which group and are not aware of the type of treatment. The patient and the treating specialist are aware of the treatment used and cannot be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The rate of relapse after orthodontic treatment with fibrotomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Fibrotomy with a surgical razor. Intervention 2: Intervention group: Low power laser fibrotomy only (by Biolase EPIC X laser diode USA, wavelength 940 nm). Intervention 3: Intervention group: Laser Fibrotomy with Surgical Laser Alone (Biolase EPIC X Laser Diode USA). Intervention 4: Intervention group: Fibrotomy with Laser surgery combined with low power laser. Intervention 5: Intervention group: Perform fibrotomy first and then low power diode laser radiation. Intervention 6: Control group: without interfering.</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 data file of the participants will generally be sent along with the submission of the research article after being unidentifiable
The study protocol will be fully explained in the text of the article
The cases and map of statistical analysis and the results that need to be mentioned in the text of the article are given
Patients' informed consent form must be published as an attachment
The report of what will be seen in the clinic will be mentioned as results in the text of the article.

When:
From 2021 to one year after the publication of the results

To whom:
Journal Referees. Anyone who intends to conduct further studies in this field will receive the documentation by sending an email to the responsible author.

Conditions:
People who want to do further studies in this field.
There is no obstacle

Where to obtain:
corresponded author
Avideh Maboudi
 Avideh48188@yahoo.com

How to obtain:
It does not take much time. It may take up to a week to send you an email right after we receive it

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>avideh maboudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Panzdah khordad Ave</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818865454</zip>
        <telephone>+98 11 3326 3345</telephone>
        <email>Avideh48188@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Avideh Maboudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Panzdah khordad Ave</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4818865454</zip>
        <telephone>+98 11 3326 3345</telephone>
        <email>Avideh48188@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing fixed orthodontic treatment who were 15 to 30 years old at the beginning of treatment and had rotated teeth and are now at the end of their fixed treatment should have a rotation rate of 20 to 70 degrees.
Absence of systemic disease
Absence of gingivitis and periodontitis, good oral hygiene, plaque index below 10%
Absence of proximal caries and deep caries in the area of ​​cementoenamel junction (CEJ), absence of evolutionary and anatomical deformities
Do not take drugs that disrupt bone metabolism
Lack of conditions in which the use of lasers is prohibited, such as pregnancy</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Teeth with periodontitis
Tooth rotations greater than 70 degrees and less than 20 degrees
Teeth with proximal caries or caries extending to the cementoenamel junction (CEJ)
Taking drugs that affect bone metabolism</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>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Fibrotomy with a surgical razor</i_keyword>
      <i_keyword>Intervention group: Low power laser fibrotomy only (by Biolase EPIC X laser diode USA, wavelength 940 nm)</i_keyword>
      <i_keyword>Intervention group: Laser Fibrotomy with Surgical Laser Alone (Biolase EPIC X Laser Diode USA)</i_keyword>
      <i_keyword>Intervention group: Fibrotomy with Laser surgery combined with low power laser</i_keyword>
      <i_keyword>Intervention group: Perform fibrotomy first and then low power diode laser radiation</i_keyword>
      <i_keyword>Control group: without interfering</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of relapse after orthodontic treatment with fibrotomy. Timepoint: The beginning of the study, one month after starting treatment. Method of measurement: Digimizer image analysis software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depth of gingival sulcus. Timepoint: The beginning of the study, one month after treatment. Method of measurement: Using a periodontal probe.</sec_outcome>
      <sec_outcome>Depth of probing around the teeth. Timepoint: The beginning of the study, one month after treatment. Method of measurement: Using a periodontal probe.</sec_outcome>
      <sec_outcome>The amount of pain. Timepoint: The beginning of the study, one month after treatment. Method of measurement: VAS scale.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-11</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Science</contact_name>
        <contact_address>Narenj alley , Panzdah Khordad Ave Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
