<?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>IRCT20110212005804N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>effect of laser on pulp histology</public_title>
      <acronym></acronym>
      <scientific_title>comparison of the effect of the use of the two types of laser Nd:YAG(1064nm) and Er:YAG(2940nm) on histologic changes of the premolars human pulp during removal of ceramic brackets (clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomly allocated to double blocks using random-block technique. Random allocation will be done using Excel software by a blinded person who is not among the investigators and the intervention details will be kept in sealed and coded pockets. As a result patient allocation will be done based on age and gender. The pockets have 28 numbers for the first intervention groups and 28 numbers for the second intervention groups, Blinding description: The evaluation process is done by someone other than the practitioner who does the operation. He does not have access to patient's information, either. Moreover, histological evaluation is done in the absence of patient and the practitioner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Er: YAG laser with 2940 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The parameters are based on device pre-sets as follows: 1.2 W, 600 MJ, 2 Hz, lung pulse without air spray. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface. After radiation, the bracket is removed with a plugger. Intervention 2: Second invertion group: Nd: YAG laser with 1064 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The parameters are based on device pre-sets as follows: pulse length 0.2 millisecond and energy 3 watts for 3 seconds. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface. After radiation, the bracket is removed with a plugger.</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:
Only part of the data, such as the key outcome information or the like, can share.

When:
Start of access period 6 months after printing results

To whom:
Researchers and college students who are involved in the treatment of patients in common can use data

Conditions:
All the clinicians who use laser to debond ceramic brackets can access the documents using the following address.
dr.Mahta Fazlyab 
dr.mfazlyab@yahoo.com
Faculty of dentistry of Islamic Azad university 
+982122564571
No. 9,Faculty of dentistry of Islamic Azad university,9th Neyestan Ave,Pasdaran Ave

Where to obtain:
Applicants can contact the person responsible for the article to receive the information.
dr.Mahta Fazlyab 
dr.mfazlyab@yahoo.com
Faculty of dentistry of Islamic Azad university 
+982122564571
No. 9,Faculty of dentistry of Islamic Azad university,9th Neyestan Ave,Pasdaran Ave

How to obtain:
Demand by email to the person responsible for the article
dr.Mahta Fazlyab 
dr.mfazlyab@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mahta Fazlyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, 9th Neyestan Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>dr.mfazlyab@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mahta Fazlyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9,9th Neyestan Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>dr.mfazlyab@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with at least two premolar teeth in a single jaw that need to be extracted for orthodontic treatment.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic problems that modify the treatment procedure
Patients taking any systemic medicine
Teeth with cracks, existing restorations, caries and hypocalcification.
Any radicular lesion in clinical or radiographic examination
The tooth sensitivity to cold, heat, or bite pressure on the teeth</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulpitis</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>First intervention group: Er: YAG laser with 2940 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The parameters are based on device pre-sets as follows: 1.2 W, 600 MJ, 2 Hz, lung pulse without air spray. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface. After radiation, the bracket is removed with a plugger.</i_keyword>
      <i_keyword>Second invertion group: Nd: YAG laser with 1064 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The parameters are based on device pre-sets as follows: pulse length 0.2 millisecond and energy 3 watts for 3 seconds. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface. After radiation, the bracket is removed with a plugger.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Histologic changes. Timepoint: Immediately after laser irradiation and bracket debonding the teeth are extracted and sent for preparation and histological evaluation. Method of measurement: َThe specimens will be evaluated according to ISO7405 standard.</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>2018-12-31</approval_date>
        <contact_name>Ethics Committee, Faculty of Dentistry, Islamic Azad University</contact_name>
        <contact_address>No. 9,Faculty of Dentistry Islamic Azad University,9th neyestan Ave,Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
