<?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>IRCT20110212005804N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>effect of laser on the pulp changes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of the use of the two types of Nd: YAG 1064 nm laser) (Er: YAG (2940 nm) on thermal 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>6</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36653</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are placed in a randomized 4-block  by the method of Balanced Block. The randomization process is performed by an individual other than the investigator, and information about the sample intervention is stored in  sealed envelopes in order to randomize the excel software, Blinding description: The patient is aware of the research process.
The analyzer is not aware of the investigation process.
The evaluator is not aware of the research process.</study_design>
      <phase>3</phase>
      <hc_freetext>pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: In the first group,. An Er: YAG laser will be used at 2940 nm wavelength lightweakter (LightWalker AT, Fotona, Ljubljana, Slovenia). The handpiece will be used for contact type (H14 C, Fotona, Slovenia). The fiber used is Cylinderry and its tip, with a length of 8 mm and a diameter of 3.1 mm. The settings for this mounting bracket are as follows: 1.2 W, 600 MJ, 2 Hz, Pulse Long without spray of weather. Intervention 2: Second invertion group:In the second group, a Nd: YAG laser with a wavelength of 1064 nm will use the LightWalker AT, Fotona, Ljubljana, Slovenia, which has the characteristics as follows: 0.2 millisecond pulses and 3 watts for 3 seconds The outer diameter of the fiber is 400 microns and its tip is 1 mm from the surface of the bracket and perpendicular to the bracket surface. After the prescribed period of radiation, the bracket device is removed with the plug-in.</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:
Readers of the published  article

Conditions:
In case of publish the article

Where to obtain:
Target journal

How to obtain:
Refer to the desired journal site

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>All the patients were in good health as determined by health history and verbal questioning.
All the participants are not allowed to take any kind of medications.
Teeth included in this study should not have any kind of restoration ,caries , hypocalcification or cracks.
Teeth should have normal reaction to cold test and this reaction will compare to the same tooth in the other quadrant.
Teeth should not be loose or have swelling in the soft tissue around and be sensitive to the percussion and palpation.
the radiographic findings of these teeth should be free from damage in PDL and the area around the root.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic problems modifying the treatment process and taking all kinds of systemic drugs will not be included in the study.
The teeth with cracks ,restorations ,caries  and  hypocalcification will not be included in the study.
If the tooth in the radiographic clinical examination shows the sign of any radicular lesion, it will be excluded.
The patient's sensitivity to cold, heat, or chewing pressure on the teeth that causes the teeth to fail to enter the study.</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: In the first group,. An Er: YAG laser will be used at 2940 nm wavelength lightweakter (LightWalker AT, Fotona, Ljubljana, Slovenia). The handpiece will be used for contact type (H14 C, Fotona, Slovenia). The fiber used is Cylinderry and its tip, with a length of 8 mm and a diameter of 3.1 mm. The settings for this mounting bracket are as follows: 1.2 W, 600 MJ, 2 Hz, Pulse Long without spray of weather</i_keyword>
      <i_keyword>Second invertion group:In the second group, a Nd: YAG laser with a wavelength of 1064 nm will use the LightWalker AT, Fotona, Ljubljana, Slovenia, which has the characteristics as follows: 0.2 millisecond pulses and 3 watts for 3 seconds The outer diameter of the fiber is 400 microns and its tip is 1 mm from the surface of the bracket and perpendicular to the bracket surface. After the prescribed period of radiation, the bracket device is removed with the plug-in.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Temperature changes. Timepoint: The temperature immediately after laser irradiation and removal of the bracket (TL) will be measured and recorded by the thermometer (Hanyoungnux, series, D55, Korea). The temperature will then be recorded in the intervals of one minute for 10 minutes (TL1 to TL10). Method of measurement: Immediately after the cavity is prepared, the temperature of the pulp will be measured (Taccess). Then, the temperature changes will be recorded as T1 to T10 for up to 10 minutes at 1 minute intervals. The temperature test was continued up to 2 minutes after the temperature was stabilized to ensure temperature stability and then the data were evaluated before the onset of the main treatment and recorded as the initial temperature before the radiation (TBase). After laser irradiation and debonding the brackets, the temperature will be measured immediately (T laser), and then the temperature will be recorded as TL1 to TL10 for up to 1 minute intervals.</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>Vice chancellor of research, Islamic Azad University of medical scinces</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>
