<?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>IRCT20200328046884N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-29</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>mineral trioxide aggregate(MTA), calcium-enriched mixture (CEM) cement and Calcium hydroxide in pulpotomized primary molar with laser</public_title>
      <acronym></acronym>
      <scientific_title>Clinical and radiographic assessment of the success of pulpotomy of primary molars with diode laser and three different capping agents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46852</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>primary molar pulpotomy.</hc_freetext>
      <i_freetext>Intervention 1: . Intervention 2: Intervention group: In group 1, diode laser with red light (Mustang 2000; Russia), KLO4 output nozzle with 0.5 cm2 cross-sectional area, 30 mW maximum power, and 632 nm continuous-wave mode was used after hemostasis. The tip of the output nozzle was positioned over the pulp chamber with 2 mm distance from the canal orifice (non-contact mode), and laser was irradiated for 2 min and 15 s at 4 J/cm2 energy density. The pulp chamber was then capped with CH followed by reinforced zinc oxide eugenol (ZOE) and the tooth received a SSC. In group 2, laser was irradiated after hemostasis as explained for group 1, and then CEM cement (Bionique Dent, Tehran, Iran) was applied over the pump chamber followed by reinforced ZOE and the tooth received a SSC.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roza Haghgoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>W. Italy street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>18155/159</zip>
        <telephone>+98 21 5121 5080</telephone>
        <email>taghizadefateme@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roza Haghgoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>W. Italy street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>18155/159</zip>
        <telephone>+98 21 5121 5080</telephone>
        <email>haghgoodent@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>mental and physical health</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>uncooperative child or parents</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></i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword></i_keyword>
      <i_keyword>Intervention group: In group 1, diode laser with red light (Mustang 2000; Russia), KLO4 output nozzle with 0.5 cm2 cross-sectional area, 30 mW maximum power, and 632 nm continuous-wave mode was used after hemostasis. The tip of the output nozzle was positioned over the pulp chamber with 2 mm distance from the canal orifice (non-contact mode), and laser was irradiated for 2 min and 15 s at 4 J/cm2 energy density. The pulp chamber was then capped with CH followed by reinforced zinc oxide eugenol (ZOE) and the tooth received a SSC. In group 2, laser was irradiated after hemostasis as explained for group 1, and then CEM cement (Bionique Dent, Tehran, Iran) was applied over the pump chamber followed by reinforced ZOE and the tooth received a SSC.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical and radiographic assessment of the success of pulpotomy of primary molars. Timepoint: The teeth were evaluated clinically and radiographically before treatment and after 9, 18 and 36 months by a pediatric dentist who was blinded. Method of measurement: Zurn and Seale scale.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-08</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Persian Gulf Highway (Tehran - Qom), facing the holy shrine Imam Khomeini, Shahed University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
