<?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>IRCT2017062434726N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-31</date_registration>
      <primary_sponsor>Vice chancellor for research, Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of BMP2 versus MTA as a medicament in pulpotomy of primary molars</public_title>
      <acronym>-</acronym>
      <scientific_title>A comparative study of clinical and radiographic success rates of BMP2 and MTA in pulpotomy of primary molars in 3 to 6 year old children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26464</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The Split mouth design is applied in this study. Base on block randomization table all of the participants will be assigned to receive pulpotomy therapy with MTA in primary mandibular molars of one side and pulpotomy with BMP2 in primary mandibular molars of another side.</study_design>
      <phase>3</phase>
      <hc_freetext>reversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: َAfter pulpotomy treatment, 1 microgram  recombinant human bone morphogenetic protein 2 (rhBMP2) is placed in pulp chamber. Intervention 2: group2: After pulpotomy treatment, MTA paste  is placed in pulp chamber as a standard pulpotomy medicament.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sanaz Ziaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Department, Dental school, Esfahan University of Medical Sciences, Hezarjerib street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 5591</telephone>
        <email>sanaz20_2005@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sanaz Ziaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Department, Dental school, Esfahan University of Medical Sciences, Hezarjerib street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 5591</telephone>
        <email>sanaz20_2005@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Exposed vital tooth without signs and symptoms; Teeth with no clinical or radiographic evidence of pulp degeneration; The possibility of proper restoration of the tooth.                                                                                                                             Exclusion criteria: Teeth with signs and symptoms; Clinical or radiographic evidence of pulp degeneration; physiologic mobility; Evidence of any pathologial root resorption.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>reversible pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: َAfter pulpotomy treatment, 1 microgram  recombinant human bone morphogenetic protein 2 (rhBMP2) is placed in pulp chamber.</i_keyword>
      <i_keyword>group2: After pulpotomy treatment, MTA paste  is placed in pulp chamber as a standard pulpotomy medicament.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention, 3 months, 6months, 9months and 12 months after intervention. Method of measurement: clinical examination.</prim_outcome>
      <prim_outcome>Sensitive to percussion. Timepoint: before intervention, 3 months, 6months, 9months and 12 months after intervention. Method of measurement: clinical examination.</prim_outcome>
      <prim_outcome>Swelling. Timepoint: before intervention, 3 months, 6months, 9months and 12 months after intervention. Method of measurement: clinical examination.</prim_outcome>
      <prim_outcome>Sinus tract. Timepoint: before intervention, 3 months, 6months, 9months and 12 months after intervention. Method of measurement: clinical examination.</prim_outcome>
      <prim_outcome>Pathologic mobility. Timepoint: before intervention, 3 months, 6months, 9months and 12 months after intervention. Method of measurement: clinical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Internal resorption. Timepoint: before intervention, 3months, 6months, 9months and 12months after intervention. Method of measurement: radigraphic examination.</sec_outcome>
      <sec_outcome>External resorption. Timepoint: before intervention, 3months, 6months, 9months and 12months after intervention. Method of measurement: radigraphic examination.</sec_outcome>
      <sec_outcome>PDL widening. Timepoint: before intervention, 3months, 6months, 9months and 12months after intervention. Method of measurement: radigraphic examination.</sec_outcome>
      <sec_outcome>Radiolucency. Timepoint: before intervention, 3months, 6months, 9months and 12months after intervention. Method of measurement: radigraphic examination.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Kowsar Kohan Gen company</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 for research, Esfahan University of Medical Sciences</source_name>
      <source_name>Kowsar Kohan Gen company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-27</approval_date>
        <contact_name>Ethics committe of Esfahan University of Medical Sciences</contact_name>
        <contact_address>Ethics committe, Dental school, Esfahan University of Medical Sciences, Hezarjerib street, Esfahan Esfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
