<?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>IRCT138902203893N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-29</date_registration>
      <primary_sponsor>Tabriz Faculty of Dentistry</primary_sponsor>
      <public_title>Comparative evaluation of the success rate of applying formocresol, 3Mixtatin and Mineral trioxide aggregatein pulpotomy of primary molars</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of the success rate of applying formocresol, 3Mixtatin and Mineral trioxide aggregatein pulpotomy of primary molars</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4032</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irreversible Pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: in Formocresol group , Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline, after cotton pellet soaked in formocresol was placed on the remaining pulp tissue.The cotton pellet was removed from the cavity, a layer of reinforced-zinc oxide eugenol  was then placed on the root pulp and the tooth was restored with amalgam. Intervention 2: in 3Mixtatin group, Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline. The cotton pellet was removed from the cavity, a layer of 3mixtatin( were  mixed with normal saline)  was then placed on the root pulp and the tooth was restored with amalgam. Intervention 3: in Mineral trioxide aggregate group (MTA), Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline. The cotton pellet was removed from the cavity, a layer of MTA was then placed on the root pulp and the tooth was restored with amalgam.</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. Vajihe Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz Faculty of Dentistry</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3440 5872</telephone>
        <email>vajihehalavi@gmail.com</email>
        <affiliation>Tabriz Faculty of Dentistry</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Naser Aminabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz Faculty of Dentistry</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3334 0310</telephone>
        <email>aslaminabadi@gmail.com</email>
        <affiliation>Tabriz Faculty of Dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Procedure, possible risks, as well as possible benefits will be thoroughly explained to the parents of the patients aged 3-6 years old and a written informed consent will be taken. Teeth have to had appropriate clinical and radiographic sign and symptoms:&#13;
1. Caries primary molars with vital pulp&#13;
2. No history of spontaneous &#13;
3. No swelling (of pulpal origin)&#13;
4. No fistula&#13;
5. No pathological tooth mobility&#13;
6. No pathologic external root resorption&#13;
7. No pathological internal root resorption&#13;
8. No periapical or interradicular radiolucency&#13;
9. No pulp calcifications&#13;
10. No excessive bleeding from the amputated radicular stumps.&#13;
11. No history of  nocturnal pain&#13;
12. No tenderness to percussion or palpation&#13;
13. Normal  gingival and periodontal condition&#13;
14. Absence of periapical or furcal radiolucencies&#13;
15. Complete physical and mental health&#13;
16. Available to be restored by amalgam or SSC  &#13;
17. Availability for 3 months follow up</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>Pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>in Formocresol group , Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline, after cotton pellet soaked in formocresol was placed on the remaining pulp tissue.The cotton pellet was removed from the cavity, a layer of reinforced-zinc oxide eugenol  was then placed on the root pulp and the tooth was restored with amalgam</i_keyword>
      <i_keyword>in 3Mixtatin group, Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline. The cotton pellet was removed from the cavity, a layer of 3mixtatin( were  mixed with normal saline)  was then placed on the root pulp and the tooth was restored with amalgam.</i_keyword>
      <i_keyword>in Mineral trioxide aggregate group (MTA), Following the removal of caries and exposure of the pulp, the coronal pulp tissue was removed.A sterile cotton pellet soaked in sterile saline. The cotton pellet was removed from the cavity, a layer of MTA was then placed on the root pulp and the tooth was restored with amalgam.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dental hard tissue formation. Timepoint: Before and 3 months after intervention. Method of measurement: Radiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before and 3 months after intervention. Method of measurement: Question and palpation.</sec_outcome>
      <sec_outcome>Mobility. Timepoint: Before and 3 months after intervention. Method of measurement: Palpation.</sec_outcome>
      <sec_outcome>Bone radiographic repair. Timepoint: Before and 3 months after intervention. Method of measurement: Radiography.</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>Tabriz Faculty of Dentistry</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-15</approval_date>
        <contact_name>Tabriz Institutional Review Board</contact_name>
        <contact_address>Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
