<?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>IRCT201102145804N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-08-12</date_registration>
      <primary_sponsor>Vice chancellor for research of Islamic Azad University, Dental Branch, Tehran</primary_sponsor>
      <public_title>Partial pulpotomy on caries free human teeth using iRootBP and White ProRoot MTA: a randomized controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Partial pulpotomy on caries free human teeth using iRootBP and White ProRoot MTA: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6289</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>pulp inflammation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Partial pulpotomy using iRoot BP.&#13;
Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tanthalium oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste). Intervention 2: control group: partial pulpotomy using White ProRoot MTA.&#13;
 Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.</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>Mahta Fazlyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>number 4, 10th Neyestan, Pasdaran st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2275 2019</telephone>
        <email>Dr.mfazlyab@gmail.com</email>
        <affiliation>Islamic Azad University, Dental Branch, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahta Fazlyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>number 4, 10th Neyestan, Pasdaran st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2275 2019</telephone>
        <email>dr.mfazlyab@gmail.com</email>
        <affiliation>Islamic Azad University, Dental Branch, Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan will be included; Their parents need to read and sign a fully informed form; They shouldn't have any systematic complication or take any medicine during the period of study; The teeth need to be free of any symptom, caries and decalcification; They should give a normal response to pulp sensitivity tests (cold test) compared to the  control tooth on the same quadrant; The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion; On radiographic examination no apical lucency or PDL widening should be detected.&#13;
Exclusion criteria: Any sign of crack; filling; caries or hypocalcification on teeth will cause exclusion. Also the teeth showing apical lucency or PDL widening will be excluded; Any sensitivity to cold, heat or bite will lead to exclusion; The responses beyond the normal limits to pulp vitality testing and any medicine consumption would cause exclusion.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Necrosis of pulp</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Partial pulpotomy using iRoot BP.&#13;
Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tanthalium oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).</i_keyword>
      <i_keyword>control group: partial pulpotomy using White ProRoot MTA.&#13;
 Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dentinal bridge formation. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation.</prim_outcome>
      <prim_outcome>Appearance of the dentinal bridge compared to normal dentin. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation of appereance of the dentinal bridge compared to normal dentin.</prim_outcome>
      <prim_outcome>Thickness of the dentinal bridge compared to normal dentin. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation of thickness of the dentinal bridge compared to normal dentin.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inflammatory status of the pulp. Timepoint: six weeks after intervention. Method of measurement: microscopic evaluation : inflammatory cell count and their distribution.</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 for research of Islamic Azad University, Dental Branch, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-16</approval_date>
        <contact_name>Ethic committee of Islamic Azad University, Dental Branch, Tehran</contact_name>
        <contact_address>No 4, 10th neyestan, Pasdaran street,Tehran,Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
