<?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>IRCT20191104045331N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of obturation materials on post endodontic pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Gutta-percha and Mineral Trioxide Aggregate on Post Endodontic Pain in Teeth with Asymptomatic Apical Periodontitis: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46195</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants will be divided into two groups using a permuted block randomization method. Randomization will be done using 25 blocks with a 4-factor design. In each factor of the block design two participants are assigned to the control group and two participants to the intervention group. Then 25 numbers, from 1 to 6 will be selected using randomization table. For allocation concealment, the type of groups will be given to participants according to the block order via opaque envelopes by a person who is not aware of the randomization procedure. The canals of the teeth will be filled with gutta-percha in the control group and MTA with gutta-percha in the intervention group, Blinding description: Using a pair of opaque glasses on participants' eyes during treatment so that the patients won't be able to see the treatment procedure.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Asymptomatic apical periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For teeth with asymptomatic apical periodontitis, after cleaning and shaping, root canal therapy will be done with a thickness of three to five millimeters of ProRoot Mineral Trioxide Aggregate (Dentsply) plug. The rest of the canal will be filled with gutta-percha (Meta Biomed). Intervention 2: Control group: For teeth with asymptomatic apical periodontitis ,after cleaning and shaping,  root canal therapy will be done with gutta-percha (Meta Biomed).</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:
Participants data (pain score, sex and involving jaw without names of participants), study protocol, statistical analysis plan, informed consent form and study report will be shared.

When:
Documents and data files will be available after publishing the article and will always be available.

To whom:
People working in academy institutions

Conditions:
Educational and research uses

Where to obtain:
From the library of Faculty of Dentistry Islamic Azad University of Isfehan (Khorasgan).

How to obtain:
A formal request should be given to the library of Faculty of Dentistry Islamic Azad University of Isfehan (Khorasgan) and the data will be given to them.

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahel Kamgar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfehan, East Jey street, Arghavaniye, Daneshgah Boulevard</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>Info@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbasali Khademi Mooghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfehan, Hezar jarib street, Isfehan University of Medical Sciences</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>a_khademi@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to read and to understand the questionaire
Singniture of the informed consent form
Patients between 18 to 65 years old
Tooth with asymptomatic apical periodontitis confirmed with cold test and radiography
Restorable tooth
Periapical index of 3, 4 or 5</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of a sinus tract
Mandibular second premolar
Retreatment cases
Usage of pain killer during the last 12 hours
Tooth with no occlusal contact</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic apical periodontitis</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: For teeth with asymptomatic apical periodontitis, after cleaning and shaping, root canal therapy will be done with a thickness of three to five millimeters of ProRoot Mineral Trioxide Aggregate (Dentsply) plug. The rest of the canal will be filled with gutta-percha (Meta Biomed).</i_keyword>
      <i_keyword>Control group: For teeth with asymptomatic apical periodontitis ,after cleaning and shaping,  root canal therapy will be done with gutta-percha (Meta Biomed).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of pain in the questionnaire. Timepoint: 6, 12, 24, 48 and 72 hours after intervention. Method of measurement: Visual Analogue 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-03</approval_date>
        <contact_name>Ethics committee of Islamic Azad University Isfahan (Khorasgan) Branch</contact_name>
        <contact_address>Islamic Azas Univesity of Isfehan (khurasgan) Branch, Isfehan, East Jey street, Arghavaniye, Daneshgah Boulevard Isfehan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
