<?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>IRCT138903264196N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-19</date_registration>
      <primary_sponsor>Shiraz university of Medical Scienced</primary_sponsor>
      <public_title>Clinical &amp; antimicrobial effect of iodine potassium iodide</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of clinical and antimicrobial efficacy of 2% IKI and 2.5% sodium hypochlorite irrigants in infected root canals- An in vivo study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4421</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Chronic apical periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After first antimicrobial sampling upon access ( S1), in this group irrigation was carried out with normal saline. Two milliliters of this solution were used to irrigate the canals after each instrument (10mL overall).Each canal was flushed with 2% IKI solution as final rinse for a period of 5 minutes. After inactivation of IKI with 2mL 5% sodium thiosulfate followed by 2mL normal saline, the second microbial sampling (S2) was performed.Subsequently, the canals were filled with gutta-percha and Tubli-Seal sealer (ZOE-based; SybronEndo, Orange, CA, USA) using cold lateral compaction technique. The tooth was temporized and permanent restoration was planned at the next visit.Moreover, the patients will follow-up after 30 months to evaluate the periapical healing of the teeth by clinical and radiological examinations. Intervention 2: Positive control group: After the first antimicrobial sampling upon access (S1), in this group irrigation was performed with 2 mL 2.5% NaOCl after each instrument (10mL overall).After instrumentation was completed, the canals were flushed with 2 mL 5% sodium thiosulfate followed by 2 mL normal saline and second microbial sampling (S2) was achieved by using 3 sterile paper cones. Subsequently, the canals were filled with gutta-percha and Tubli-Seal sealer (ZOE-based; SybronEndo, Orange, CA, USA) using cold lateral compaction technique. The tooth was temporized and permanent restoration was planned at the next visit. Moreover, the patient will follow-up 30 months after treatment to monitor the healing of periapical lesion by clinical and radilogical examinations.</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>Abbas Abbaszadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghasrodasht st,Ghomabad st</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 302 8781</telephone>
        <email>dr.abbaszadegan@gmail.com</email>
        <affiliation>Faculty of Dentistry,Shiraz Universsity of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Nabavizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghasrodasht st,Ghomabad st</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 302 9846</telephone>
        <email>mohammadrezanabavizadeh@yahoo.com</email>
        <affiliation>Faculty of Dentistry,Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Only teeth with necrotic pulps as confirmed by negative response to sensitivity pulp tests were included in this study.  Patients who received antibiotic therapy within the past 3 months were excluded from the study. Teeth with extensive caries or with fractures of the root/crown and with history of previous endodontic treatment did not consider in the study. Besides, cases showing periodontal pockets over 4 mm depth were also excluded.In the second phase,presence of sinus tract, swelling, mobility, tenderness to percussion or palpation and probing depth greater than the baseline measures will be recorded by an independent investigator and will serve as exclusion criteria</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After first antimicrobial sampling upon access ( S1), in this group irrigation was carried out with normal saline. Two milliliters of this solution were used to irrigate the canals after each instrument (10mL overall).Each canal was flushed with 2% IKI solution as final rinse for a period of 5 minutes. After inactivation of IKI with 2mL 5% sodium thiosulfate followed by 2mL normal saline, the second microbial sampling (S2) was performed.Subsequently, the canals were filled with gutta-percha and Tubli-Seal sealer (ZOE-based; SybronEndo, Orange, CA, USA) using cold lateral compaction technique. The tooth was temporized and permanent restoration was planned at the next visit.Moreover, the patients will follow-up after 30 months to evaluate the periapical healing of the teeth by clinical and radiological examinations.</i_keyword>
      <i_keyword>Positive control group: After the first antimicrobial sampling upon access (S1), in this group irrigation was performed with 2 mL 2.5% NaOCl after each instrument (10mL overall).After instrumentation was completed, the canals were flushed with 2 mL 5% sodium thiosulfate followed by 2 mL normal saline and second microbial sampling (S2) was achieved by using 3 sterile paper cones. Subsequently, the canals were filled with gutta-percha and Tubli-Seal sealer (ZOE-based; SybronEndo, Orange, CA, USA) using cold lateral compaction technique. The tooth was temporized and permanent restoration was planned at the next visit. Moreover, the patient will follow-up 30 months after treatment to monitor the healing of periapical lesion by clinical and radilogical examinations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bacterial load reduction in post-treatment samples in comparison to initial samples. Timepoint: At the end of trearment session. Method of measurement: Microbial colony forming unit( CFU).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Any Change in periapical status from the baseline and presence or absence of clinical sign&amp; symptoms after 30-months. Timepoint: 30-months. Method of measurement: Clinical and radiographical evaluation of treated patient after 30-months.</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>Shiraz university of Medical Scienced</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-12-22</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>خیابان زند-ساختمان مرکزی دانشگاه علوم پزشکی شیراز Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
