<?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>IRCT20190323043102N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-14</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Effect of nano silver particles on pain control between root canal therapy sessions in premolar teeth</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of intracanal drugs on calcium hydroxide blend with nano silver particles and calcium hydroxide blend and normal saline on pain relief between root canal therapy in patients with symptomatic apical periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38636</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Silver nano particles are a new material in dentistry and most of the studies on this material are about its antibacterial properties. Microorganisms are the main cause of pain between root canal treatment sessions with apical periodontitis. So we decided to design a study about the relation of the pain between root canal therapy sessions and nano silver particles, Randomization description: The patients were categorized by an assistant using random numbers table, Blinding description: number 1 was assigned to calcium hydroxide with nano silver particles , number 2 was assigned to calcium hydroxide , number 3 was assigned to sterile dry cotton pellet.
Then, on behalf of the intracanal drug type, 10 numbers of each intracanal medication were written on identical so that the numbers could not be identified. The papers were poured into a box and we asked the ward assistant to remove one sheet of paper for each patient and enter it into the file.
The patient and data analyzer were unaware of the root canal drug type and after data collection, the number assigned to each intracanal medication  was reported to the data analyzer instead of the type of intracanal medication.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Pain between root canal treatment sessions.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In patient's premolar teeth with symptomatic apical periodontitis, calcium hydroxide with silver nano particles was used as intracanal medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days. Intervention 2: Intervention group 2: In patient's premolar teeth with symptomatic apical periodontitis, calcium hydroxide with normal saline was used as intracanal medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days. Intervention 3: Control group: In patient's premolar teeth with symptomatic apical periodontitis, sterile dry cotton pellet was used as placebo medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days.</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:
Patient record, file summary, visual analogue scale (VAS) form, and 5 periapical graphs of patients are available which can be published if necessary after deleting patients' names and telephone numbers.

When:
Start of access period 6 months after printing results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Those who are researching silver nanoparticles
Comparison of pain levels between sessions in the upper and lower jaw
Comparison of pain between sessions between men and women

Where to obtain:
mmortezaei7777@gmail.com
Department of Endodontics, Faculty of Dentistry, Army University of Medical Sciences

How to obtain:
The reason for the data request should be verified by the endodontic department.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Mortezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.27 ,Etemadzade sreet, West Fatem street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>0098216-86096350</telephone>
        <email>mmortezaei7777@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Ajami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Artesh University of Medical Sciences, East Alley St., Adjouani Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>0098 21 228998983</telephone>
        <email>dr_ajami2@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient seeking root canal treatment
closed apex</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic disease
tooth with internal or external resorption
Use of antibiotics and analgesics before treatment
pregnancy
Non-repairable teeth
A history of chronic use of analgesics, narcotic or alcohol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute apical periodontitis of pulpal origin</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In patient's premolar teeth with symptomatic apical periodontitis, calcium hydroxide with silver nano particles was used as intracanal medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days.</i_keyword>
      <i_keyword>Intervention group 2: In patient's premolar teeth with symptomatic apical periodontitis, calcium hydroxide with normal saline was used as intracanal medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days.</i_keyword>
      <i_keyword>Control group: In patient's premolar teeth with symptomatic apical periodontitis, sterile dry cotton pellet was used as placebo medication one time between root canal therapy sessions at the end of the first treatment session after cleaning and shaping of root canal system for 4 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-treatment pain above 3. Timepoint: between two root canal sessions at 6, 12 , 24 and 48 hours after first session (2 session root canal with intracanal medication ). Method of measurement: Visual analog scale (VAS): patients are asked to mark the pain level at 6, 12 , 24 and 48 hours after first session of their treatment then the 10 cm line of each period was measured from left(no pain) in millimeter.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-28</approval_date>
        <contact_name>Ethics Committee of AJA University of Medical Sciences</contact_name>
        <contact_address>AJA University of Medical Sciences, Etemadzade avenue., West Fatemi boulevard, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
