<?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>IRCT20110212005804N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Low level laser therapy and post endodontic pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of low level laser therapy with 980 nm diode on post endodontic pain after single-visit treatment of necrotic mandibular molars with periapical lesion; A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51018</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are placed in a randomized 4-block by the method of Balanced block. The randomization process is performed by an individual other than the investigator, and the information about the sample intervention is stored in sealed envelopes in order to randomize in excel software. The envelopes contain 18 items for the case group and 18 for the control group, Blinding description: Patient is not aware of the research treatment group allocation and process. 
Care provider (endodontist) and investigator (dental student) are aware of the research treatment group allocation and process. 
Outcome assessor, data analyser and data safety and monitoring board are not aware of the research treatment group allocation and process.</study_design>
      <phase>3</phase>
      <hc_freetext>Post treatment pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 980 nm low level laser. Intervention 2: Control group: plasbo laser.</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:
A part of the information, such as information on the main outcome, can be shared

When:
The start of the access period will be 6 to 12 months after the results are released

To whom:
Data will only be available to researchers working in academic institutions

Conditions:
Data will be available for dental research centers, universities and public and private health centers. All clinicians using laser to reduce pain after endodontic treatment are allowed to use the documentation. Dr. Mahta Fazlyab dr.mfazlyab@gmail.com +982122564571 No. 9, Faculty of Dentistry Islamic Azad University, 9th Neyestan Ave, Pasdaran Ave.

Where to obtain:
Applicants can contact the person responsible for the article to receive the information. Dr.Mahta Fazlyab dr.mfazlyab@yahoo.com Faculty of dentistry of Islamic Azad university +982122564571 No. 9, Faculty of Dentistry Islamic Azad University, 9th Neyestan Ave, Pasdaran Ave.

How to obtain:
Demand by email to the person responsible for the article Dr.Mahta Fazlyab dr.mfazlyab@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mahta Fazlyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, 9th Neyestan Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>dr.mfazlyab@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mahta Fazlyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, 9th Neyestan Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>dr.mfazlyab@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients in need for root canal treatment on mandibular molars
Mandibular molars with pulp necrosis diagnosed with vitality tests
Mandibular molars with periapical lesions scoring 2 or 3 in accordance with the periapical index classification introduced by Ørstavik et al
No pain with pulpal origin
Pain on percussion with VAS &gt; 56
Patients in good health and systemic condition determined by health history and verbal questioning</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Periodontal probing depth greater than 3 mm
Swelling or presence of sinus tract
Patients taking analgesia 12 hours prior to intervention
Teeth with open apices (immature or inflammatory root resorption)
Teeth diagnosed to be non-restorable after the endodontic treatment in primary evaluations</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Necrosis of pulp, Pulpal gangrene</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 980 nm low level laser</i_keyword>
      <i_keyword>Control group: plasbo laser</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post endodontic treatment pain. Timepoint: 4, 8, 12, 24, 48, 72 hours and day 7 after endodontic treatment and laser therapy. Method of measurement: VAS ruler.</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>None applicable</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-27</approval_date>
        <contact_name>Ethics Committee, Faculty of Dentistry, Islamic Azad University</contact_name>
        <contact_address>No. 9, Faculty of Dentistry Islamic Azad University, 9th Neyestan Ave, Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
