<?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>IRCT20250923067345N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation of the Effect of Low-Level Laser Therapy on Reducing Pain After Root Canal Treatment</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and Comparison of the Effects of Low-Level Laser Therapy at 810 nm and 660 nm in Reducing Postoperative Pain Following Root Canal Treatment of Maxillary and Mandibular Premolars and Molars with Irreversible Pulpitis Accompanied by Apical Periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In our study, the effect of two different laser wavelengths on postoperative pain after root canal treatment are evaluated, and no control group is included, Blinding description: Patients: In our study, patients are unaware of which type of laser they receive (810 nm or 660 nm).
Data Analyst: The statistician does not know which group received which wavelength and only evaluates the pain levels at different time intervals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postoperative pain after root canal treatment in posterior teeth with irreversible pulpitis accompanied by symptomatic apical periodontitis in the maxilla and mandible..</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Laser irradiation at a wavelength of 660 nm with a power of 100 W and an energy of 4 J for 40 seconds over an area of 1 cm² at the apex of the treated tooth, applied to both the buccal and lingual/palatal surfaces. Intervention 2: Intervention Group 2: Laser irradiation at a wavelength of 810 nm with a power of 100 W and an energy of 4 J for 40 seconds over an area of 1 cm² at the apex of the endodontically treated tooth, applied to both the buccal and lingual/palatal surfaces.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information is available. I have no objection to the publication of the data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anahita Alikhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21, Esfand Ave., Mehr Ave., Bahar Ave., Farabi 4th Blvd., Sepahan Shahr, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8137999594</zip>
        <telephone>+98 933 197 3330</telephone>
        <email>Anahitaalkh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anahita Alikhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21, Esfand Ave., Mehr Ave., Bahar Ave., Farabi 4th Blvd., Sepahan Shahr, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8137999594</zip>
        <telephone>+98 933 197 3330</telephone>
        <email>anahitaalkh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with irreversible pulpitis accompanied by symptomatic apical periodontitis in mandibular and maxillary premolars and molars, eligible for single-visit root canal treatment.
No use of analgesics within 48 hours prior to treatment.
Based on the Heft-Parker (HPS) scale, patients with a pre-treatment VAS score above 54 are included in the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic diseases
Pregnant or breastfeeding women
Treatment of calcified teeth
Patients seeking secondary or retreatment procedures
Patients currently taking anti-inflammatory medications</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Laser irradiation at a wavelength of 660 nm with a power of 100 W and an energy of 4 J for 40 seconds over an area of 1 cm² at the apex of the treated tooth, applied to both the buccal and lingual/palatal surfaces.</i_keyword>
      <i_keyword>Intervention Group 2: Laser irradiation at a wavelength of 810 nm with a power of 100 W and an energy of 4 J for 40 seconds over an area of 1 cm² at the apex of the endodontically treated tooth, applied to both the buccal and lingual/palatal surfaces.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative Pain. Timepoint: 4, 8, 12, and 24 hours after laser irradiation. Method of measurement: Pain intensity will be measured using the Heft-Parker Visual Analog Scale (VAS, HPS).</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 of Isfahan (Khorasgan)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-20</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Isfahan (Khorasgan) Branch.</contact_name>
        <contact_address>No. 21, Esfand Ave., Mehr Ave., Bahar Ave., Farabi 4th Blvd., Sepahan Shahr, Isfahan. Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
