<?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>IRCT20260122068639N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-16</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>anesthesia in root canal retreatment</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between anesthetic efficacy of articaine and lidocaine secondary endodontic treatment in mandibular molar teeth : A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88751</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups, Group A and Group B: Lidocaine VS Articaine (Men) and Lidocaine VS Articaine (Women), using the website www.SealedEnvelope.com. Each patient, after entering the study, will determine their group by selecting the word "Randomization", Blinding description: The anesthetic injection is performed by two endodontic specialty residents (other than the main operator) who have rehearsed and calibrated the block and infiltration injection techniques in a separate session.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Root canal retreatment of mandibular molars.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Use of supplementary infiltration injection of Articaine after mandibular block injection with Lidocaine in root canal retreatment of manibular molars. Intervention 2: Control group: Use of mandibular block injection with Lidocaine in root canal retreatment of manibular molars.</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 portion of the data, such as information related to the main message or similar items, can be shared

When:
The access period begins one year after the results are published

To whom:
It will only be available to researchers employed at academic and scientific institutions

Conditions:
Use of the information is permitted solely for scientific purposes

Where to obtain:
Email address: m.moradinia.g@gmail.com

How to obtain:
By sending an email to the mentioned address, the documentation will reach them after one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Manouchehrifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa street . Kerman university of medical sciences</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 914 315 4323</telephone>
        <email>hamed_man61@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Manouchehrifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa street . Kerman university of medical sciences</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 914 315 4323</telephone>
        <email>hamed_man61@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>– First or second mandibular molars with a history of root canal treatment having a Periapical Index (PAI) score of 1, 2, or 3.
Teeth previously treated with root canal therapy but unsuccessful and having developed apical periodontitis (AP).
Individuals with a spontaneous pain score of less than 54 mm on the HP-VAS scale
Teeth with radiographically poor-quality root canal fillings.
Teeth with failed or insufficient coronal restoration requiring root canal retreatment.
Patients aged 18 to 65 years
Patients with ASA I and ASA II
Patients without acute pain or extracoral swelling
Patients with acute apical abscess
Patients who voluntarily participate in the study and are available for follow-up
Absence of severe periodontal problem in the tooth in question
Teeth with prefabricated posts</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals with a spontaneous pain score greater than 54 on the HP-VAS scale
Patients whose retreatment requires two sessions.–
Teeth with internal or external root resorption
Teeth with vertical root fracture or dental crack
Teeth with open or immature apex
Patients with systemic diseases (such as bone metabolism disorders)
Patients taking medications affecting bone metabolism
Patients with acute pain who have taken analgesics in the past 24 hours
Patients who did not attend follow-up sessions
third molars
Presence of severe periodontal disease rendering the tooth unsuitable for endodontic treatment
Periodontal probing depth greater than 3 mm.
Root canal treatment extending beyond the canal length and over instrumentation
Teeth with cast posts or broken files inside the canal
Patients with contraindications to NSAIDs
Patients who experience treatment errors during retreatment
Patients who are accidentally over-instrumented during the procedure
Patients in whom post-operative radiography shows any extrusion of the root canal filling material
Teeth with extensive caries making restoration impossible</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified diseases of pulp and periapical tissues</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: Use of supplementary infiltration injection of Articaine after mandibular block injection with Lidocaine in root canal retreatment of manibular molars</i_keyword>
      <i_keyword>Control group: Use of mandibular block injection with Lidocaine in root canal retreatment of manibular molars</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in the Heft-Parker Visual Analog Scale (HP-VAS) questionnaire. Timepoint: Before the start of treatmentDuring the injectionDuring removal of the coronal restorationDuring removal of gutta-percha from the canalsDuring canal preparation and irrigationDuring obturationImmediately after completion of the procedure,6 hours after the procedure,12 hours after the procedure, 24 hours after the procedure, 2 days after the procedure, 3 days after the procedure،7 days after the procedure. Method of measurement: Heft-Parker Visual Analog Scale (HP-VAS) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: Before the start of treatment, 7 days after treatment. Method of measurement: Oral Health Impact Profile-14 (OHIP-14) questionnaire.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-11-02</approval_date>
        <contact_name>Kerman University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Kerman, Jomhori Esalmi Blvd, Shafa Street Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
