<?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>IRCT20210515051306N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-16</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The success rate of infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block in mandibular incisor teeth with irreversible pulpitis: A randomized clinical trial</public_title>
      <acronym>MINB,IP,PDL</acronym>
      <scientific_title>Investigating the success rate of infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block in mandibular incisor teeth with irreversible pulpitis: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>165</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization individually
3 categories (Infiltrating anesthetic injection of 1.8 ml of Articaine, injection of 1.8 ml of Articaine as mental block and injection of 1.8 ml of Lidocaine as mental block  ) were written on 165 pieces of paper and kept in sealed envelopes, Blinding description: The papers are placed in the envelope and before each injection, another dentist colleague takes them out by chance, and written injection is done by him so that the operator and patient are not aware of the type of anesthesia technique.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irreversible pulpitis of the mandibular incisor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  First intervention group: The first group of infiltrating anesthetic injection of 1.8 ml of 4% articaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form. Intervention 2: Intervention group: Second intervention group: The second group of mental nerve block is injected with 1.8 ml of 4% articaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal  preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form. Intervention 3: Intervention group: The third intervention group: The third group of mental nerve block is injected with 1.8 ml of 2% lidocaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rafsanjan University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental school, Khalij-e fars Blvd.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717931136</zip>
        <telephone>+98 34 3428 0031</telephone>
        <email>ram_aba@yahoo.com</email>
        <affiliation>Ramin Abazarpoor</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Abazarpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khalij-e fars Blvd. Dentistry Faculty</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717931136</zip>
        <telephone>+98 34 3424 2322</telephone>
        <email>abazarpoor@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy adult patients 18_60 years old
Having a mandibular incisor tooth with symptomatic irreversible pulpitis
Normal periapical radiographic appearance</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients under age of 18 and over the age of 60 years
American Society of Anesthesiologists (ASA) III,IV patients
Pregnancy or breasfeeding
Any type of medication that could potentially interact with the anesthetic solution
Spontaneous pain
Periodontal disease or unable to get restoration
Having pain killer late 12 hours
History of sensititivity to 4% articaine, 2% lidocaine or epinephrine
Widening PDL
Radiolucency in radiography
Incisor teeth sensitive to percussion
Addicted</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  First intervention group: The first group of infiltrating anesthetic injection of 1.8 ml of 4% articaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form.</i_keyword>
      <i_keyword>Intervention group: Second intervention group: The second group of mental nerve block is injected with 1.8 ml of 4% articaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal  preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form.</i_keyword>
      <i_keyword>Intervention group: The third intervention group: The third group of mental nerve block is injected with 1.8 ml of 2% lidocaine solution with 1.100000 epinephrine, using the methods mentioned in Malamed. 10 minutes after the anesthetic injection, the patient is asked about the numbness of the lower lip, and if the answer is negative, he is excluded from the study, and if the answer is positive, the tooth is isolated by a rubber band, and the caries is removed. The access hole is prepared and root canal preparation is done. Patients are taught to report any pain during each stage of the preparation of the access hole and the entry of the instrument into the canal and cleaning to be recorded in the VAS form.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score during treatment on Visual Analogue Scale (VAS). Timepoint: Before administration of the anesthetic solution and during root canal treatment. Method of measurement: Visual Analogue Scale (VAS).</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-24</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Imam Ali Blvd , Centeral Organization Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
