<?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>IRCT20210515051306N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-07</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>anesthetic efficacy of 1.8 mL articaine, 1.8 mL and 3.6 mL of lidocaine for mental nerve block in irreversible pulpitis of the mandibular premolar</public_title>
      <acronym>MINB</acronym>
      <scientific_title>Comparative evaluation of anesthetic efficacy of 1.8 mL articaine, 1.8 mL and 3.6 mL of lidocaine for mental nerve block in mandibular premolar with irreversible pulpitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>165</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57211</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomizzation individually
3 categories (1.8 lidocaine, 1.8 articaine and 3.6 lidocaine) were written on 165 pieces of paper and kept in sealed envelopes, Blinding description: The first practitioner who perform the local anesthetic injection will open the envelope, and based on the category each patient will receive either 2 cartridges of the anesthetic solution or a cartridge of the anesthetic solution followed by a mock injection. Another practitioner will perform the rest of the treatment including access cavity preparation and root canal instrumentation. Hence, the second practitioner and the patients won't be aware of the volume of anesthetic solution used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>irreversible pulpitis of the mandibular premolar.</hc_freetext>
      <i_freetext>Intervention 1: 1st Intervention group: The mental nerve block involved adeposition of 1.8 mL 2% lidocaine with1:80,000 epinephrine (Xilonibsa, Inibsa, Barcelona, Spain) each patient received 2 cartridges of the anesthetic solution.  the treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment. Intervention 2: 2nd Intervention group: The mental nerve block involved a deposition of 1.8 mL 4% articaine with1:100,000 epinephrine (Artinibsa, Inibsa, Barcelona, Spain) each patient received a cartridge of the anesthetic solution followed by a mock injection. The treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment. Intervention 3: 3rd Intervention group: The mental nerve block involved adeposition of 1.8 mL 2% lidocaine with1:80,000 epinephrine (Xilonibsa, Inibsa, Barcelona, Spain) each patient received a cartridge of the anesthetic solution followed by a mock injection. The treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment.</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>Ramin Abazarpoor</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>Rafsanjan University of Medical Sciences</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 premolar tooth with symptomatic irreversible pulpitis
Normal periapical radiographic appearance</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of sensitivity to 4%articaine or epinephrine
Systemic diseases
Pregnancy or breastfeeding
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</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>1st Intervention group: The mental nerve block involved adeposition of 1.8 mL 2% lidocaine with1:80,000 epinephrine (Xilonibsa, Inibsa, Barcelona, Spain) each patient received 2 cartridges of the anesthetic solution.  the treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment.</i_keyword>
      <i_keyword>2nd Intervention group: The mental nerve block involved a deposition of 1.8 mL 4% articaine with1:100,000 epinephrine (Artinibsa, Inibsa, Barcelona, Spain) each patient received a cartridge of the anesthetic solution followed by a mock injection. The treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment.</i_keyword>
      <i_keyword>3rd Intervention group: The mental nerve block involved adeposition of 1.8 mL 2% lidocaine with1:80,000 epinephrine (Xilonibsa, Inibsa, Barcelona, Spain) each patient received a cartridge of the anesthetic solution followed by a mock injection. The treatment including access cavity preparation and root canal instrumentation were performed 2-3 minutes after the injection. The patients were asked to rate their pain using a Heft-Parkervisual analog pain scale (VAS) before administration of the anesthetic solution and during the endodontic treatment.</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 the endodontic 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>2021-06-22</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Imam Ali Blv. Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
