<?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>IRCT20091213002847N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-04</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>infiltration anesthetic efficacy of Articaine for mandibular canins</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of anesthetic efficacy of 1.8 milliliter Articaine and 3.6 milliliter of Articaine for infilteration anesthesia in mandibular canins with irreversible pulpitis: A randomized clinical</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70800</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 with using a sealed envelope
The even and odd numbers from 1 to 84 (even numbers for injection of  2 cartridge articaine 4% and odd numbers for injection  of 1 cartridge articaine 4%) are write on separate papers and placed in the one sealed envelope, and another dentist colleague randomly takes out a number from the envelope for each patient and performs an injection based on that, Blinding description: Before each injection, another dentist will randomly take out a piece of paper and according to the number, he will inject one of the two anesthetic volumes, so that in the first group, 1.8 milliliter of 4% Articaine solution (one anesthetic cartridge and three minutes later, the needle will be inserted into the anesthetic area without injection) and the second group, 3.6 milliliter  of 4% Articaine solution (two anesthetic cartridges three minutes apart) so that the operator and the patient are not aware of the anesthesia volume.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain during root canal treatment.</hc_freetext>
      <i_freetext>Intervention 1: 1st Intervention group: In the first group, infiltration injection of 1.8 milliliter of Articaine solution (Inibsa, Barcelona, Spain) is used. The treatment including access cavity preparation and root canal instrumentation were performed 6 minutes after the injection. Patients are taught to report any pain during each stage of preparation of the access hole and the entry of the instrument into the canal and cleaning and shaping to be recorded in the Heft-Parker visual analog pain scale (VAS) form. Intervention 2: Intervention group: : 2st Intervention group: In the second group, infiltration injection of 3.6 milliliter of Articaine solution (Inibsa, Barcelona, Spain) is used. The treatment including access cavity preparation and root canal instrumentation were performed 6 minutes after the injection. Patients are taught to report any pain during each stage of preparation of the access hole and the entry of the instrument into the canal and cleaning and shaping to be recorded in the Heft-Parker visual analog pain scale (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>Mohammad Mahdi Yaghooti Khorasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School, Shahid Mofateh Blvd.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34 3428 0031</telephone>
        <email>m_yaghooti@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mahdi Yaghooti Khorasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School, Shahid Mofateh Blvd.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34 3428 0031</telephone>
        <email>m_yaghooti@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 patients who have no systemic disease limiting dental treatment in their history
Age range from 18 to 60 years
has a mandibular canine with irreversible pulpitis and a normal periapical radiograph that not require emergency treatment.
The patient has informed consent to participate in the study</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 analgesic late 12 hours</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1st Intervention group: In the first group, infiltration injection of 1.8 milliliter of Articaine solution (Inibsa, Barcelona, Spain) is used. The treatment including access cavity preparation and root canal instrumentation were performed 6 minutes after the injection. Patients are taught to report any pain during each stage of preparation of the access hole and the entry of the instrument into the canal and cleaning and shaping to be recorded in the Heft-Parker visual analog pain scale (VAS) form.</i_keyword>
      <i_keyword>Intervention group: : 2st Intervention group: In the second group, infiltration injection of 3.6 milliliter of Articaine solution (Inibsa, Barcelona, Spain) is used. The treatment including access cavity preparation and root canal instrumentation were performed 6 minutes after the injection. Patients are taught to report any pain during each stage of preparation of the access hole and the entry of the instrument into the canal and cleaning and shaping to be recorded in the Heft-Parker visual analog pain scale (VAS) form.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain during root canal treatment. Timepoint: During access hole preparation, dentin entry, pulp chamber entry or file placement. 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>2023-03-14</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Imam Ali Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
