<?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>IRCT20220117053751N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-30</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Anesthesia Efficiency of Local Infiltration with Articaine 4% and Mental Nerve Block with Lidocaine 2% in Extraction of Mandibular Anterior Teeth</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Anesthesia Efficiency of Local Infiltration with Articaine 4% and Mental Nerve Block with Lidocaine 2% in Extraction of Mandibular Anterior Teeth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61515</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups of 27 based on limited randomization and using the law of random allocation. Randomization based on a single sequence of random allocations is called simple or unlimited randomization. Simple randomization is one of the most common methods used to perform the randomization process. In this method, there is a possibility of inequality in the number of people assigned to each group, especially in studies with a small sample size. While according to the probability hypothesis, with increasing the sample size, this inequality will be greatly reduced and the division will be based on the coin toss, Blinding description: Researchers will be blind to the process of randomization and sample allocation. The patient's pain will be assessed by a second person who will be on the blind injection.</study_design>
      <phase>3</phase>
      <hc_freetext>compare anesthesia drugs.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Anesthetic recipient Local infiltration with 4% articaine with lingual infiltration, standard injection with 25 gauge needle with short length will be done slowly (1 minute) by a surgeon in the same conditions. After the needle is inserted. And negative blood aspiration, 1.5 ml of 4% articaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) for buccal infiltration and 0.3 ml (about one-eighth of the cartridge) for lingual infiltration will be injected. Intervention 2: Intervention group 2: After needle insertion and negative blood aspiration, 1.5 ml of 2% lidocaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) by mental nerve block method and 0.3 ml (about one-eighth of the cartridge) Will also be injected for lingual infiltration.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Soltanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz street,alborz dental clinic</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2345674345</zip>
        <telephone>+98 44 3336 3600</telephone>
        <email>amirsoltanpour76@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Soltanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz street,alborz dental clinic</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2345674345</zip>
        <telephone>+98 44 3336 3600</telephone>
        <email>amirsoltanpour76@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with age range of 18-45
At least one mandibular anterior tooth
No systemic problems
No allergies to anesthetic solutions used
Absence of inflammation and soft tissue infection near the injection site
Do not take painkillers 24 hours before treatment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>systemic problems like diabet
allergies to anesthetic solutions used
inflammation and soft tissue infection near the injection site
take painkillers 24 hours before treatment</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 - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Anesthetic recipient Local infiltration with 4% articaine with lingual infiltration, standard injection with 25 gauge needle with short length will be done slowly (1 minute) by a surgeon in the same conditions. After the needle is inserted. And negative blood aspiration, 1.5 ml of 4% articaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) for buccal infiltration and 0.3 ml (about one-eighth of the cartridge) for lingual infiltration will be injected.</i_keyword>
      <i_keyword>Intervention group 2: After needle insertion and negative blood aspiration, 1.5 ml of 2% lidocaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) by mental nerve block method and 0.3 ml (about one-eighth of the cartridge) Will also be injected for lingual infiltration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: during tooth extraction. Method of measurement: The SEM scale will be used to measure the patient's pain during treatment, which is a ranking variable. The SEM scale for measuring pain is a valid, useful and easy-to-use scale that is used in various researches. This scale includes recording of the patient's voice (Sound), examination of the eyes (Eyes) and patient movements (Motor), which will be recorded separately for each treatment, after the injection.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-09</approval_date>
        <contact_name>Ethics committee of urmia University of Medical Sciences</contact_name>
        <contact_address>Orjans ave,urmia University of Medical Sciences urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
