<?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>IRCT20220524054979N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-16</date_registration>
      <primary_sponsor>Urmia Dental Clinic</primary_sponsor>
      <public_title>Painkiller effect of 4% Lidocaine versus 4% Articaine after wisdom teeth extraction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Articaine 4% and Lidocaine 2% for Buccal Infiltration After Inferior Alveolar Nerve Block For Intraoperative Pain Control During Impacted Mandibular Third Molar Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63861</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize, patients are divided into two groups using the blocks made by statistical software: In the first group, the surgery is conducted using Lidocaine 2%, and in the second group, the surgery is performed using Articaine 4%. All surgeries will be performed by an oral and maxillofacial surgeon and in one room with an assistant. The type of anesthesia will be selected randomly in the first surgery and will not be told to the surgeon prior to the start of injection and finishing the surgical procedure, Blinding description: Researchers examining the parameters of anesthesia success will not be aware of the type of intervention performed on the patient. Also, patients themselves will not be aware of the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Local Anesthesia administration in the mandible with Articaine 4% (SeptocaineFrance, Septodont) (with 1:100000 Epinephrine,3.6 ml, using 27 gauge needle with the speed of 1 mL/min. The needle bevel was at the bone side.  Group 1 : Inferior Alveolar nerve Block Anesthesia For Third Molar. Intervention 2: Local Anesthesia administration in the mandible with Lidocaine 2% (xylopen; Exir pharmaceutical Co, Iran) (with 1:100000 Epinephrine,3.6 ml, using 27 gauge needle with the speed of 1 mL/min. The needle bevel was at the bone side.  Group 1 : Inferior Alveolar nerve Block Anesthesia For Third Molar.</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:
No

When:
After Publication

To whom:
Patients

Conditions:
Informed Consent

Where to obtain:
Clinicians

How to obtain:
Online Access

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Hooshyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>:5714783734</zip>
        <telephone>+98 44 3336 3600</telephone>
        <email>Hooshyar.e@umsu.ac.ir</email>
        <affiliation>Urmia University of Medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Nojan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3336 3600</telephone>
        <email>farhad_nojan@yahoo.com</email>
        <affiliation>Urmia University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mandibular Third Molar Surgery Indication</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic Disease
Analgesics Consumption during last 24 hours
Allergic Reaction to Local Anesthesia Agents
Hyperalgesic Syndrome
Pregnancy and Lactating</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain, not elsewhere classified</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>Local Anesthesia administration in the mandible with Articaine 4% (SeptocaineFrance, Septodont) (with 1:100000 Epinephrine,3.6 ml, using 27 gauge needle with the speed of 1 mL/min. The needle bevel was at the bone side.  Group 1 : Inferior Alveolar nerve Block Anesthesia For Third Molar</i_keyword>
      <i_keyword>Local Anesthesia administration in the mandible with Lidocaine 2% (xylopen; Exir pharmaceutical Co, Iran) (with 1:100000 Epinephrine,3.6 ml, using 27 gauge needle with the speed of 1 mL/min. The needle bevel was at the bone side.  Group 1 : Inferior Alveolar nerve Block Anesthesia For Third Molar</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative Pain. Timepoint: 7, 4 and 21 days. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Anesthesia Duration. Timepoint: 0-12. Method of measurement: Cronometer.</prim_outcome>
      <prim_outcome>Anesthesia Start. Timepoint: 0-12. Method of measurement: Watch.</prim_outcome>
      <prim_outcome>Surgery Duration. Timepoint: 0-10. Method of measurement: Cronometer.</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>Urmia Dental Clinic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-16</approval_date>
        <contact_name>Urmia University of Medical science ethics in Biomedicine researches committee</contact_name>
        <contact_address>Alborz Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
