<?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>IRCT20221015056184N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-27</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>A comparison of two anesthetic methods: IAN block technique vs local infiltration technique</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of two anesthetic methods with 2% lidocaine for the surgical removal of impacted mandibular third molars: IAN block technique vs local infiltration technique</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66312</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, randomization will be done according to the random allocation rule. In this way, before the start of the study, people will be divided into two equal groups. The procedure will be that the numbers one to thirty written on paper are poured into a container and fifteen papers are removed. These fifteen selected numbers will form the members of the first group and the rest of the numbers will form the members of the second group. The first group will receive an infiltration injection in the first session and the second group will receive a block injection in the first session, Blinding description: The volume of anesthetic injected on both sides is the same for each person. The anesthesia injection method is not discussed with the patient and the evaluating researcher until the end of the surgery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anesthesia effect of lidocaine solution in two methods: block and infiltration, in the posterior mandible.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In all the studied subjects, for the extraction of the wisdom teeth on one side of the lower jaw, anesthesia injection will perform by infiltration method. The solution to be used will be two carpules Lidocaine 2% with epinephrine 1 in 80000 manufactured by Loqman Company. Intervention 2: Control group: In all the studied subjects, for the extraction of the wisdom teeth that are hidden on one side of the lower jaw, anesthesia injection will perform by direct block (Halsted) method. The solution to be used will be two carpules Lidocaine 2% with epinephrine 1 in 80000 manufactured by Loqman Company.</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:
sex, age, anesthesia method, pain during injection, latency of anesthesia onset on surgical field, mental and lower lip, pain during surgery

When:
Access available 6 months after publication

To whom:
dental students and dentists

Conditions:
The use of data is only allowed to know the research process and the accuracy of the content, and it is not allowed to use them for use in another study.

Where to obtain:
Applicants should contact the following email address to receive data: mehdisaberishakib@gmail.com

How to obtain:
It will be possible to receive the data after the request through e-mail and authentication by providing the student number or pratitioner number

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Saberi Shakib</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 57, Vesal Shirazi Ave., Enghelab Eslami Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416863131</zip>
        <telephone>+98 21 6649 5118</telephone>
        <email>mehdisaberishakib@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Saberi Shakib</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 57, Vesal Shirazi Ave., Enghelab Eslami Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416863131</zip>
        <telephone>+98 21 6649 5118</telephone>
        <email>mehdisaberishakib@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with symmetrical fully impacted lower third molars</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients with systemic disorders
drug consuming patients
patients taking antianxiety drugs
patients with active infection in the wisdom tooth area</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K01.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impacted teeth</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 group: In all the studied subjects, for the extraction of the wisdom teeth on one side of the lower jaw, anesthesia injection will perform by infiltration method. The solution to be used will be two carpules Lidocaine 2% with epinephrine 1 in 80000 manufactured by Loqman Company.</i_keyword>
      <i_keyword>Control group: In all the studied subjects, for the extraction of the wisdom teeth that are hidden on one side of the lower jaw, anesthesia injection will perform by direct block (Halsted) method. The solution to be used will be two carpules Lidocaine 2% with epinephrine 1 in 80000 manufactured by Loqman Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain during anesthesia injection with infiltration method. Timepoint: Immediately after injection. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pain during injection of anesthesia with block method. Timepoint: Immediately after injection. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pain during surgery in infiltration anesthesia group. Timepoint: Immediately after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pain during surgery in block anesthesia group. Timepoint: Immediately after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The delay in the onset of anesthesia in the surgical area, mental area, and lower lip in the infiltration anesthesia method. Timepoint: One-minute intervals after anesthesia injection until the patient feels no pain. Method of measurement: Record the tissue numbing time after the injection.</prim_outcome>
      <prim_outcome>The delay in the onset of anesthesia in the surgical area, mental area, and lower lip in the block anesthesia method. Timepoint: One-minute intervals after anesthesia injection until the patient feels no pain. Method of measurement: Record the tissue numbing time 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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-21</approval_date>
        <contact_name>Research Ethics Committees of shahed university</contact_name>
        <contact_address>Floor 13, Block A The central headquarters of the Ministry of Health, Medical Treatment and Education,Simaye Iran Ave., Qods Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
