<?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>IRCT20201129049528N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-27</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of success of inferior alveolar nerve block in irreversible pulpitis teeth in supine and upright positions: A clinical study</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of success of inferior alveolar nerve block in irreversible pulpitis teeth in supine and upright positions: A clinical study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52668</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be selected from the qualified statistical population using simple sampling or convenient sampling method. Then, the samples will be assigned into the two intervention and control groups randomly; In so doing, 60 questionnaires will be prepared and labeled as A (30 questionnaires) and B (30 questionnaires); then, at the place of intervention, we will want the patient or his or her companion to choose one of them while he or she is blind about the type of treatment or group (blindness). Finally, we will have 30 patients in each group who are selected randomly, Blinding description: Blinding will be performed on patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Inferior alveolar nerve block.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention Group: Upright Group: In this study, there are two groups of patients who will go to Yazd dental centers for the treatment of mandibular root canal for whom the diagnosis of irreversible pulpitis has been made. In one group of anesthesia, the inferior alveolar nerve block (IAN) will be injected by upright method and in the second group, this anesthesia will be performed by supine method. The choice of injection for these two groups will be random. The injection will be done with two carpules of 2% lidocaine with epinephrine 1/80000 (Iran Pharmaceutical Company). In the upright method, dental chair headrest has a 75-degree angle with the ground and the occlusal plane of the mandibular teeth is parallel to the ground, and during this injection, the practitioner will stand. The success of IAN block will be compared to measuring the numbness of the corner of the lip within 15 minutes after injection. The presence or absence of pain during the preparation of the access cavity will also be compared. Intervention 2: Second Intervention Group: Supine Group: In this study, there are two groups of patients who will go to Yazd dental centers for the treatment of mandibular root canal for whom the diagnosis of irreversible pulpitis has been Established. In one anesthesia group, the inferior alveolar nerve block (IAN) will be injected using the upright method and in the second group, the anesthetic will be injected using the supine method. The choice of injection for these two groups will be random. The injection will be done with two carpules of 2% lidocaine with epinephrine 1/80000 (Iran Pharmaceutical Company). In the supine group, the headrest of dental chair is lowered so that the patient's foot is a bit above the head and the patient's body is parallel to the floor. The practitioner will sit during this injection. The success of IAN block will be compared to measuring the numbness of the corner of the lip within 15 minutes after injection. The presence or absence of pain during the preparation of the access cavity will also be compared.</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>Nooshin Fakhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Yazd, Iran, I. R. of</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914815698</zip>
        <telephone>+98 35 3621 3870</telephone>
        <email>Nooshin_67@ymail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nooshin Fakhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Yazd, Iran, I. R. of</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914815698</zip>
        <telephone>+98 35 3621 3870</telephone>
        <email>Nooshin_67@ymail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Spontaneous and persistent pain in only one of the molar teeth with caries so that the tooth responds to the persistent cold test
Medical Histories Class I and Class II Based on the American Society of Anesthesiology</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of allergies
Pregnant &amp; breastfeeding patients
Patients with pain in more than one tooth
Patients with a history of or suspected with any drug abuse
Patients with problems in the spine and neck
Taking any medication that interferes with a person's perception of pain
Any systemic condition that is a contraindication to inferior alveolar nerve block</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 - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention Group: Upright Group: In this study, there are two groups of patients who will go to Yazd dental centers for the treatment of mandibular root canal for whom the diagnosis of irreversible pulpitis has been made. In one group of anesthesia, the inferior alveolar nerve block (IAN) will be injected by upright method and in the second group, this anesthesia will be performed by supine method. The choice of injection for these two groups will be random. The injection will be done with two carpules of 2% lidocaine with epinephrine 1/80000 (Iran Pharmaceutical Company). In the upright method, dental chair headrest has a 75-degree angle with the ground and the occlusal plane of the mandibular teeth is parallel to the ground, and during this injection, the practitioner will stand. The success of IAN block will be compared to measuring the numbness of the corner of the lip within 15 minutes after injection. The presence or absence of pain during the preparation of the access cavity will also be compared.</i_keyword>
      <i_keyword>Second Intervention Group: Supine Group: In this study, there are two groups of patients who will go to Yazd dental centers for the treatment of mandibular root canal for whom the diagnosis of irreversible pulpitis has been Established. In one anesthesia group, the inferior alveolar nerve block (IAN) will be injected using the upright method and in the second group, the anesthetic will be injected using the supine method. The choice of injection for these two groups will be random. The injection will be done with two carpules of 2% lidocaine with epinephrine 1/80000 (Iran Pharmaceutical Company). In the supine group, the headrest of dental chair is lowered so that the patient's foot is a bit above the head and the patient's body is parallel to the floor. The practitioner will sit during this injection. The success of IAN block will be compared to measuring the numbness of the corner of the lip within 15 minutes after injection. The presence or absence of pain during the preparation of the access cavity will also be compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success of anesthesia (block). Timepoint: 15 min. Method of measurement: local anesthesia of commissure (canthus) of the lips.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-01</approval_date>
        <contact_name>Ethics Committee of Yazd Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>School of Dentistry, ُShahid Sadoughi University of Medical Scineces,  Imam Reza Sqaure, Yazd, Iran, I. R. ofe Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
