<?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>IRCT20200705048014N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-21</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the effect of local anesthesia with epinephrine on blood pressure of people applying for tooth extraction</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the effect of local anesthesia with epinephrine (with Inferior Alveolar Nerve Block anesthesia technique) on blood pressure of people applying for tooth extraction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49443</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stochasticization process In this study, quadruple blocks are randomly divided into two groups. One group receiving anesthesia containing epinephrine and one group receiving anesthesia without epinephrine.
Randomization is done in individual units using STATA software and Block Randomization method, Blinding description: The patient is not informed of the medication to be taken and the anesthetic carpole is placed in the injection syringe before the patient is present and the evaluator is not aware of the type of anesthetic injection.</study_design>
      <phase>3</phase>
      <hc_freetext>Blood-pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group were injected with two carpools of lidocaine containing 108 mg of lidocaine and 0.054 mg of epinephrine for local anesthesia. Intervention 2: Control group: Patients in this group are injected with two carpooles of Citanest containing 162 mg of Citanest for local anesthesia.</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:
The information from this study can be shared without identifying participants.

When:
2021/3/21

To whom:
Researchers and referees

Conditions:
Obtaining a written permit and mentioning the name in the sources and references

Where to obtain:
Dr. Mohammad Reza Moaddeli
m.moaddeli@hums.ac.ir

How to obtain:
The request must first be emailed and answered after review and approval.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Moaddeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Blvd.</address>
        <city>Badar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3335 0458</telephone>
        <email>m.moaddeli@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Moaddeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Blvd.</address>
        <city>Badar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3335 0458</telephone>
        <email>m.moaddeli@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have referred for tooth extraction and use Inferior Alveolar Nerve Block anesthesia for anesthesia
Patients who have no systemic problems and are in good general health.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who do not want to cooperate.
Patients with cardiovascular problems.
Patients with uncontrolled blood pressure.
Patients with uncontrolled hyperthyroidism.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R03.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Elevated blood-pressure reading, without diagnosis of hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in this group were injected with two carpools of lidocaine containing 108 mg of lidocaine and 0.054 mg of epinephrine for local anesthesia.</i_keyword>
      <i_keyword>Control group: Patients in this group are injected with two carpooles of Citanest containing 162 mg of Citanest for local anesthesia.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Systolic blood pressure is measured in four stages. 1- Five minutes before the anesthetic injection. 2- Immediately after anesthesia injection. 3- Immediately after the tooth  is removed. 4- Five minutes after the tooth is removed. Method of measurement: Systolic blood pressure is measured in each patient at all four stages by a dentist who does not know the type of anesthesia using a calibrated EmSig sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Diastolic blood pressure is measured in four stages. 1- Five minutes before the anesthetic injection. 2- Immediately after anesthesia injection. 3- Immediately after the tooth  is removed. 4- Five minutes after the tooth is removed. Method of measurement: Diastolic blood pressure is measured in each patient at all four stages by a dentist who does not know the type of anesthesia using a calibrated EmSig sphygmomanometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Heart rate is measured in four stages. 1- Five minutes before the anesthetic injection. 2- Immediately after anesthesia injection. 3- Immediately after the tooth  is removed. 4- Five minutes after the tooth is removed. Method of measurement: Heart rate is measured in each patient at all four stages by a dentist who does not know the type of anesthesia using an EmSig stethoscope.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-14</approval_date>
        <contact_name>Ethics Committee of Bandar Abbas University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Bandar Abbas University of Medical Sciences,Research Deputy Building, Shahid Mohammadi Hospital, Jomhoori Islami Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
