<?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>IRCT20131216015814N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-21</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of premedication on tooth anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of premedication with ibuprofen on the success of lower alveolar nerve block with lidocaine in comparison with infiltration of articaine in symptomatic irreversible pulpitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14972</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: From patients with symptomatic irreversible pulpitis referring to the Department of Endodontics, Faculty of Dentistry Qazvin, 88 patients will be randomly selected on the basis of win pepi software, Blinding description: None of the patients, the practitioner, and the statistician are aware of the contents of the capsules, and only the manufacturer of the drug is aware of the contents of the capsules.
 All capsules containing the drug or placebo have the same shape and color and size and have their own code. In
Group 1 and 2 placebo capsules, and in groups 3 and 4, ibuprofen 400 mg capsules are given to the patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Irreversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:Premedication with ibuprofen (400 mg) 30 minutes before anesthesia and infiltration of articaine 4% + epinephrine 1.100000. Intervention 2: Intervention 2: Premedication with placebo 30 minutes before anesthesia and infiltration of articaine 4% + epinephrine 1.100000. Intervention 3: Intervention group: Intervention 3: Premedication with ibuprofen (400 mg) 30 minutes before anesthesia and IANB anesthesia with lidocaine 2% + epinephrine 1.100000. Intervention 4: Intervention 4: Premedication with placebo 30 minutes before anesthesia and IANB anesthesia with lidocaine 2% + epinephrine 1.100000.</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:
All the information of the participants

When:
Up to one year after the publication of the results

To whom:
Free access to data for all people

Conditions:
Data will be available for designing further studies and meta-analyzes

Where to obtain:
To communicate with Ramezani masoumeh
 Mobile number:09129490407
Email:M269_ramezani@yahoo.com

How to obtain:
Up to 2 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahrzad Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Endodontic department,  Dental School,  University of Medical sciences,  Bahonar Blvd.,Qazvin Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3414685537</zip>
        <telephone>+98 28 3335 3061</telephone>
        <email>Jalali.shahrzad@gmail.com</email>
        <affiliation>Qazvin Dental School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrzad Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Endodontic department,  Dental School,  Qazvin University of Medical Sciences, Bahonar Blvd.Qazvin town,</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415759811</zip>
        <telephone>+98 28 3335 3061</telephone>
        <email>Jalali.shahrzad@gmail.com</email>
        <affiliation>Qazvin dental school</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with first or second mandibular molars requiring root canal treatment with the diagnosis of symptomatic irreversible pulpitis and a history of spontaneous pain.
Patients who are completely healthy or have a mild systemic disease that is well controlled (ASA I, II)
Patients who have the ability to fill out a questionnaire and a consent letter
Patients over 18 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with heart pacemakers
Asthma, coagulation disorders, immune deficiency, diabetes, hypertension, mental disorders
pregnancy
Sensitivity or contraindication for receiving lidocaine, articaine, epinephrine and  NSAIDs
The presence of open apex or calcification in the root of the Intended tooth
The  presence of extensive  restoration or periodontal disease
use of analgesic drugs 12 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 - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1:Premedication with ibuprofen (400 mg) 30 minutes before anesthesia and infiltration of articaine 4% + epinephrine 1.100000</i_keyword>
      <i_keyword>Intervention 2: Premedication with placebo 30 minutes before anesthesia and infiltration of articaine 4% + epinephrine 1.100000</i_keyword>
      <i_keyword>Intervention group: Intervention 3: Premedication with ibuprofen (400 mg) 30 minutes before anesthesia and IANB anesthesia with lidocaine 2% + epinephrine 1.100000</i_keyword>
      <i_keyword>Intervention 4: Premedication with placebo 30 minutes before anesthesia and IANB anesthesia with lidocaine 2% + epinephrine 1.100000</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain during cavity preparation. Timepoint: Fifteen minutes after injection. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Need for complementary injection. Timepoint: Fifteen minutes after block injection. Method of measurement: Complementary anesthetizing.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Faculty of Dentistry Qazvin,Shahid Bahonar Blvd., Qazvin Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
