<?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>IRCT2012110510866N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-11-05</date_registration>
      <primary_sponsor>Azad University of Khorasgan-ُSchool of Dentistry-</primary_sponsor>
      <public_title>X-tip intraosseous injection system as a primary anesthesia for irreversible pulpitis of posterior mandibular teeth</public_title>
      <acronym></acronym>
      <scientific_title>X-tip intraosseous injection system as a primary anesthesia for irreversible pulpitis of posterior mandibular teeth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11285</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Successful anesthesia during root canal therapy may be difficult to obtain. Intraosseous injection significantly improves anesthesia's success as a supplemental pulpal anesthesia, particularly in cases of irreversible pulpitis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irreversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: A single clinician performed all procedures, including diagnosis, injection, and anesthesia evaluation.  For the first group, the X-tip intraosseous injection was done according to the manufacturer’s instructions; after evaluating root proximity by radiography, perforation site was located in alveolar mucosa at the distal site of the first molars or at the mesial site of the second molars. A volume of (0.1 ml) 2% lidocaine with 1:100,000 epinephrine (Darou pakhsh, Tehran, Iran) was infiltrated through a 30 gauge needle at the perforation site before intraosseous injection. The perforator drill position was 90-degree angle to the cortical bone and the slow-speed hand piece was activated in a series of short bursts, using light pressure until 2 to 5 seconds had passed. The needle was then engaged in a pen-gripping fashion and 1.8 ml of 2% lidocaine with 1:100,000 epinephrine was injected slowly during 60 seconds. Before inserting the 27 gauge ultrashort X-tip needle into the guide sleeve, the needle was bent with a 60 to 80 degree angle to allow the easy insertion. The perforator was pushed through the alveolar mucosa until the X-tip faced bone. Intervention 2: One healthy Contralateral tooth in the same jaw served as negative control and received no anesthesia and was tested by endo Ice and electric pulp tester. A single clinician performed all procedures, including diagnosis, injection, and anesthesia evaluation. In the second group, the IAN block was performed by standard technique. The IAN block group received the same type and volume of anesthetic solution.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Maryam Zare Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Endodontics, Islamic Azad University of Medical Sciences, Khorasgan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1792 2869</telephone>
        <email>jahromi@yahoo.com</email>
        <affiliation>Department of Endodontics, Islamic Azad University of Medical Sciences, Khorasgan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hamid Razavian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 910 300 1269</telephone>
        <email>hamid.razavian@yahoo.com</email>
        <affiliation>School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>no remarkable systemic disease e.g. cardiovascular disease, no history of taking any analgesic drugs during the past 24 hours that would alter the inflammatory response of the pulp, one mandibular posterior tooth with irreversible pulpitis.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of pulp and periapical tissues</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A single clinician performed all procedures, including diagnosis, injection, and anesthesia evaluation.  For the first group, the X-tip intraosseous injection was done according to the manufacturer’s instructions; after evaluating root proximity by radiography, perforation site was located in alveolar mucosa at the distal site of the first molars or at the mesial site of the second molars. A volume of (0.1 ml) 2% lidocaine with 1:100,000 epinephrine (Darou pakhsh, Tehran, Iran) was infiltrated through a 30 gauge needle at the perforation site before intraosseous injection. The perforator drill position was 90-degree angle to the cortical bone and the slow-speed hand piece was activated in a series of short bursts, using light pressure until 2 to 5 seconds had passed. The needle was then engaged in a pen-gripping fashion and 1.8 ml of 2% lidocaine with 1:100,000 epinephrine was injected slowly during 60 seconds. Before inserting the 27 gauge ultrashort X-tip needle into the guide sleeve, the needle was bent with a 60 to 80 degree angle to allow the easy insertion. The perforator was pushed through the alveolar mucosa until the X-tip faced bone.</i_keyword>
      <i_keyword>One healthy Contralateral tooth in the same jaw served as negative control and received no anesthesia and was tested by endo Ice and electric pulp tester. A single clinician performed all procedures, including diagnosis, injection, and anesthesia evaluation. In the second group, the IAN block was performed by standard technique. The IAN block group received the same type and volume of anesthetic solution.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anesthesia. Timepoint: 5 min. Method of measurement: response to the cold testing and the electric pulp tester for two sequential intervals was the definitive criterion for successful anesthesia.</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>Azad University of Khorasgan-ُSchool of Dentistry-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Dental Research Committee of Islamic Azad University of Medical Sciences,</contact_name>
        <contact_address>Islamic Azad University of Medical Sciences,  Khorasgan, Isfahan Khorasgan, Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
