<?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>IRCT20101108005141N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-03</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>the success of inferior alveolar nerve block with intraligament or buccal infiltration in mandibular posterior teeth</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the success of inferior alveolar nerve block with intraligament or buccal infiltration in mandibular first molar with symptomatic irriversible pulpitis : A randomized control clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5487</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: We will have 32 patients in each group (16 women and 16 men) who will be randomly assigned into three groups. The randomization unit is individual. A randomization tool will be performed with the Randlist software (each patient entering the study will be assigned a number from 1 to 48 (for male and female) as a code and sorted according to the numbers and the software will be randomized into three groups. The person who randomizes is not aware of how to study, Blinding description: 1. The groups will be coded to the statistical analyzer and the analyst is not aware of the type of technique.

2. Anesthetizing by one person and providing an access cavity and recording pain will be done by another person. The pain recorder is not aware of the study technique.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pulp disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the control group, standard block injection was performed using Articanin 4% solution (Artinibsa; Inibsa, Barcelona, Spain) with epinephrine 100000/1. After 15 minutes, the anesthetized teeth were isolated and the cavity was prepared and access prepration will be done. Intervention 2: Intervention group 1: Block standard injection is performed using Articaine 4% solution (Artinibsa; Inibsa, Barcelona, Spain) with an epinephrine of 100,000/1. After 15 minutes of block anesthesia and numbness of the lips, an infiltration on the buccal side of the affected tooth will be performed at a rate of 0.5 ml with a normal syringe with 27 gauge needle.After 5 minutes, the teeth will be isolated and the access cavity will be done. Intervention 3: Intervention group 2: After IANB injection and 15 minute timeout and anesthesia of the lips, intra-ligament injection with a special injection syringe and a short needle with 27 gauge will be done.Then, in the mesial and distal teeth, 0.2 ml of the solution is injected and after 5 minutes the access cavity is prepared.</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 not more data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr shahriar shahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor3, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>sshahriar32@gmail.com</email>
        <affiliation>Periodontal and dental research center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr shahriar shahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor3, Central Building No2, Tabriz University of Medical Sciences, Golgasht St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>sshahriar32@gmail.com</email>
        <affiliation>Faculty of dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Systemically healthy patient
Subjects 18-65 years of age
No sensivity to epinephrin and articaine
No facial parastacidae
Do not use any medication 6 hours before treatment
Not taking any medication that interferes with numbness
No pathoes in the areas of injection
Patient not to be pregnant
Absence of pathologic pockets during probing
The patient with the first molar with symptomatic irriversible pulpitis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any illness that is unable to fill the informed consent form
history of trauma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ICD-XI</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the control group, standard block injection was performed using Articanin 4% solution (Artinibsa; Inibsa, Barcelona, Spain) with epinephrine 100000/1. After 15 minutes, the anesthetized teeth were isolated and the cavity was prepared and access prepration will be done.</i_keyword>
      <i_keyword>Intervention group 1: Block standard injection is performed using Articaine 4% solution (Artinibsa; Inibsa, Barcelona, Spain) with an epinephrine of 100,000/1. After 15 minutes of block anesthesia and numbness of the lips, an infiltration on the buccal side of the affected tooth will be performed at a rate of 0.5 ml with a normal syringe with 27 gauge needle.After 5 minutes, the teeth will be isolated and the access cavity will be done.</i_keyword>
      <i_keyword>Intervention group 2: After IANB injection and 15 minute timeout and anesthesia of the lips, intra-ligament injection with a special injection syringe and a short needle with 27 gauge will be done.Then, in the mesial and distal teeth, 0.2 ml of the solution is injected and after 5 minutes the access cavity is prepared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of pain. Timepoint: during access cavity preparation and entrance in to the pulp chamber and  the root canal. Method of measurement: Use Visual Analogue Scale.</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>Vice chancellor for research, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-27</approval_date>
        <contact_name>Ethics committee tabriz university of medical science</contact_name>
        <contact_address>Floor3- Centeral Building No2-Tabriz University of Medical Sciences- Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
