<?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>IRCT20101108005141N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-04</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The success rate of  different anesthesia protocols  in mandibular posterior teeth</public_title>
      <acronym>IANB</acronym>
      <scientific_title>Comparison  of the success rate of different anesthesia protocols  in mandibular first molars with symptomatic irreversible pulpitis using prilocain local anesthesia : 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>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5488</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 four 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 64 (for male and female) as a code and according to the arrenged numbers in the software will be randomized into four groups. The person who randomizes wont be aware of how to study, Blinding description: 1. The groups will be coded and presented to the statistical analyzer and the analyst wont be aware of the type of technique.

2. Anesthetizing will be done by one person and providing an access cavity and recording pain will be done by another person. The pain recorder wont be aware of the study technique.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Symptomatic irreversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:IANB(Inferior alveolar nerve block) standard injection  using prilocaine 3%  solution (Prilocaine,  Felypressin 0.03 IU/Darou Pakhsh,Iran ) will be done . 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 2: 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 will be injected and after 5 minutes the access cavity will be prepared. Intervention 3: Intervention group 3:After IANB injection and 15 minute timeout and anesthesia of the lips, second IANB injection will be done.and after 5 minutes the access cavity will be prepared. Intervention 4: Control group:In the control group, standard block injection using Prilocaine 3% solution (Prilocaine,  Felypressin 0.03 IU/Darou Pakhsh,Iran) will be done . After 15 minutes and anesthesia of the lips, teeth will be isolated  and access prepration will be done.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahriar Shahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 2 Cental Building ,Tabriz University of Medical Science,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>Dental and Periodontal Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahriar Shahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No2 Central Building , 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>Subjects 18-65 years of age
No sensitivity to anesthetic agent
No facial parasthesia
Do not use of any narcotic drug 6 hours before treatment
Patient not to be pregnancy
No history of truma
Absence of pathologic pockets during probing
Patient with mandibular first molar with symptomatic irriversible pulpitis
Normal view of teeth in periapical region</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any patients have not inclusion criteria
Any illness that is unable to fill the informed consent form
Absence of vital pulp tissue in access cavity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulpitis</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:IANB(Inferior alveolar nerve block) standard injection  using prilocaine 3%  solution (Prilocaine,  Felypressin 0.03 IU/Darou Pakhsh,Iran ) will be done . 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 will be injected and after 5 minutes the access cavity will be prepared.</i_keyword>
      <i_keyword>Intervention group 3:After IANB injection and 15 minute timeout and anesthesia of the lips, second IANB injection will be done.and after 5 minutes the access cavity will be prepared.</i_keyword>
      <i_keyword>Control group:In the control group, standard block injection using Prilocaine 3% solution (Prilocaine,  Felypressin 0.03 IU/Darou Pakhsh,Iran) will be done . After 15 minutes and anesthesia of the lips, teeth will be isolated  and access prepration will be done.</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: Using Visual Analog 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>2017-09-30</approval_date>
        <contact_name>Ethics committe of Tabriz University of Medical Sciences</contact_name>
        <contact_address>3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
