<?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>IRCT2015041521780N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-23</date_registration>
      <primary_sponsor>Vice Chancellor Research of Dental Faculty of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison  of Manual and Rotary Instrumentation Techniques on Postoperative Pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Manual and Rotary Instrumentation Techniques on Postoperative Pain in Mandibular Molar Teeth with Asymptomatic Irreversible Pulpitis: A Prospective Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18990</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postoperative Pain.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Instrumentation and treatment of  mandibular first and second molar canals with  rotary RaCe system by 7  RaCe rotary files and crowndown technique according to manufacturers instructions in one visit. Intervention 2: Second intervention group:Treatment and instrumentation of mandibular first and second molars canals with manual k-flexofiles and k-files by stepback technique in one visit.</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>Saied Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Ave.Faculty of Dentistry.Tabriz University of Medical Sciences,Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165919741</zip>
        <telephone>+98 41 3544 6872</telephone>
        <email>rahimis@tbzmed.ac.ir ;  talebzadeh.g@gmail.com ;  nima_talebzade@yahoo.com</email>
        <affiliation>Endodontic Department of Faculty of Dentistry of Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saied Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Ave.Faculty of Dentistry.Tabriz University of Medical Sciences.Tabriz. Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165919741</zip>
        <telephone>+98 41 3544 6872</telephone>
        <email>rahimis@tbzmed.ac.ir  ;  talebzadeh.g@gmail.com  ;  nima_talebzade@yahoo.com</email>
        <affiliation>Endodontic Department of Faculty of Dentistry of Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Age over than 18 years old ;  With pulpal  status of asymptomatic irreversible pulpitis ; Normal periradicular status  radio graphically ; Systemically healthy ; Conducive to restoration ; Needing selective one-visit treatment ;  Presence of lip sign after administration of anesthesia ; Presence of bleeding after exposure of the pulp ; Teeth with 3 or 4 root canals ; No drug use or use of 400 mg of ibuprofen during the 24-hour postoperative interval ; Straight with not difficult to access SLA.&#13;
Exclusion Criteria: Age Under than 18 years old ;  Healthy pulpal  status or reversible pulpitis or symptomatic irreversible pulpitis or necrosis ;  Widening of PDL or radiolucency or radiopacity in the origin of   periradicular ; Systemic disease ; Breast-feeding ; Pregnancy ; Hypersensitivity to lidocaine ; Impossible to restore the teeth ; Presence of a crown before the procedure ; Needing 2-visit treatment or any extra procedure such as incision and drainage  ; Absence of lip sign after administration of anesthesia ; Absence of bleeding after exposure of the pulp ; Teeth with 1 or 2 root canals ; The presence of a difficult root canal anatomy (root canals with extreme curvatures (over 30°) and C-shape canals) ; Internal or external resorption ; Teeth with open apices ;  Radiographically untraceable canal path or any accident or complication occurring during treatment (calcified canals, inability to achieve apical patency in any canal) ; Use of analgesics 12 hours before treatment ; Use more than  400 mg of ibuprofen during the 24-hour postoperative interval or any dose after 24 hours ; Severe labial or lingual malpositioning of teeth  making it difficult to access SLA ; More teeth needing RCT on the same side.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E18,E19,E2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>XVIIIInjury, poisoning and certain other consequences of external causes   	   	XX External causes of morbidity and mortality   	   	XXI Factors influencing health status and contact with health services</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Instrumentation and treatment of  mandibular first and second molar canals with  rotary RaCe system by 7  RaCe rotary files and crowndown technique according to manufacturers instructions in one visit.</i_keyword>
      <i_keyword>Second intervention group:Treatment and instrumentation of mandibular first and second molars canals with manual k-flexofiles and k-files by stepback technique in one visit.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative Pain. Timepoint: 4,8,12,24,48 hour and one week intervals. Method of measurement: Use of Visual Analog Scale(VAS) picture.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Use of Analgestic Drugs (ibuprofen 400 mg). Timepoint: In first 24 hours until one week(use or not use  of analgestic drugs in first 24 hours until one week). Method of measurement: Ask the pationts.</sec_outcome>
      <sec_outcome>The number of painless pationts. Timepoint: 4,8,12,24,48 hours and one week intervals. Method of measurement: Use of Visual Analog Scale(VAS) picture.</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 Research of Dental Faculty of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-05</approval_date>
        <contact_name>Ethics of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor Research.Third floor.Number 2 central building.Golgasht street.Tabriz Medical University. Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
