<?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>IRCT20240615062144N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-12</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>The evaluation of active irrigation on postoperative pain</public_title>
      <acronym></acronym>
      <scientific_title>The evaluation of different irrigation methods on postoperative pain in nonvital mandibular molars</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77446</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study which is in the form of  randomized blocking  the researcher considers every eligible patient to enter the study as a sample then the patient chooses one card from a pack of 80 cards that on each card their is one letter based on a irrigation method. 
The selected method is performed on the patient and finally, the pain registration form is delivered to the patient and the patient registers her pain, Blinding description: Patient and analyzer person do not know about technique of irrigation  used for patient' tooth.</study_design>
      <phase>2</phase>
      <hc_freetext>Evaluation of effectiveness of activation irrigation methods compared to the conventional method in reducing pain after root canal treatment in non-vital mandibular molar teeth..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the first intervention group,5.25% sodium hypochlorite irrigant  is placed inside the pulp chamber and canals as the final washing step after performing all the usual steps of root canal treatment. Then   with appropriate gutta percha  in size and taper for prepared canal   irrigant raised and lowered in the coronoapical  direction, in this way, the irrigant  solution is activated in the canal for 60 seconds . After active irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals. Intervention 2: Intervention group:  Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the second intervention group, after performing all the usual steps of root canal treatment, as the final irrigation step, the method of activating the 5.25% sodium hypochlorite irrigant  solution with the sonic inducer device from Dentsply company is used. In this group, sodium hypochlorite is placed in the pulp chamber and canals and the tip of the device is placed in the canals and the solution is activated for 60 seconds. After active irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals. Intervention 3: Intervention group:  Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the third intervention group, after performing all the usual steps of root canal treatment, as the final irrigation step, the activation method of 5.25% sodium hypochlorite solution with the ultrasonic inductor device from Eighteeth company is used. In this group, sodium hypochlorite is placed in the pulp chamber and channels, and then the tip of the device is placed in the channels and the irrigant solution is activated for 60 seconds. After active irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals. Intervention 4: Control group:  Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the fourth group, which is the control group, conventional side vented syringes are used as the final irrigation  method after the end of the usual procedures of root canal treatment. 5.25% sodium hypochlorite irrigant  solution is passively placed in the pulp chamber and canals for 60 seconds with conventional syringes. After passive  irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals.</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 data potentially shareable after unidentified individuals.

When:
Access starts after publishing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers have access to data under any circumstances

Where to obtain:
For more information, you can contact the corresponding author via the following email: ahmadyanierfan1@gmail.com

How to obtain:
The applicant has unlimited access to the data after sending the request via email to the corresponding author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gona Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran Blvd.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 918 975 8674</telephone>
        <email>gonamomeni@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gona Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, Pasdaran Blvd.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 918 975 8674</telephone>
        <email>gonamomeni@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are candidates for endodontic treatment  for nonvital mandibular molar
Candidate tooth has endodontic lesion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any systemic condition
Candidate tooth has complicated anatomy, resorption and calcified canals.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Superficial injury of lip and oral cavity</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the first intervention group,5.25% sodium hypochlorite irrigant  is placed inside the pulp chamber and canals as the final washing step after performing all the usual steps of root canal treatment. Then   with appropriate gutta percha  in size and taper for prepared canal   irrigant raised and lowered in the coronoapical  direction, in this way, the irrigant  solution is activated in the canal for 60 seconds . After active irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals.</i_keyword>
      <i_keyword>Intervention group:  Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the second intervention group, after performing all the usual steps of root canal treatment, as the final irrigation step, the method of activating the 5.25% sodium hypochlorite irrigant  solution with the sonic inducer device from Dentsply company is used. In this group, sodium hypochlorite is placed in the pulp chamber and canals and the tip of the device is placed in the canals and the solution is activated for 60 seconds. After active irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals.</i_keyword>
      <i_keyword>Intervention group:  Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the third intervention group, after performing all the usual steps of root canal treatment, as the final irrigation step, the activation method of 5.25% sodium hypochlorite solution with the ultrasonic inductor device from Eighteeth company is used. In this group, sodium hypochlorite is placed in the pulp chamber and channels, and then the tip of the device is placed in the channels and the irrigant solution is activated for 60 seconds. After active irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals</i_keyword>
      <i_keyword>Control group:  Patients who are candidates for root canal treatment for their non-vital mandibular molar teeth and have visited the personal office of Dr. Erfan  Ahmadiani between August and September 1403. These patients are randomly divided into 4 groups. For the fourth group, which is the control group, conventional side vented syringes are used as the final irrigation  method after the end of the usual procedures of root canal treatment. 5.25% sodium hypochlorite irrigant  solution is passively placed in the pulp chamber and canals for 60 seconds with conventional syringes. After passive  irrigation the canals will obturated in the same conditions. The patient does not know the irrigation  method used for her/his tooth. After the end of the treatment process, the patient is given a form containing a visual analog scale that the patient records the level of pain at specific time intervals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative pain intensity. Timepoint: 8,24 and 48 hours after treatment. Method of measurement: 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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-10</approval_date>
        <contact_name>Ethics committee of Kurdestan  University of Medical Sciences</contact_name>
        <contact_address>Pasdaran Street Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
