<?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>IRCT20220108053665N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-24</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using sodium hypochlorite detergent at different temperatures and concentrations on pain intensity after endodontic treatment</public_title>
      <acronym></acronym>
      <scientific_title>comparison of pain scale after single-visit root canal treatment by different temperatures and concentrations of NaOCl in mandibular molars with irreversible pulpitis: Double-blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All stages of treatment will be performed in Tabriz Dental School. These 72 people are randomly assigned to the 6 groups mentioned using RandList software. All random numbers are written on a piece of paper. The sheets are folded and placed in a container. For each number, one of the groups is selected. The syringes containing the washing solution are covered with a layer of opaque coating. Each patient chooses a sheet and uses one of the detergents for that patient based on the selected number. Thus, neither the patient nor the researcher is aware of the type of treatment chosen and the study will be double blind, Blinding description: The syringes containing the washing solution are covered with a layer of opaque coating. Each patient chooses a sheet and uses one of the detergents for that patient based on the selected number. Thus, neither the patient nor the researcher is aware of the type of treatment chosen and the study will be double blind.
To blind the study, all steps of sodium hypochlorite solution preparation will be performed by a trained assistant who has no role in the clinical process, and to prevent the researcher from feeling the temperature of the washing solutions, an insulating coating will be used on the washing syringes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irreversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 40 ° C. Intervention 2: Intervention group 2: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 22° C. Intervention 3: Intervention group 3: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 40 ° C. Intervention 4: Intervention group 4: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 2.5° C. Intervention 5: Intervention group 5: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 2.5° C. Intervention 6: Intervention group 6: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 22° C.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi Mokhtari Zanuzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>mokhtari.z.h@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi Mokhtari Zanuzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry faculty, Tabriz University of Medical Sciences, Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5921</telephone>
        <email>mokhtari.z.h@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Systemically healthy patient
Patient age 18-65 years
No hypersensitivity to epinephrine and sodium hypochlorite
No facial paraesthesia
Do not take any palliatives 12 hours before treatment
Do not take any drugs that Anesthesia interferes
No history of trauma
No pathological envelope during probing
Completion of ethical questionnaire and willingness to participate in the study
Lower molar teeth with irreversible pulpitis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No lip anesthesia after 15 minutes of block injection8
Pain for no reason before treatment
Pregnancy and lactation
Severe periodontal disease
Teeth that can not be isolated with a rubberdam
Root canal calcification
Tooth with severe unrestorable caries
Use of a specific drug or narcotic</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irreversible pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 40 ° C</i_keyword>
      <i_keyword>Intervention group 2: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 22° C</i_keyword>
      <i_keyword>Intervention group 3: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 40 ° C</i_keyword>
      <i_keyword>Intervention group 4: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 2.5° C</i_keyword>
      <i_keyword>Intervention group 5: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 2.5° C</i_keyword>
      <i_keyword>Intervention group 6: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 22° C</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Immediately after treatment, 3, 24, 48, 72 hours and 7 days 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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-27</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
