<?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>IRCT20230313057710N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-02</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of using ibuprofen and netonal drugs before root canal treatment on the pain after treatment in teeth with irreversible pulpitis</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of using ibuprofen and netonal drugs before root canal treatment on the pain after treatment in teeth with irreversible pulpitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were selected by convenience  sampling method. Block randomization method was used for random assignment to groups. Random Allocation Software was used for block randomization. On the first page of this software, the number of groups and sample size were entered. On the next page of the software, it was determined how many blocks should be. Blocks with a length of six cells were selected. In the next step, the software created a list of numbers along with grouping. A number was assigned to each patient in the order of entry, and based on that number, the patients were assigned to one of the three treatment groups: ibuprofen, netonal, or placebo in one of the blocks. This action continued until 20 people were entered in each group and 60 people were selected, Blinding description: All drugs were similar in shape, color and size. In order to simulate the drugs, the tablets were divided into small pieces and then they were put into capsules of the same color and the same size. The placebo substance (sugar) was placed inside the same type of capsules without any need to change.</study_design>
      <phase>3</phase>
      <hc_freetext>Pulpits.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:  Iboprofen tablet: Before the intervention, patients completed the demographic questionnaire, visual analog pain scale, and Wong-Baker shape scale. Intervention group 1 was prescribed a number of 400 mg ibuprofen tablets of Aria Pharmaceutical Company, 30 minutes before endodontic treatment of irreversible pulpitis. Then anesthesia was injected to treat the lower mandibular nerve with two carpools of 1.8 ml lidocaine 2% with epinephrine 1:80000. 10 minutes after anesthesia, pain was recorded by asking the patients. After preparation of the access cavity, the tooth was isolated using a rubber band and the length was determined using radiography information. Filing and flaring of channels was done using step-back method. Normal saline and 2% hypochlorid were used to wash inside the canal. The canals were dried using a paper cone and the canals were filled using gutta percha and ZOE sealer and lateral compression technique at a distance of 0.5 to 1 mm from the radiographic apex. Again, the pain intensity of the patients was recorded. Next, the patients were asked to record their pain 8, 12 and 24 hours after the treatment. Intervention 2: Intervention group2: Natonal tablet: Before the intervention, patients completed a demographic questionnaire, visual analog pain scale, and Wong-Baker shape scale. Intervention group 2 was prescribed a number of 400 mg Natonal tablets of Barij Essance pharmaceutical company, 30 minutes before endodontic treatment of irreversible pulpitis. Then anesthesia was injected to treat the lower mandibular nerve with two carpools of 1.8 ml lidocaine 2% with epinephrine 1:80000. 10 minutes after anesthesia, pain was recorded by asking the patients. After preparing the tooth access cavity, it was isolated using a rubber band and the length was determined using radiographic information. Filing and flaring of channels was done using step-back method. Normal saline and 2% hypochlorid were used to wash inside the canal. The canals were dried using a paper cone and the canals were filled using gutta percha and ZOE sealer and lateral compression technique at a distance of 0.5 to 1 mm from the radiographic apex. Again, the pain intensity of the patients was recorded. Next, the patients were asked to record their pain 8, 12 and 24 hours after the treatment. Intervention 3: Control group: Placebo: Control group: Placebo: Before the intervention, patients completed the demographic questionnaire, visual analog pain scale, and Wong-Baker shape scale. Intervention group 2 was prescribed a number of placebo capsules containing sugar, 30 minutes before endodontic treatment of irreversible pulpitis. Then anesthesia was injected to treat the lower mandibular nerve with two carpools of 1.8 ml lidocaine 2% with epinephrine 1:80000. 10 minutes after anesthesia, pain was recorded by asking the patients. After preparing the tooth access cavity, it was isolated using a rubber band and the length was determined using radiographic information. Filing and flaring of channels was done using step-back method. Normal saline and 2% hypochlorite were used to wash inside the canal. The canals were dried using a paper cone and the canals were filled using gutta percha and ZOE sealer and lateral compression technique at a distance of 0.5 to 1 mm from the radiographic apex. Again, the pain intensity of the patients was recorded. Next, the patients were asked to record their pain 8, 12 and 24 hours after the treatment.</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 It will be available after the article is published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Khosravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Avenu, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>khosravanii.zahra73sums@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr ali sichani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Avenu, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>a.valisichani@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with irreversible pulpitis of mandibular first or second molar teeth who have been referred for treatment, 
The spontaneous tooth pain, according to the Visual Analogue Scale or Wong-Baker figure scale, is at least 30 mm, 
The radiographic appearance of the teeth in these patients is normal, 
Do not have lesion or a sinus tract (chronic periapical abscess),
Give a long response to the electrical pulp test (EPT) and the cold test with a cotton roll cooled by endo-ice.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have used any sedative in the last 12 hours, 
Patients who have used long-term drugs that interact with NSAIDs, 
Patients who are allergic to NSAIDs or lidocaine or have systemic problems,
 Pregnant mothers, 
Teeth with lesions Periapical and chronic periapical abscess, 
Patients with aggressive periodontal disease, 
Patients with unrepairable or previously repaired cavities, 
Patients who have pain in more than one tooth.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k00-k14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of oral cavity, salivary glands and jaws</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:  Iboprofen tablet: Before the intervention, patients completed the demographic questionnaire, visual analog pain scale, and Wong-Baker shape scale. Intervention group 1 was prescribed a number of 400 mg ibuprofen tablets of Aria Pharmaceutical Company, 30 minutes before endodontic treatment of irreversible pulpitis. Then anesthesia was injected to treat the lower mandibular nerve with two carpools of 1.8 ml lidocaine 2% with epinephrine 1:80000. 10 minutes after anesthesia, pain was recorded by asking the patients. After preparation of the access cavity, the tooth was isolated using a rubber band and the length was determined using radiography information. Filing and flaring of channels was done using step-back method. Normal saline and 2% hypochlorid were used to wash inside the canal. The canals were dried using a paper cone and the canals were filled using gutta percha and ZOE sealer and lateral compression technique at a distance of 0.5 to 1 mm from the radiographic apex. Again, the pain intensity of the patients was recorded. Next, the patients were asked to record their pain 8, 12 and 24 hours after the treatment.</i_keyword>
      <i_keyword>Intervention group2: Natonal tablet: Before the intervention, patients completed a demographic questionnaire, visual analog pain scale, and Wong-Baker shape scale. Intervention group 2 was prescribed a number of 400 mg Natonal tablets of Barij Essance pharmaceutical company, 30 minutes before endodontic treatment of irreversible pulpitis. Then anesthesia was injected to treat the lower mandibular nerve with two carpools of 1.8 ml lidocaine 2% with epinephrine 1:80000. 10 minutes after anesthesia, pain was recorded by asking the patients. After preparing the tooth access cavity, it was isolated using a rubber band and the length was determined using radiographic information. Filing and flaring of channels was done using step-back method. Normal saline and 2% hypochlorid were used to wash inside the canal. The canals were dried using a paper cone and the canals were filled using gutta percha and ZOE sealer and lateral compression technique at a distance of 0.5 to 1 mm from the radiographic apex. Again, the pain intensity of the patients was recorded. Next, the patients were asked to record their pain 8, 12 and 24 hours after the treatment.</i_keyword>
      <i_keyword>Control group: Placebo: Control group: Placebo: Before the intervention, patients completed the demographic questionnaire, visual analog pain scale, and Wong-Baker shape scale. Intervention group 2 was prescribed a number of placebo capsules containing sugar, 30 minutes before endodontic treatment of irreversible pulpitis. Then anesthesia was injected to treat the lower mandibular nerve with two carpools of 1.8 ml lidocaine 2% with epinephrine 1:80000. 10 minutes after anesthesia, pain was recorded by asking the patients. After preparing the tooth access cavity, it was isolated using a rubber band and the length was determined using radiographic information. Filing and flaring of channels was done using step-back method. Normal saline and 2% hypochlorite were used to wash inside the canal. The canals were dried using a paper cone and the canals were filled using gutta percha and ZOE sealer and lateral compression technique at a distance of 0.5 to 1 mm from the radiographic apex. Again, the pain intensity of the patients was recorded. Next, the patients were asked to record their pain 8, 12 and 24 hours after the treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulpits Pain. Timepoint: Before treatment, immediately after treatment and 8, 12 and 24 hours after treatment. Method of measurement: Using Visual analogue scale و Wong-Baker ّFigure 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-26</approval_date>
        <contact_name>Research ethics committee  of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
