<?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>IRCT20240109060657N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-12</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The effect of two methods of using dexamethasone in reducing pain after root canal treatment</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of dexamethasone as the final rinse inside the root canal compared to infiltration injection after the end of treatment in reducing pain after root canal treatment in patients with irreversible pulpitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74913</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to three treatment groups A, B, C using the method of random blocks (Balance block randomization), the size of each block is 6 and the total number of blocks is 16 as described in the attached table. Randomization was done using the free database "https://www.sealedenvelope.com/" with Seed=127686074750462.
Therefore, in a randomized controlled clinical trial study, 32 patients in each group included local injection of dexamethasone (group A), final washing inside the canal with dexamethasone (group B) and no use of dexamethasone (group C) in reducing pain after molar root treatment. was included in the study in parallel, Blinding description: In this research, the patients are unaware of the intervention group in which they are placed. Root canal treatment in patients is performed by the therapist (root canal treatment specialist) and the evaluation is done by the student who is unaware of the type of treatment intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Irreversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: dexamethasone infiltration injection; After the end of the root treatment, a carpool (2 ml) of dexamethasone containing 8 mg of dexamethasone phosphate (as disodium salt) from Darou pakhsh company is infiltrated on the buccal side of the tooth. Intervention 2: Intervention group 2: final washing inside the canal with dexamethasone; After the preparation of the root canal and before filling the canal, the canal is washed with dexamethasone from Darou Pakhsh Company, and then the canal is dried and obturated. Intervention 3: Control group: not using dexamethasone; The patient does not receive any intervention with dexamethasone during root canal 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Average amount of pain after treatment recorded by patients in all three groups and analysis of their results

When:
Beginning of the access period from 2024 to 2027

To whom:
The general public

Conditions:
There are no special conditions.

Where to obtain:
Mohammad Sarlak
Email: msarlak269@gmail.com
  Phone: 09184900295

How to obtain:
Send a request to a phone number or email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mina seyed habashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moallem Blvd</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3332 2081</telephone>
        <email>mina.s.habashi.64@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Seyed Habashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moallem blvd</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3332 2081</telephone>
        <email>mina.s.habashi.64@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female patients
Age over 18 years old
Vital pulp with a diagnosis of symptomatic or asymptomatic pulpitis
None of systemic diabetes and cardiovascular diseases and allergic problems
Willingness to cooperate
One-session root canal treatment
The possibility of achieving patency in all canals in preoperative radiography
Absence of periodontal problems</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The complexity of the treatment and the possibility of prolonging the treatment time for more than 2 hours, which can be estimated from the patient's radiograph before starting the treatment.
History of gastric ulcer or gastrointestinal bleeding
History of allergy to NSAIDs or corticosteroids
Risk of renal failure or renal damage</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: dexamethasone infiltration injection; After the end of the root treatment, a carpool (2 ml) of dexamethasone containing 8 mg of dexamethasone phosphate (as disodium salt) from Darou pakhsh company is infiltrated on the buccal side of the tooth.</i_keyword>
      <i_keyword>Intervention group 2: final washing inside the canal with dexamethasone; After the preparation of the root canal and before filling the canal, the canal is washed with dexamethasone from Darou Pakhsh Company, and then the canal is dried and obturated.</i_keyword>
      <i_keyword>Control group: not using dexamethasone; The patient does not receive any intervention with dexamethasone during root canal treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average pain intensity. Timepoint: in the times before intervention, 3 hours after treatment, 6 hours, 12 hours, 24 hours after treatment. Method of measurement: NPRS ( Numeric Pain Rating 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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-26</approval_date>
        <contact_name>Ethics committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Moallem blvd Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
