<?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>IRCT20230713058771N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-26</date_registration>
      <primary_sponsor>Islamic International Dental Hospital</primary_sponsor>
      <public_title>Effect of Ibuprofen and  Ibuprofen/Dexamethasone Infiltration on Post- Operative Pain in Single Visit Endodontics</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Ibuprofen and  Ibuprofen/Dexamethasone Infiltration on Post- Operative Pain in Single Visit Endodontics</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71324</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After proper history taking , investigations and formal consent. Subject was considered in one of our two groups by random allocation (lottery method). In this method each subject was asked to pick a sealed envelope out of the total 90. Each sealed envelope marked which group the subject will be put in. This was concealed from the subject, Blinding description: In Group A, after RCT, single shot local infiltration of 0.5 mg dexamethasone will given in periapical area. In Group B, after RCT local infiltration  single shot of placebo(saline)  0.5 mg will be given at periapical area. ( similar delivery  method for both groups)Both patient groups were prescribed ibuprofen 400mg three times a day.</study_design>
      <phase>2</phase>
      <hc_freetext>non vital asymptomatic teeth with necrotic pulp that require endodontic treatment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  group A ibuprofen/dexamethasone infiltration. for this group all participants  were given a single infiltration of 0.5 mg dexamethasone at the periapical tissue region. After the completion  of root canal therapy. Intervention 2: Control group: group B.  for this group  of participants a single infiltration  of 0.5 mg of normal saline ( placebo) was given at the periapical  region after completion  of root canal therapy.</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 No further information as for now</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. ABID HUSSAIN</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St. 41 7th Ave, G-7/4 G 7/4 G-7, Islamabad, Islamabad Capital Territory</address>
        <city>ISLAMABAD</city>
        <country1>Pakistan</country1>
        <zip>P34H+5Q9</zip>
        <telephone>+92 51 8108795</telephone>
        <email>qazii.abid@hotmail.com</email>
        <affiliation>Islamic International Dental Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Asim Qureshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riaz house  hill street opposite hotel one</address>
        <city>Abbottabad</city>
        <country1>Pakistan</country1>
        <zip>224400</zip>
        <telephone>+92 992 406585</telephone>
        <email>asimovtm@gmail.com</email>
        <affiliation>Ayub medical &amp; dental college</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients of both genders aged 16-45 years with non-vital asymptomatic maxillary single rooted tooth with necrotic pulp.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Teeth having extensive intra canal calcification.
•	Teeth with incompletely formed apices
•	Teeth requiring retreatment
•	Taking analgesics, anti-inflammatory or tri-cyclic anti-depressants
•	Allergy to endodontic medication
•	Teeth with grade II or III mobility (more than 2 mm)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  group A ibuprofen/dexamethasone infiltration. for this group all participants  were given a single infiltration of 0.5 mg dexamethasone at the periapical tissue region. After the completion  of root canal therapy</i_keyword>
      <i_keyword>Control group: group B.  for this group  of participants a single infiltration  of 0.5 mg of normal saline ( placebo) was given at the periapical  region after completion  of root canal therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post operative pain. Timepoint: 24, 48, 72 hours after procedure. Method of measurement: visual analog 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>Islamic International Dental Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-04</approval_date>
        <contact_name>The ethical committee at Islamic International Dental Hospital</contact_name>
        <contact_address>7th avenue G7/4 , Islamabad Islamabad Federal capital Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
