<?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>IRCT20230714058773N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-30</date_registration>
      <primary_sponsor>Department of Oral and Maxillofacial Surgery, Islam Dental College, Sialkot</primary_sponsor>
      <public_title>Comparative Efficacy of Dexamethasone Versus Prednisone in the Prevention of Post-Operative Edema, Pain, and Trismus Following Mandibular Third Molar Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Efficacy of Dexamethasone Versus Prednisone in the Prevention of Post-Operative Edema, Pain, and Trismus Following Mandibular Third Molar Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/92003</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: Eligible participants were randomized in a 1:1 ratio using a computer-generated random number sequence (www.randomizer.org), with allocation concealment maintained through sequentially numbered, opaque, sealed envelopes prepared by an independent statistician not involved in patient care or outcome assessment, Blinding description: Eligible participants were randomized in a 1:1 ratio using a computer-generated random number sequence (www.randomizer.org), with allocation concealment maintained through sequentially numbered, opaque, sealed envelopes prepared by an independent statistician not involved in patient care or outcome assessment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Impacted mandibular third molar.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients received dexamethasone 8 mg administered locally into pterygomandibular 20 minutes prior to the commencement of surgical extraction, plus an oral placebo capsule identical in appearance to the prednisone capsule. Intervention 2: Intervention group: Group B (Prednisone): 40 mg oral, 60 minutes pre-op, plus an intramasseteric normal saline injection.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islam Medical And Dental College, Pasrur road, sialkot, Pakistan</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+98 33 3957 6737</telephone>
        <email>tehminamaryam27@gmail.com</email>
        <affiliation>Department of Oral and Maxillofacial Surgery, Islam Dental College, Sialkot</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islam Medical And Dental College, Pasrur road, sialkot, Pakistan</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+98 33 3957 6737</telephone>
        <email>tehminamaryam27@gmail.com</email>
        <affiliation>Department of Oral and Maxillofacial Surgery, Islam Dental College, Sialkot</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients were eligible for inclusion if they were aged 18–40 years,
had a unilateral impacted mandibular third molar requiring surgical extraction under local anaesthesia,
and were classified as American Society of Anesthesiologists (ASA) Physical Status Class I or II.
The molar had to be classified as Class II Position B impaction on panoramic radiography (Pell and Gregory classification).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria encompassed active systemic illness (diabetes mellitus, hypertension, renal or hepatic disease),
known hypersensitivity or contraindication to corticosteroids,
current use of systemic corticosteroids or non-steroidal anti-inflammatory drugs,
pregnant or lactating women, active pericoronitis or acute pericoronal infection at the surgical site,
active peptic ulcer disease, immunocompromised status, and tobacco or alcohol use disorder.
Patients who required general anaesthesia or sedation were also excluded</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K08.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Retained dental root</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients received dexamethasone 8 mg administered locally into pterygomandibular 20 minutes prior to the commencement of surgical extraction, plus an oral placebo capsule identical in appearance to the prednisone capsule</i_keyword>
      <i_keyword>Intervention group: Group B (Prednisone): 40 mg oral, 60 minutes pre-op, plus an intramasseteric normal saline injection</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Facial edema. Timepoint: at day 2, day 5, day 7. Method of measurement: sum of 3 linear measurements.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Primary: facial edema at baseline,. Timepoint: Day 2, Day 5, Day 7. Method of measurement: sum of 3 linear measurements.</sec_outcome>
      <sec_outcome>Secondary: VAS pain score (0–10), trismus , and adverse events (nausea/vomiting, hyperglycemia, insomnia, dry socket). Timepoint: immediately after, at day 2 and day 5 and 7. Method of measurement: visual analog scale, reduction in maximum interincisal distance from baseline.</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>Department of Oral and Maxillofacial Surgery, Islam Dental College, Sialkot</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-02</approval_date>
        <contact_name>Department of Oral and Maxillofacial Surgery, Islam Dental College, Sialkot, Pakistan</contact_name>
        <contact_address>Islam Medical And Dental College, Pasrur road, sialkot, Pakistan Sialkot punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
