<?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>IRCT20230714058773N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-10</date_registration>
      <primary_sponsor>Armed forces institute of dentistry CMH Rawalpindi</primary_sponsor>
      <public_title>Comparison of celecoxib versus acetaminophen as pre-emptive analgesics for the management of post operative pain after impacted mandibular third molar surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of celecoxib versus acetaminophen as pre-emptive analgesics for the management of post operative pain after impacted mandibular third molar surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72955</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: Third molar surgery. Condition 2: Pain. Condition 3: Celecoxeb.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:35 patients received an oral dose of 200 mg of Celecoxeb 30 minutes before surgery. All operations were performed by the same surgeon and the efficacy of both drugs were evaluated by the same surgeon. Patients were educated properly on how to record their pain intensity on the visual analogue scale by placing a vertical mark across the horizontal line of the VAS at the point they felt the pain at 4, 6 and 8 hours after urgery. Each patient revisited for follow­ up with their records of pain at 4, 6 and 8 hours after surgery and total number of tablets consumed within 24 hours. Intervention 2: Control group:35 patients received an oral dose of 500 mg of acetaminophen 30 minutes before surgery. All operations were performed by the same surgeon and the efficacy of both drugs were evaluated by the same surgeon. Patients were educated properly on how to record their pain intensity on the visual analogue scale by placing a vertical mark across the horizontal line of the VAS at the point they felt the pain at 4, 6 and 8 hours after urgery. Each patient revisited for follow­ up with their records of pain at 4, 6 and 8 hours after surgery and total number of tablets consumed within 24 hours.</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>Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Range road Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>Tehminamaryam27@gmail.com</email>
        <affiliation>Armed forces institute of dentistry CMH Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tehmina Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Armed forces institute of dentistry CMH Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 9576737</telephone>
        <email>Tehminamaryam27@gmail.com</email>
        <affiliation>Armed forces institute of dentistry CMH Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female aged from 17 to 50 years old
Patients with at least one impacted mandibular third molar that is indicated for surgical extraction and also confirmed by periapical radiographs including mesioangular, distoangular, horizontal and vertical impactions
Patients with no intake of analgesic and anti-inflammatory drugs for 1 week.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with conditions in which the use of NSAIDs and COX-2 inhibitors is contraindicated.
Patients with serious diseases like liver, kidney and cardiovascular diseases
Pregnant or nursing women
Patients with ulcers or bleeding in the digestive tract.
Patients who are unable to express subjective discomfort symptoms.
Patients with periodontal disease involving the adjacent teeth</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K01.1</hc_code>
      <hc_code>R52</hc_code>
      <hc_code>Y45.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impacted teeth</hc_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
      <hc_keyword>Other nonsteroidal anti-inflammatory drugs [NSAID]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:35 patients received an oral dose of 200 mg of Celecoxeb 30 minutes before surgery. All operations were performed by the same surgeon and the efficacy of both drugs were evaluated by the same surgeon. Patients were educated properly on how to record their pain intensity on the visual analogue scale by placing a vertical mark across the horizontal line of the VAS at the point they felt the pain at 4, 6 and 8 hours after urgery. Each patient revisited for follow­ up with their records of pain at 4, 6 and 8 hours after surgery and total number of tablets consumed within 24 hours.</i_keyword>
      <i_keyword>Control group:35 patients received an oral dose of 500 mg of acetaminophen 30 minutes before surgery. All operations were performed by the same surgeon and the efficacy of both drugs were evaluated by the same surgeon. Patients were educated properly on how to record their pain intensity on the visual analogue scale by placing a vertical mark across the horizontal line of the VAS at the point they felt the pain at 4, 6 and 8 hours after urgery. Each patient revisited for follow­ up with their records of pain at 4, 6 and 8 hours after surgery and total number of tablets consumed within 24 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 30 minutes before intervention and 4,6,8 hours after intervention. Method of measurement: The visual analogue scale comprised a horizontal line, 10cm in length with word descriptors at each endpoint, 0 at the left end presenting "no pain" and point 10 at the right end representing "worst possible pain.".</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>Armed forces institute of dentistry CMH Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-21</approval_date>
        <contact_name>Ethics committee of armed forces institute of dentistry CMH Rawalpindi</contact_name>
        <contact_address>Range road Rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
