<?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>IRCT20230802059009N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-26</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of injectable and topical dexamethasone on dental surgery complications</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Clinical Effect of Injectable and Topical Dexamethasone on Complications After Mandibular Third Molar Surgery- A Clinical Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71802</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, random block method will be used to assign samples to groups. Blocks will be considered as 3 blocks. Group type selection for each person will be done through the following site.
www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: The study is double-blinded, and the surgeon and the researcher will not know about the patient groups. Only one person (student) who administers anesthetic and corticosteroid injection will be aware of the group of patients. The surgeon and the person who follows up the patients and records their pain and swelling levels will not know about the patient group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>impacted third molars.</hc_freetext>
      <i_freetext>Intervention 1: Control group: This group only receives  painkillers (400 mg ibuprofen) after surgery. Patients are advised to use this painkiller every 8 hours if they feel any pain. Intervention 2: Intervention group 1: In this group, after surgery, 2 ml of dexamethasone 8 mg (Daro Pasha, Tehran, Iran) will be injected into the medial pterygoid  muscle with a 24-gauge syringe, and ibuprofen 400 mg will be prescribed. Intervention 3: Intervention group 2: In this group, after the surgery, 10 mg of dexamethasone sodium phosphate powder (Daro Pasha, Tehran, Iran) will be gradually placed in the socket of the extracted tooth, and 400 mg ibuprofen pain reliever will also be prescribed.</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 data exists</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheil Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moallem avenue</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۹۷۱-۴۸۱۵۷</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>soheil.soltani2016@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Amirhossein Moaddabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Moallem avenue</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۹۷۱-۴۸۱۵۷</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>a.moaddabi2@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age of 17 to 35
personal informed consent
having mesioangular impacted 3rd molar in the mandible
not having a history of antibiotic consumption over the last 3 weeks</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>systemic diseases such as diabetes or blood pressure
Being allergic to dexamethasone
Having pericoronitis or infection
pregnancy
drug consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K01.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impacted teeth</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>Control group: This group only receives  painkillers (400 mg ibuprofen) after surgery. Patients are advised to use this painkiller every 8 hours if they feel any pain</i_keyword>
      <i_keyword>Intervention group 1: In this group, after surgery, 2 ml of dexamethasone 8 mg (Daro Pasha, Tehran, Iran) will be injected into the medial pterygoid  muscle with a 24-gauge syringe, and ibuprofen 400 mg will be prescribed.</i_keyword>
      <i_keyword>Intervention group 2: In this group, after the surgery, 10 mg of dexamethasone sodium phosphate powder (Daro Pasha, Tehran, Iran) will be gradually placed in the socket of the extracted tooth, and 400 mg ibuprofen pain reliever will also be prescribed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Swelling. Timepoint: before surgery, 2 days, and 7 days after surgery. Method of measurement: The amount of swelling will be measured clinically, from the tragus of the ear to the outer corner of the mouth on the surgical side by a tape adjusted to the natural concavity of the patient's face.</prim_outcome>
      <prim_outcome>Trismus. Timepoint: before surgery, 2 days, and 7 days after surgery. Method of measurement: The maximum opening of the mouth will be checked by measuring the distance between the incisal edge of the central teeth with a ruler.</prim_outcome>
      <prim_outcome>Pain after wisdom tooth surgery. Timepoint: before surgery, 2 days, and 7 days after surgery. Method of measurement: visual analogue scale (VAS) will be used to measure pain. In addition, the number of pills used is also effective in measuring the pain level of patients.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-14</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moallem avenue Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
