<?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>IRCT20201117049418N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of dexamethasone on tooth extraction</public_title>
      <acronym></acronym>
      <scientific_title>Effect of local dexamethasone on pain, swelling and trismus after impacted third molar extraction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-02-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52349</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple individual randomization with sealed envelops that patient choose the envelope, there were 72 sealed envelopes that each one included group number and patient choose between envelopes and then he/she was included in one group, Blinding description: triple-blind randomized clinical trial study (surgeon, examiner, and statistical analyst
All surgeries were performed by a skilled surgeon without any knowledge of the type of drug intervention. Drug intervention was done by a dentist who was informed about the plan and she was not involved in other steps of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>third molar extraction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1 received dexamethasone powder 4 mg inside the alveolar socket after washing and before flap suturing. Intervention 2: Intervention group: group 2 received dexamethasone 4 mg/ml in the masseter muscle through the oral mucosa before surgery and after anasthesia. Intervention 3: Intervention group:  group 3 received ibuprofen 400 mg tablets one hour before surgery and every 6 hours for one day. Intervention 4: Control group: Control group: A hard gelatin capsule contains starch powder 1gr, was considered as a placebo which consumed orally one hour before surgery (group 4).</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:
whole data are available

When:
from now till 2 years

To whom:
researcher

Conditions:
N/A

Where to obtain:
Farshadkhosraviani@gmail.com

How to obtain:
proposal and aim of their request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farshad Khosraviani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3229 1/2 S Sherbourne Dr</address>
        <city>Los Angles</city>
        <country1>United States of America</country1>
        <zip>90034</zip>
        <telephone>+1 949-771-5704</telephone>
        <email>farshadkhosraviani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farshad Khosraviani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3229 1/2 S Sherbourne Dr</address>
        <city>Los Angles</city>
        <country1>United States of America</country1>
        <zip>90034</zip>
        <telephone>+1 949-771-5704</telephone>
        <email>farshadkhosraviani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>United States of America</country2>
    </countries>
    <criteria>
      <inclusion_criteria>individuals with painful impacted lower third molar
aged over 18 and less than 35
third molar mesioangular deviation in imaging</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant and lactating women
systemic diseases such as diabetes and hypertension
analgesic and anti-inflammatory drug consumption such as NSAIDs and GCs at least one week before surgery
existing or developed infectious conditions such as abscess and surgical site infection
antibiotic use at least one week before surgery
known psychiatric disorders
surgery duration longer than 30 minutes.</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1 received dexamethasone powder 4 mg inside the alveolar socket after washing and before flap suturing</i_keyword>
      <i_keyword>Intervention group: group 2 received dexamethasone 4 mg/ml in the masseter muscle through the oral mucosa before surgery and after anasthesia</i_keyword>
      <i_keyword>Intervention group:  group 3 received ibuprofen 400 mg tablets one hour before surgery and every 6 hours for one day</i_keyword>
      <i_keyword>Control group: Control group: A hard gelatin capsule contains starch powder 1gr, was considered as a placebo which consumed orally one hour before surgery (group 4).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient’s severity of pain was measured by Visual Analogue Scale (VAS). Timepoint: surgery day, two days after surgery and then one week after surgery. Method of measurement: This is a 100-mm ruler, which the patient marks the pain severity on it from zero (painless) to 100 (maximum pain). After receiving training, the patients expressed their severity of pain and recorded it in terms of cm.-.</prim_outcome>
      <prim_outcome>Swelling To measure swelling, the distance of tragus to the corner of the lip and tragus to gonion[. Timepoint: surgery day, two days after surgery and then one week after surgery. Method of measurement: swelling, the distance of tragus to the corner of the lip and tragus to gonion[17] was measured by a standard cloth ruler, and these values were summed and divided by two to obtain the swelling mean in the surgery side in millimeter.-.</prim_outcome>
      <prim_outcome>Trismus In order to assess the maximal mouth opening, patients opened their mouth straight so that they did not have jaw deflection, pain and discomfort. Timepoint: surgery day, two days after surgery and then one week after surgery. Method of measurement: Maximal mouth opening was recorded by measuring the distance between the incisal edges of the upper and lower central teeth using a coulisse ruler in millimeter.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-12</approval_date>
        <contact_name>Institutional Research Ethics Committee School of Dentistry Trhran University of Medical Sciences</contact_name>
        <contact_address>loor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
