<?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>IRCT20210920052527N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-20</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Delayed Infection in Two Types of Wisdom Tooth Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Delayed Infection in Envelope and Three-Corner Flaps in Impact Mandibular Third Molar Surgery, a Prospective Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>202</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Every 4 indicated patients who are referred to dental departments of Shahid Beheshti University, Tehran Azad University,Behfar clinic and Ghazi Tabatabaee for wisdom tooth removal surgery are planned to include in   quadruple blocks. This block is actually a table of 2×2 which its columns title is name of flap and its raws title is the side of surgery.  This blocks include side and type of the first surgery which was extracted from the table in line before: Right side and Three-corner flap, right side and envelope flap, left side and three-corner flap, and left side and envelope flap. These data would be given in 4 sealed pockets to the surgeon and surgeon would pick one of them. After that, surgeon will operate patient according to the selected data. Every 4 patient must undergo surgery according to one of these pockets.The other flap on the other side would be operated according to the picked pockets, Blinding description: Patients and analyzer will not know about the inside of the pocket given to the surgeon.(However patients would be aware of the study. Also patients would find out which tooth undergoes operation.) Also the surgeon would not be informed about which sealed pockets would contain what information. The surgeon will pick up one of the sealed pockets randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>--.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients who undergo third mandibular molar impacted extraction surgery with a three-corner flap at first. After surgery, the flap will suture with a 000 silk sew thread. Second surgery will operate immediately after first surgery. In second surgery, the flap will change. this wound will be suture with a 000 silk sew thread. Patients have to use antiseptics and antibiotics according to the protocols. Intervention 2: Intervention group: Patients who undergo third mandibular molar impacted extraction surgery with a envelope flap at first. After surgery, the flap will suture with a 000 silk sew thread. Second surgery will operate immediately after first surgery. In second surgery, the flap will change. this wound will be suture with a 000 silk sew thread. Patients have to use antiseptics and antibiotics according to the protocols.</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:
The data will be published through the research commits

When:
After finishing the accumulation of the data

To whom:
Dental students , researchers

Conditions:
With permission from the research commits

Where to obtain:
The research commits

How to obtain:
The request from the research committees.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arghavan Alley, Saadat Abad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۸۶۶۶۸۹۸</zip>
        <telephone>+98 21 2208 3106</telephone>
        <email>p.moradi17@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Tabrizi Miyandoab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1963815971</zip>
        <telephone>+98 21 2267 2126</telephone>
        <email>rtabrizi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People Having ASA1 Systemic Condition
People Candidate for Both Mandibular Impacted Third Molar Surgery
Both Impacted Tooth Must be In Same Pell and Gregory Classification
Patient Age Must Be Between 18 to 30 Years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with decayed second mandibular tooth which needs a root canal therapy.
Smoker patients.
Patients who have got a pathologic lesion around impacted wisdom tooth.
Patients with incapability of mouth opening over 35 millimeters.
Patients with poor oral hygiene.
Patients who have got mandible trauma.
Patients who are not capable to come over for a follow-up session.
Patients who do not use antibiotics and antiseptics by regular given order.</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 - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who undergo third mandibular molar impacted extraction surgery with a three-corner flap at first. After surgery, the flap will suture with a 000 silk sew thread. Second surgery will operate immediately after first surgery. In second surgery, the flap will change. this wound will be suture with a 000 silk sew thread. Patients have to use antiseptics and antibiotics according to the protocols.</i_keyword>
      <i_keyword>Intervention group: Patients who undergo third mandibular molar impacted extraction surgery with a envelope flap at first. After surgery, the flap will suture with a 000 silk sew thread. Second surgery will operate immediately after first surgery. In second surgery, the flap will change. this wound will be suture with a 000 silk sew thread. Patients have to use antiseptics and antibiotics according to the protocols.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delayed infection after surgery with pain, redness, swelling, pus discharge and restriction of maximum mouth opening symptoms. Timepoint: 2 weeks after surgery, 4 weeks and 6 weeks. Method of measurement: Clinical evaluation for detection of infection (redness, pain, swelling, pus discharge and restriction of maximum mouth opening).</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 Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-04</approval_date>
        <contact_name>Ethics committee of Tehran Azad University of Medical Sciences.</contact_name>
        <contact_address>No. 9, Arghavan Alley, North Behzad Bolevard, Second Abghari Street, Saadat Abad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
