<?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>IRCT20210508051216N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-31</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of complications of wisdom teeth with surgical and clean gloves</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of bacterial contamination and complications after impacted wisdom tooth surgery using sterile gloves and clean gloves</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56115</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Using limited randomization and the method of random allocation law due to the tendency to choose equal sample size in two groups; the researcher involved based on the sample size of 40 in this study: in the randomization process, 20 sheets with A and 20 The sheet with the number B written on it will be placed in a lottery container and then the papers will be randomly removed from the lottery container and a random sequence will be recorded. To ensure concealment, the names of the selected groups in the envelopes They will be coded according to a random sequence (the researcher will make sure that the envelopes are sealed and similar in appearance) and to ensure compliance with the allocation process to prevent or reduce possible bias, the person involved in creating a random program It will be a separate project from other researchers, Blinding description: Due to the subjectivity of some of the measured complications (pain) of the study, we do it as single blind so that only at the beginning of the study and informed consent to the patient will be told the procedure and whether he is in the group of sterile or non-sterile gloves The patient will remain unaware.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Wisdom tooth surgery completely hidden in mandible with sterile and clean glove.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Use of sterile maxter gloves made in Malaysia for mandibular impact wisdom tooth surgery. Intervention 2: Intervention group: Using op-perfect clean gloves made in Iran for mandibular impact wisdom tooth surgery.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is This study is for thesis.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Oghazian Sabah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arkan Road, next to Imam Hassan Hospital, School of Dentistry</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9417694735</zip>
        <telephone>+98 58 3229 6764</telephone>
        <email>sabah.oghazian1@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Oghazian Sabah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arkan Road, next to Imam Hassan Hospital, School of Dentistry</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9417694735</zip>
        <telephone>+98 58 3229 6764</telephone>
        <email>sabah.oghazian1@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People aged 18-35 who needed widsom tooth surgery compeletly hidden in mandible
All patients are non-smokers and non-alcoholis
All patient should be in ASA1 group.
Patient without systemic disease and immunodeficiency</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are taking antibiotics for the current infection or need antibiotic prophylaxis before surgery.
Patients who surgery lasts more than 30 minutes.
Patient with uncpontrolled diabetes or bleeding disorders.
Paatients receiving steroid therapy.
Patients with a history of head and neck radiotherapy.
Existence of deep caries and the need for root canal thrapy in other teeth and other inflammatory problems such as pericronitis.</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Use of sterile maxter gloves made in Malaysia for mandibular impact wisdom tooth surgery</i_keyword>
      <i_keyword>Intervention group: Using op-perfect clean gloves made in Iran for mandibular impact wisdom tooth surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: One week after lower wisdom tooth surgery. Method of measurement: One week after surgery, all complications such as fever above 37.5 ° C with a thermometer.</prim_outcome>
      <prim_outcome>Pain with a score of 0-10 by the patient. Timepoint: One week after lower wisdom tooth surgery. Method of measurement: Postoperative pain with a score of 0-10 by the patient.</prim_outcome>
      <prim_outcome>Dry socket. Timepoint: One week after lower wisdom tooth surgery. Method of measurement: Persistent throbbing pain.</prim_outcome>
      <prim_outcome>Acute socket inflammation. Timepoint: One week after lower wisdom tooth surgery. Method of measurement: Acute socket inflammation without pus and systemic fever.</prim_outcome>
      <prim_outcome>Acute socket infection,. Timepoint: One week after lower wisdom tooth surgery. Method of measurement: Acute socket infection is associated with pus and systemic fever.</prim_outcome>
      <prim_outcome>Colony- forming unit. Timepoint: One week after lower wisdom tooth surgery. Method of measurement: The number of colony units is calculated by counting the number of colonies formed on the culture medium.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Swelling. Timepoint: One week after surgery. Method of measurement: Swelling of the gums at the surgical site, which may appear asymmetrically on the face.</sec_outcome>
      <sec_outcome>Pus and redness in gingiva. Timepoint: One week after surgery. Method of measurement: Removal of pus from the surgical site and redness of the gums, which can be seen one week after surgery.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-01</approval_date>
        <contact_name>Ethics committee of North khorasan University of Medical Sciences</contact_name>
        <contact_address>N17, Zafar Ave, Baharan Ave, Faramarz Abbasi Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
