<?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>IRCT20191030045286N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-12</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of effects of tissue adhesive on Impacted Third Molar Teeth surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Silk Sutures and Tissue Adhesives for wound closure of Impacted Third Molar Teeth surgery: Clinical and Histological Evaluation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43621</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is simply individual and is done by random number table,even numbers are for group A (suture) and odd numbers are for group B (tissue adhesive).We close our eyes and select the number by our finger,If the even number is selected, we close the wound of right side of the jaw with sutures and if odd number is selected,we close the wound of that side of the jaw with tissue adhesive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Impactd teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 2-ethyl-cyanoacrylate tissue adhesive(EPIGLU,Meyer-Haake Co.Germany) will be used in intervention group for surgery wound closure.Tissue adhesive will be used based on the instructions on the package. Intervention 2: Control group: Non-Absorbable 3/0 silk suture will be used in control group by simple interrupted suture techniqe for surgery wound closure.(SUPASIL Non-Absorbable 3/0 braided silk suture,SUPA MEDICAL DEVICES,Iran).</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Farokhnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental school of Jondishapoor uiversity,Dey St.,Esfand Ave.,Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 990 191 8808</telephone>
        <email>farokhnia.ma@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrokh Raisian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental school of Jondishapur university,Dey St.,Farvardin Ave.,Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 916 111 2507</telephone>
        <email>raisianshahrokh@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All subjects of 18 years and above with mesio-angularly impacted mandibular third molar
Subjects whitout known systemic disease such as bleeding dyscrasia and immunosuppression
Subjects not allergic to the drugs or anaesthetic agents in the surgical protocol
Subjects with good oral hygiene
Subjects who are non-smokers</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subject with severe caries of the second molar teeth
Subject between the age of 18 &amp; 25 who have vertical class 1 and level A pell &amp; gregory classification impaction in third molar teeth</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 - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 2-ethyl-cyanoacrylate tissue adhesive(EPIGLU,Meyer-Haake Co.Germany) will be used in intervention group for surgery wound closure.Tissue adhesive will be used based on the instructions on the package.</i_keyword>
      <i_keyword>Control group: Non-Absorbable 3/0 silk suture will be used in control group by simple interrupted suture techniqe for surgery wound closure.(SUPASIL Non-Absorbable 3/0 braided silk suture,SUPA MEDICAL DEVICES,Iran)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 1,3,7 days after surgery. Method of measurement: by pain Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Wound dehiscence. Timepoint: 1,3,7 days after surgery. Method of measurement: by visual inspection and by gentle probing with a williams probe.</prim_outcome>
      <prim_outcome>Vascularity. Timepoint: 7days after surgery. Method of measurement: By microscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Swelling. Timepoint: Befor surgery and 1,3,7 days after surgery. Method of measurement: Average of tragus to pogonion,tragus to commissure and external canthus to gonion.</sec_outcome>
      <sec_outcome>Trismus. Timepoint: Before surgery and 1,3,7 days after surgery. Method of measurement: Maximum space between mesial and incisal edge of central teeth of maxilla and mandible.</sec_outcome>
      <sec_outcome>Bleeding. Timepoint: 1,3,7days after surgery. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Wound infection. Timepoint: 1,3,7 days after surgery. Method of measurement: Based on purulent discharge from the surgical site.</sec_outcome>
      <sec_outcome>Wound closure time. Timepoint: during surgery. Method of measurement: Recording by using a calibrated stop watch.</sec_outcome>
      <sec_outcome>Inflammatory cell infiltration. Timepoint: 7days after surgery. Method of measurement: By microscope.</sec_outcome>
      <sec_outcome>Fibroblastic activity. Timepoint: 7days after surgery. Method of measurement: By microscope.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-27</approval_date>
        <contact_name>Ahvaz Jondishapur university of medical science</contact_name>
        <contact_address>Jondishapur university of medical science,Esfand St.,farvardin Ave.,Glestan ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
