<?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>IRCT201506191760N42</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-06</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of releasing (relaxing) incision on the postoperative complication of mandibular third molar surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of releasing (relaxing) incision on the postoperative complication of mandibular third molar surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1306</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is Single blind. All patients underwent surgery by a fall, and assessments before and after surgery by colleagues(provided by flaps on both sides of the patient is not aware of) is done. In order to provide the flap, the choice of the surgery is done by random table and examine the person is unaware of it.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Impacted teeth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention groups:&#13;
 : triangular flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then it is extended in buccal gingival sulcus to mesiobuccal of 2nd molar and finally connected to the releasing incision in mesiobuccal region with at least 1 cm length extension to buccal vestibular. After reflecting full thickness flap, bone removal (Osteoctomy) and if sectioning of third molar (Odontomy) is required, done  by using surgery bur. finally, after full restoration of  homeostasis the flap is re-positioned to primary site and sutured. Intervention 2: Control groups:&#13;
  Envelope flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then is extended from buccal gingival sulcus of second molar to mesiobuccal of second premolar.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Ali Asghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3229 1408</telephone>
        <email>s.aliasgharie@yahoo.com</email>
        <affiliation>Dental colleges of Babol</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramin Frooghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3229 1408</telephone>
        <email>r.frooghi@mubabol.ac.ir</email>
        <affiliation>Dental colleges of Babol</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Age range 15-35 years; Mandibular third molar teeth surgery candidates with Pell &amp; Gregory and classified in categories 1 and 2 -A, B&#13;
Exclusion criteria:&#13;
Smoking;&#13;
Taking certain medications such as Corticosteroids or immunosuppressive drugs bisphosphonates; Illnesses such as diabetes, anemia and other debilitating diseases of the immune system; Haemorrhagic disease or taking anticoagulants; Background radiation in head and neck; pericoronitis or any pathological lesions associated with third molars is not growing; Significant injury periosteal flap envelope in</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Embedded and 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 groups:&#13;
 : triangular flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then it is extended in buccal gingival sulcus to mesiobuccal of 2nd molar and finally connected to the releasing incision in mesiobuccal region with at least 1 cm length extension to buccal vestibular. After reflecting full thickness flap, bone removal (Osteoctomy) and if sectioning of third molar (Odontomy) is required, done  by using surgery bur. finally, after full restoration of  homeostasis the flap is re-positioned to primary site and sutured.</i_keyword>
      <i_keyword>Control groups:&#13;
  Envelope flap incision is started from anterior edge of mandibular ramus and 1 cm distally from second molar then is extended from buccal gingival sulcus of second molar to mesiobuccal of second premolar.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complications After Surgery. Timepoint: Daily up to a month after surgery. Method of measurement: Clinical.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Index. Timepoint: Daily up to a month after surgery. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Inflation. Timepoint: On the third, seventh, fourteenth, and one month after surgery. Method of measurement: Clinical.</sec_outcome>
      <sec_outcome>The Lockjaw. Timepoint: On the third, seventh, fourteenth, and one month after surgery. Method of measurement: Clinical.</sec_outcome>
      <sec_outcome>Ecchymosis. Timepoint: On the third, seventh, fourteenth, and one month after surgery. Method of measurement: Clinical.</sec_outcome>
      <sec_outcome>Duration of surgery. Timepoint: Since the start of operation by the end of the last stitch. Method of measurement: Clinical.</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>Vice Chancellor for Research and Technology, Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-17</approval_date>
        <contact_name>Ethics committee of Babol University of Medical sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganjafroz Avenu Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
