<?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>IRCT2014040717166N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-17</date_registration>
      <primary_sponsor>Reserch Center of Tehran azad university of medical sciences</primary_sponsor>
      <public_title>effect of an oily calcium hydroxide suspensin on complications after third molar surgery</public_title>
      <acronym></acronym>
      <scientific_title>effect of an oily calcium hydroxide suspension on pain and complications after surgical removal of impacted third molar</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15853</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>impacted third molar.</hc_freetext>
      <i_freetext>Intervention 1: intervention: after surgical removal of tooth ,the socket was chosen randomized and it was filled with OCHS (OSTEORA® 0.5 ml) until it got overfilled. Intervention 2: control:after surgical removal of impacted third molar On the other side we just pretended to put it in the socket (control group) and the patient was convinced that we had put the material on the both sides.</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>dr. saifollah hemmat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no. 4 , 10th neyestan, pasdaran street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19486</zip>
        <telephone>+98 21 2256 4570</telephone>
        <email>info@dfau.com</email>
        <affiliation>tehran azad university of medical sciences, dental faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr. saifollah hemmat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no.4, 10th neyestan, pasdaran street</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19486</zip>
        <telephone>+98 21 2256 4570</telephone>
        <email>info@dfau.com</email>
        <affiliation>tehran azad university of medical sciences , dental faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients whom underwent this surgery were between 17-40 years old that had the indication for exacting wisdom tooth surgery; had bilateral teeth (maxilla or mandible) and these teeth had the same criteria as in four point trauma rating scale and Pederson. Patients  consciously agreed to cooperate with this study and promising incorporation.&#13;
patients will be excluded if: having acute or chronic pericoronitis; using drugs except the drugs which were considered in the study; their disinclination for evaluation; not filling out or handing the forms; having systemic problems; pregnancy; considered drug prohibition for the patient; having allergic history to the considered drug; having painful conditions in the mouth like having teeth with root canal therapy indication; having any algogenic condition in the body; having nervous system diseases; having a need for prophylaxis; patients using steroids, antidepressant, antibiotics, analgesics; having complications during surgery; inferior alveolar canal exposure; applying more traumatic pressure in one side; having the condition that four bony walls were not available for putting the material; condition were having same numbers of sutures were not possible; disability in suturing the flap completely.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k01.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Embedded and impacted teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention: after surgical removal of tooth ,the socket was chosen randomized and it was filled with OCHS (OSTEORA® 0.5 ml) until it got overfilled</i_keyword>
      <i_keyword>control:after surgical removal of impacted third molar On the other side we just pretended to put it in the socket (control group) and the patient was convinced that we had put the material on the both sides</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: immediate,1,6,12,24,32,48,72 hours after surgery. Method of measurement: The amount of pain depending on VAS of pain.</prim_outcome>
      <prim_outcome>Healing. Timepoint: immadiate,3 and 7 days after surgery. Method of measurement: with healing scale.</prim_outcome>
      <prim_outcome>Dry socket. Timepoint: 3-4 days after surgery. Method of measurement: inspection of signs and symptoms.</prim_outcome>
      <prim_outcome>Infection. Timepoint: 3-7 days after surgery. Method of measurement: inspection of signs and symptoms.</prim_outcome>
      <prim_outcome>Bleeding. Timepoint: immediate,8-24 hours , 24-72 hours after surgery. Method of measurement: inspection of signs and symptoms.</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>Reserch Center of Tehran azad university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-12-11</approval_date>
        <contact_name>islamic azad university of medical sciences, dentistry faculty</contact_name>
        <contact_address>no.4 , 10th neyestan, pasdaran street tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
