<?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>IRCT2016012312847N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-02</date_registration>
      <primary_sponsor>Vice Chancellor for research of Shahid Sadooghi University Of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Benzydamine HCl 0.15% mouthwash and Ibuprofen effect on pain relief after crown lengthening, a clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Benzydamine HCl 0.15% mouthwash and Ibuprofen effect on pain relief after crown lengthening, a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12869</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>crown lengthing surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: rinse with benzydamine hydrochloride mouthwash 0.15% (the pharmaceutical company "Exir" Boroujerd) at a rate of once every 3 hours 15 ml for 30 seconds in mouth. Intervention 2: Control group: consume ibuprofen 400 mg tablets every 6 hours (the pharmaceutical company "Hakim").</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>Arezoo Khbazian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dahe Fajr Blv, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3625 0395</telephone>
        <email>arezookhabazian@yahoo.com; roseinthepalace@ymail.com</email>
        <affiliation>Shahid Sadooghi University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezoo Khabazian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dahe Fajr Blv, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3625 0395</telephone>
        <email>arezookhabazian@yahoo.com</email>
        <affiliation>Shahid Sadooghi University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Periodontal health establishment؛ require crown lengthening surgery in the posterior teeth؛ avoiding the use of any painkiller or anti-inflammatory or Counter during the last 6 months؛ lack of systemic problems؛ lack of contraindications of ibuprofen or Benzydamine hydrochloride mouthwash. Benzydamine hydrochloride contraindications include hypersensitivity to the drug or formulation components؛ children under 12 years of age؛ past medical history and feed intake. Warning of eye contact with the drug. The classification used in pregnancy؛ is in category C. It should not be administered to a patient more than 7 days؛ and in case of allergies؛ medication should be discontinued. Information on medication safety in nursing mothers. Contraindications Ibuprofen include third trimester of pregnancy (the drugs X)؛ such as anaphylaxis or Angioedema history of severe allergic reaction caused by aspirin or other non steroidal anti-inflammatory drugs or nose polyp with spasticity due to an inflammatory disease or ulcerative the upper or lower gastrointestinal tract ؛ hemophilia and other blood disorders؛ including disorders of hemostasis؛ or platelets؛ kidney disorders ؛ stomatitis and elderly patients and patients the risk of gastrointestinal bleeding and ulcers in them is high. Concomitant use of ibuprofen with inhibitors of angiotensin converting enzyme (ACE)؛ one of the quinolone antibacterial agents؛ hypoglycemic sulfonylurea drugs؛ cyclosporine؛ lithium and methotrexate may؛ anticoagulants or thrombolytic؛ triamterene؛ valproic acid؛ aspirin and performance they interference is increasing or decreasing.&#13;
Exclusion criteria: Unwillingness to participate in the plan؛ effective pain medications (analgesics or anti-inflammatory drug or drug) during the last 6 months؛ the risk of systemic problems affecting the periodontal tissues (diabetes؛ hypertension and heart disease؛ vascular)؛ ibuprofen is contraindicated or mouthwash Benzydamine hydrochloride.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: rinse with benzydamine hydrochloride mouthwash 0.15% (the pharmaceutical company "Exir" Boroujerd) at a rate of once every 3 hours 15 ml for 30 seconds in mouth.</i_keyword>
      <i_keyword>Control group: consume ibuprofen 400 mg tablets every 6 hours (the pharmaceutical company "Hakim").</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 24 hours after intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stingling &amp; numbness. Timepoint: 24 hours after intervention. Method of measurement: asking from patient.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>000</sec_id>
        <issuing_authority>000</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for research of Shahid Sadooghi University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-21</approval_date>
        <contact_name>Ethics committee of Shahid Sadooghi University Of Medical Sciences</contact_name>
        <contact_address>Dahe Fajr Blv, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
