<?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>IRCT2012120311656N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-23</date_registration>
      <primary_sponsor>ُShiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of cryotherapy and local corticosteroids in the treatment of oral lichen planus lesions</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of cryotherapy and local corticosteroids in the treatment of oral lichen planus lesions</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral lichen planus.</hc_freetext>
      <i_freetext>Intervention 1: Control Group: Topical corticosteroid in orabase. Intervention 2: Intervention: Cryotherapy with N2O gass.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.ijdr.in/article.asp?issn=0970-9290;year=2014;volume=25;issue=6;spage=711;epage=716;aulast=Amanat</results_url_link>
      <results_summary>Background: Oral lichen planus (OLP) is a chronic inflammatory disease of the oral mucosa with treatment challenges for clinicians.&lt;br /&gt;&#13;
Aims: The objective of this study is to compare the effects of cryotherapy as a new modality with topical corticosteroids as a conventional therapy in the treatment of OLP.&lt;br /&gt;&#13;
Materials and Methods: Thirty patients with bilateral OLP lesions were selected. From each patient a lesion on one side was chosen randomly for a single session of cryotherapy with nitrous oxide gas and the lesion on the other side received triamcinolone acetonide 0.1% ointment orabase. Treatment outcome was measured by means of an appearance score, pain score (visual analogue scale), and severity of lesions before treatment and after 2, 4 and 6 weeks of treatment.&lt;br /&gt;&#13;
Statistical Analysis Used: Paired samples t‑test and Wilcoxon test.&lt;br /&gt;&#13;
Results: In both methods of treatment sign score, pain score and severity of lesions was significantly reduced in all follow‑up sessions (P &lt; 0.05). But the treatment outcome and relapse was not significantly different between the two treatment methods (P &gt; 0.05)&lt;br /&gt;&#13;
Conclusion: Cryotherapy with nitrous oxide gas is as effective as topical triamcinolone acetonide in the treatment of OLP with no systemic side effects and needs less patient compliance. It can be considered as an alternative or adjuvant therapy in OLP patients to reduce the use of treatments with adverse effects.          </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. Maryam Zahed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ghasrodasht, Ghomabad, Shiraz Dental School</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1648 6702</telephone>
        <email>maryamzhd@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences, Dental school</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Dariush Amanat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghasrodasht, Ghomabad, Shiraz Dental School</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1628 6777</telephone>
        <email>amanatd@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences, Dental school</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
•	Clinical diagnosis of oral lichen planus&#13;
•	Existence of two lesions with similar clinical appearance (with the size difference of less than 1 cm) on the right and left buccal mucosa or right and left side of tongue&#13;
•	Not received any treatment for the lesions for at least 2 weeks ago&#13;
•	Signing the consent form.&#13;
Exclusion criteria:&#13;
•	Using drugs that are proved to develop lichenoid lesions.&#13;
•	Lesions seen in contact with dental amalgam &#13;
•	Coexisting dermal and genital lesions&#13;
•	Hypersensitivity to drugs being used&#13;
•	Pregnant women&#13;
•	Systemic disease such as systemic lupus erythematosus, erythema multiform, secondary syphilis, graft versus host disease or others systemic disease.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L43</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 - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control Group: Topical corticosteroid in orabase</i_keyword>
      <i_keyword>Intervention: Cryotherapy with N2O gass</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction in severity of lesions. Timepoint: 2  weeks after treatment. Method of measurement: cilinical judgement of a capable cilinician.</prim_outcome>
      <prim_outcome>Lesion size. Timepoint: 2, 4, 6, 8, 10, 12 weeks after treatment. Method of measurement: with a digital culis.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 2, 4, 6, 8, 10, 12 weeks after treatment. Method of measurement: Visual analogue score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction of each individual treatment. Timepoint: 3 months after treatment. Method of measurement: by asking the patient to give a percentage of satisfaction for each side.</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>ُShiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-04</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand street Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
