<?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>IRCT2013061113639N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-07-29</date_registration>
      <primary_sponsor>Deputy For Research</primary_sponsor>
      <public_title>Construction of laser tooth brush ,laser aphthous pen and laser herpetic ulcer pen for improving of gum healthy and mouth wounds</public_title>
      <acronym></acronym>
      <scientific_title>Comparision of  a newly developed laser pen as a home care device versus conventional treatment in reduction of gingival inflammation reduction and acceleration of aphthous and herpetic lesion in up to 15 years old population</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>periodontitis,aphthous ulcer,herpetic ulcer.</hc_freetext>
      <i_freetext>Intervention 1: intervention lased group:The group one (n = 10) is treated with &#13;
660 nm, 40 mW, continuous wave, 566 mw/cm2, class 2M, for five consecutive days (twice per &#13;
day, 30 seconds each session). Intervention 2: intervention group one (lased grouo):a laser tooth brush with wavelength 660nm, output power 40mw,spot size 3mm, power density&#13;
566mw/cm2,irradiation time 10 seconds energy, density5.66 J/cm2, laser tooth brush was perpendicularly applied during laser emission at the labial (buccal) interdental papilla ,every other two days. This method is applied by patient at home, after receiving the face to face education and after getting the best skill training at the office in order to use it at home by wearing eye glasses protector. Intervention 3: intervention lased group:The group one (n = 10) is treated with &#13;
655 nm, 40 mW, continuous wave, 655mw/cm2, class 2M,  30 seconds . this intervention is implemented for herpetic lesion in prodromal and vesicular stages but in the crust stage the laser setting will be the power of 40mw and 120 second irradiation time . Intervention 4: in the first control group for aphthous ulcer we will use non laser red light as placebo ,two times per day for 30seconds  for 5 days. Intervention 5: inthe first control group for herpetic lesion we will use the nonlaser red light as placebo for30seconds in the primordial and vesicle stage and also for 120 seconds in the crust stage in one week. Intervention 6: in the second control group for aphthous ulcer we will use the adcortyl in orabase ointment,4 times per day for 5 days. Intervention 7: in thefirst control group for reduction of the gingival inflammation we will use the nonlaser red lihgt as placebo ,two times per day at the interdental papilla. Intervention 8: in the second control group for reduction of the gingival inflammation reduction we will use the tooth brush plus tooth paste two times per day. Intervention 9: in the second control group for herpetic lesion we will use the acyclovir ointment in the primordial and vesicle stage four times per day in oneweek.</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>Masoud Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy for Health</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00984515521412</zip>
        <telephone>+98 45 1552 1412</telephone>
        <email>m.shabani@arums.ac.ir</email>
        <affiliation>Ardebil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy For Health</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00984515521412</zip>
        <telephone>+98 45 1552 1412</telephone>
        <email>m.shabani@arums.ac.ir</email>
        <affiliation>Ardebil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:up to 15 years old; fulfilment of consent form; suffer from gingivitis and periodontitis; herpetic ulcer and aphthous ulcer&#13;
exclusion criteria: pregnancy; malignancy; photosensitivity; thyroid problems; mental handicap; coagulopathy; corticosteroid application; epilepsy</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>149 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k00-k14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of oral cavity, salivary glands and jaws,Other viral diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention lased group:The group one (n = 10) is treated with &#13;
660 nm, 40 mW, continuous wave, 566 mw/cm2, class 2M, for five consecutive days (twice per &#13;
day, 30 seconds each session).</i_keyword>
      <i_keyword>intervention group one (lased grouo):a laser tooth brush with wavelength 660nm, output power 40mw,spot size 3mm, power density&#13;
566mw/cm2,irradiation time 10 seconds energy, density5.66 J/cm2, laser tooth brush was perpendicularly applied during laser emission at the labial (buccal) interdental papilla ,every other two days. This method is applied by patient at home, after receiving the face to face education and after getting the best skill training at the office in order to use it at home by wearing eye glasses protector.</i_keyword>
      <i_keyword>intervention lased group:The group one (n = 10) is treated with &#13;
655 nm, 40 mW, continuous wave, 655mw/cm2, class 2M,  30 seconds . this intervention is implemented for herpetic lesion in prodromal and vesicular stages but in the crust stage the laser setting will be the power of 40mw and 120 second irradiation time .</i_keyword>
      <i_keyword>in the first control group for aphthous ulcer we will use non laser red light as placebo ,two times per day for 30seconds  for 5 days</i_keyword>
      <i_keyword>inthe first control group for herpetic lesion we will use the nonlaser red light as placebo for30seconds in the primordial and vesicle stage and also for 120 seconds in the crust stage in one week</i_keyword>
      <i_keyword>in the second control group for aphthous ulcer we will use the adcortyl in orabase ointment,4 times per day for 5 days</i_keyword>
      <i_keyword>in thefirst control group for reduction of the gingival inflammation we will use the nonlaser red lihgt as placebo ,two times per day at the interdental papilla</i_keyword>
      <i_keyword>in the second control group for reduction of the gingival inflammation reduction we will use the tooth brush plus tooth paste two times per day</i_keyword>
      <i_keyword>in the second control group for herpetic lesion we will use the acyclovir ointment in the primordial and vesicle stage four times per day in oneweek</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dental microbial plaque index. Timepoint: weekly and monthly. Method of measurement: disclosing agent and periodontal probe and observation.</prim_outcome>
      <prim_outcome>Periodontal pocket index. Timepoint: monthly. Method of measurement: periodontal probe.</prim_outcome>
      <prim_outcome>Gingival bleeding index. Timepoint: weekly and monthly. Method of measurement: periodontal pocket probe and observation.</prim_outcome>
      <prim_outcome>Gingival index. Timepoint: monthly. Method of measurement: periodontal probe and observation.</prim_outcome>
      <prim_outcome>Visual analogue scale(VAS). Timepoint: befor intervention,immediately,daily,. Method of measurement: interview and standard cheklist.</prim_outcome>
      <prim_outcome>Function activity. Timepoint: daily. Method of measurement: interview and standard check list.</prim_outcome>
      <prim_outcome>Ulcer recurrent activity. Timepoint: monthly. Method of measurement: interview and standard check list.</prim_outcome>
      <prim_outcome>Time of cure. Timepoint: daily weekly monthly and annually. Method of measurement: interview and check list.</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>Deputy For Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>research ethical committee of ardebil university of medical sciences</contact_name>
        <contact_address>ardebil university of medical sciences ardebil  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
