<?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>IRCT2015121925610N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences - Dentistry school- Research assistant</primary_sponsor>
      <public_title>effect of Diode and Erbium laser on dark gingival color</public_title>
      <acronym>Gingival Melanin Depigmentation - GMD</acronym>
      <scientific_title>Comparison of treatment outcomes of Diode 808 nm and Er,Cr:YSGG laser on physiologic gingival pigmentation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21384</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Physiologic Gingival Melanin Hyperpigmentation.</hc_freetext>
      <i_freetext>Intervention 1: treatment of physiologic gingival pigmentation in one quadrant of one jaw with Diode laser 808nm - 1 watt - CW. Intervention 2: treatment of physiologic gingival pigmentation in one quadrant of one jaw with Er,Cr:YSGG laser 2780nm- 1.75 watt - 10 % water - 20% Air- 20 HZ- Type MZ8.</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>Somayeh Rahmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry school - Daneshjoo Boulevard - Shahid Chamran High way- Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2240 3075</telephone>
        <email>mahinbakhshi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences - Dentistry school</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry School, Daneshjoo Boulevard, Evin,Shahid Chamran High Way,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2240 3075</telephone>
        <email>Mahinbakhshi@yahoo.com</email>
        <affiliation>Oral Medicine Department , Shahid Beheshti university of Medical Sciences-Dentistry School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
Having physiologic gingival melanin pigmentation;Coordination of gingival pigmentation pattern in left and right side , pigmentation intensity in range of moderate to severe and maximum one score difference in extension of pigmentation; Voluntary participation in study&#13;
Exclusion criteria:&#13;
History of Diabetes or autoimmune disease;Under treatment with drugs that influence on gingival color; Pregnant or breast-feeding women;Evidence about relation of pigmentation with malignancies;History of previous treatment of gingival pigmentation; Smoking;Periodontal disease;Uncoordination of gingival pigmentation pattern in left and right side</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L81.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other melanin hyperpigmentation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>treatment of physiologic gingival pigmentation in one quadrant of one jaw with Diode laser 808nm - 1 watt - CW</i_keyword>
      <i_keyword>treatment of physiologic gingival pigmentation in one quadrant of one jaw with Er,Cr:YSGG laser 2780nm- 1.75 watt - 10 % water - 20% Air- 20 HZ- Type MZ8</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pigmentation. Timepoint: Before intervention - 1 months after intervention - 3 months after intervention - 6 months after intervention. Method of measurement: Dummett–Gupta Oral Pigmentation Index (DOPI; Dummett 1971) : 1. No clinical pigmentation (pink gingiva) 2. Mild clinical pigmentation (mild light brown color) 3. Moderate clinical pigmentation (medium brown or mixed pink and brown) 4. Heavy clinical pigmentation (deep brown or bluish black).</prim_outcome>
      <prim_outcome>Extension of Pigmentation. Timepoint: Before intervention - 1 months after intervention - 3 months after intervention - 6 months after intervention. Method of measurement: – Hedin melanin index scored as follows: 0- No pigmentation  1- One or two solitary units of pigmentation in the papillary gingiva  2- &gt;3 units of pigmentation in the papillary gingiva without formation of a continuous ribbon 3- One short continuous ribbons of pigmentation 4- One c ontinuous ribbon including the entire area between the canines.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: During first 24 hours after intervention. Method of measurement: Question: Visual Analogue Scale Score 0 = no pain Score1 = 1 to 30 mm = slight pain Score2= 31 to 60 mm = moderate pain Score3= 61 to 100 mm= sever pain.</sec_outcome>
      <sec_outcome>Bleeding. Timepoint: During intervention. Method of measurement: inspection: with bleeding - without bleeding.</sec_outcome>
      <sec_outcome>Gingival Recision. Timepoint: 1 months after intervention - 3 months after intervention - 6 months after intervention. Method of measurement: inspection: with recision - without recision.</sec_outcome>
      <sec_outcome>Gingival Healing. Timepoint: one week after first intervention. Method of measurement: inspection: with healing - without healing.</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>Shahid Beheshti University of Medical Sciences - Dentistry school- Research assistant</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-07</approval_date>
        <contact_name>Shahid Beheshti University Of Medical Sciences - Dentistry School</contact_name>
        <contact_address>Dentistry School - Daneshjoo Boulevard - Shahid Chamran High way - Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
