<?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>IRCT20170916036203N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>dimensional change in gingival graft ,scalpel versus graft</public_title>
      <acronym></acronym>
      <scientific_title>Dimensional changes in free gingival grafts: scalpel versus Er:YAG laser--an rct study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30819</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple individual randomization by sealed envelops, Blinding description: In this study, participant,and data collectors are blind to the study. on the day of surgery the patients will receive the laser light on both side ,but on control side without energy and on the test site the patients will receive energy.on the fallow up visits a person that is blind to the study will record the data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dimensional changes in gingival graft after 6 months.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In these patients, the receptor bed of graft is prepared bye Er: cr: YSGG laser ( manufactured by the United States Biolase company with 2 watts, 50Hz, 60% water and 30% air). In the second stage, which is similar between the two groups, the free gingival graft is harvested from the palatal area and then sutured with nylon 0-4 thread. Intervention 2: Control group: In these patients, the receptor bed of the graft is prepared by the common method, which is  the blade (No. 15). In the second stage, which is similar between the two groups, free gingival graft is harvested from the palatal area and is sutured with nylon 0-4 thread.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Participants' data will be shared after they are unidentified.

When:
Access to data will be available after the publication of the article.

To whom:
Data will be available to researchers inside and outside the university

Conditions:
All data and analyzes are available on referral terms

Where to obtain:
To access, please contact Hamed Rahimi at the email address hamedr2003@yahoo.com.

How to obtain:
After sending a request by email, within a week, data will be shared

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Periodontology, Third floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>+98 21 8821 3507</telephone>
        <email>hamedr2003@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afshin Khorsand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Periodontology, Third floor, Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>+98 21 8821 3507</telephone>
        <email>a_afshin_khorsand@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age older than 18 years requires increased attached gingiva width in the mandibular premolar area(Keratinized gingiva less than 2mm or attached gingiva less than 1mm)
Patients' health in terms of systemic and periodontal conditions (probe depth less than 3 mm or BOP Grade 1 or less)
good plaque control (plaque index less than 20%)
Ability to adapt the patient to the study-related processes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1- heavy smoker (those who smokes more than 10 cigarettes a day)
Having a systemic problem that has a negative effect on wound healing. And taking medications that interfere with surgical repair
pregnant patients
Use of antibiotics over the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of gingiva and edentulous alveolar ridge, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In these patients, the receptor bed of graft is prepared bye Er: cr: YSGG laser ( manufactured by the United States Biolase company with 2 watts, 50Hz, 60% water and 30% air). In the second stage, which is similar between the two groups, the free gingival graft is harvested from the palatal area and then sutured with nylon 0-4 thread</i_keyword>
      <i_keyword>Control group: In these patients, the receptor bed of the graft is prepared by the common method, which is  the blade (No. 15). In the second stage, which is similar between the two groups, free gingival graft is harvested from the palatal area and is sutured with nylon 0-4 thread</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dimensional changes of free gingival grafts in two substrates prepared with Orbium Laser Er: Cr: YSGG and the Scalpel Common Method. Timepoint: 1st, 3rd and 6th months after surgery. Method of measurement: Image J software (mm2).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of surgery. Timepoint: Surgical day. Method of measurement: Time in minutes.</sec_outcome>
      <sec_outcome>Pain. Timepoint: The first 10 days after surgery. Method of measurement: Questionaire (VAS).</sec_outcome>
      <sec_outcome>Swelling. Timepoint: The first 10 days after surgery. Method of measurement: questionnaire and patient examination.</sec_outcome>
      <sec_outcome>Hematoma. Timepoint: the first 10 days after surgery. Method of measurement: questionaire.</sec_outcome>
      <sec_outcome>Colour Match (brightness parameters). Timepoint: 6 month after surgery. Method of measurement: adobe photoshop.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-02</approval_date>
        <contact_name>Ethics Committee of Dentistry Faculty of Tehran University of Medical Sciences</contact_name>
        <contact_address>Dentistry Faculty of Tehran University of Medical Sciences, North Karegar St, Tehran, Iran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
