<?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>IRCT20100427003813N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-02</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effect of plasma rich in growth factors with tunnel technique in the treatment of gingival recession</public_title>
      <acronym></acronym>
      <scientific_title>Study of  the effect of plasma rich in growth factors with tunnel technique in the treatment of gingival recession</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30499</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Surgical areas are randomly divided into two groups by coin throwing method, Blinding description: Patients are unaware of which treatment group they are. The outcome measurer is different from whom that cures patients.</study_design>
      <phase>3</phase>
      <hc_freetext>gingival recession.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: open flap debridement with plasma-rich growth factor. Intervention 2: Control group: Open flap debridement.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Jenabian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganjafrooz Ave.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3220 7918</telephone>
        <email>n.jenabian@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloofar Jenabian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganjafrooz Ave.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3220 7918</telephone>
        <email>n.jenabian@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 18 years old
The presence of single-ended gingival recession of the miller class I / II with a depth of 2 mm = &lt;CEG of the anterior and permoral teeth
alive teeth, without filling or bleeding of probing (The confounding factor is as low as possible)
Ability to maintain proper sanitation(O'LEARY plaque score&lt;=20%)
Keratinized gum width greater than 2mm
Gingival thickness 0.5 = &lt;2mm apical gum margin
Signature of consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Coagulation problems
Use medications of Platelet Interaction (NSAIDs)
Use of drugs which interact with wound healing
Any local or systemic disease that has a contraindication to periodontal treatment.
Allergy to surgical materials (The confounding factor is as low as possible)
Active infectious disease (hepatitis, tuberculosis and AIDS)
smoking
Fernum stretch in the surgical area
Use of traumatic brushing techniques, toothbrushes and abrasive toothbrushes
Use of removable prosthesis plaques in the desired area</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K06.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gingival recession</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: open flap debridement with plasma-rich growth factor</i_keyword>
      <i_keyword>Control group: Open flap debridement</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Keratinized tissue width. Timepoint: before surgery, 6 weeks and 3 months after surgery. Method of measurement: with periodontal probe.</prim_outcome>
      <prim_outcome>Clinical attachment level. Timepoint: before surgery, 6 weeks and 3 months after surgery. Method of measurement: with periodontal probe.</prim_outcome>
      <prim_outcome>Recession width. Timepoint: before surgery, 2 weeks and 3 months after surgery. Method of measurement: with periodontal probe.</prim_outcome>
      <prim_outcome>Vertical Recession Depth. Timepoint: before surgery, 2 weeks and 3 months after surgery. Method of measurement: with periodontal probe.</prim_outcome>
      <prim_outcome>Healing index. Timepoint: 1 and 3 days 1 week and 1 months after surgery. Method of measurement: with healing index (HI) based on Landry index.</prim_outcome>
      <prim_outcome>Clinical Probing Depth. Timepoint: before surgery, 6 weeks, 3 months after surgery. Method of measurement: with periodontal probe.</prim_outcome>
      <prim_outcome>Esthetic Visual Analogue scale. Timepoint: before surgery, 6 weeks, 3 months after surgery. Method of measurement: with Visual analogue scale.</prim_outcome>
      <prim_outcome>Pain Visual Analogue scale. Timepoint: 1, 3 and 7 days after surgery. Method of measurement: whit Visual analogue scale.</prim_outcome>
      <prim_outcome>Distance from cementoenamel junction (CEJ) to mucogingival junction (MGJ or MGJL) in the middle of the buccal surface of the tooth. Timepoint: before surgery, 6 weeks, 3 months after surgery. Method of measurement: with periodontal probe.</prim_outcome>
      <prim_outcome>Percentage of Root Coverage. Timepoint: 3 months after surgery. Method of measurement: [(Vertical Recession Depth before surgery - Vertical Recession Depth after Surgery)/ divided Vertical Recession Depth before surgery]*100.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-26</approval_date>
        <contact_name>Ethics committee of Babol univercity of medical science</contact_name>
        <contact_address>Ganjafrooz Ave. Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
