<?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>IRCT201404071760N34</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-04</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Babol University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of Papilla preservation technique and pouch&amp; tunnel with subepithelial connective tissue graft in dark triangle treatment</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of Papilla preservation technique and pouch&amp; tunnel with subepithelial connective tissue graft in dark triangle treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1298</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Gingival recession.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:&#13;
     The first incision is semilunar 3 mm below MGJ .The second incision is sulcular .In semilunar incision flap is reflected full thickness .SCTG is taken from the palate in premolars site and is sutured with a 4-0 silk suture (Manufacturer: Ethicon, Iran)  that has been previously passed from the papilla .Periodontal pack(non-eugenol, GC, USA) is placed both on donor and recipient site .For all patients CHX 0.12% is prescribed for two weeks twice a day for 30 seconds each time .Systemic antibiotics(Penicillin vk 500 mg qid) is prescribed for one week .Pack and suture are removed after two weeks. Intervention 2: Intervention group 2:&#13;
    Papilla preservation technique :papilla preservation incision is used and in cases where the width of papilla is short for better vascularization the horizontal incision is placed on labial .SCTG is taken from the palate in premolars site and is sutured in papilla with 4-0 silk suture(Ethicon, Iran)There after the horizontal incision is sutured with the same suture .Periodontal pack(Non-eugenol, GC, USA)is placed both in donor and recipient site .CHX 0.12 %  is prescribed for all patients for two weeks twice per day for 30 seconds each time .Systemic antibiotics (Penicillin vk 500 mg qid) is prescribed for one week .Pack and suture are removed after two weeks.</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>Dr. Morteza Rahimi Rad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1229 1408</telephone>
        <email>mortezadds@yahoo.com</email>
        <affiliation>Dental colleges of Babol</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Niloofar Jenabiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1229 1408</telephone>
        <email>njenabian@hotmail.com</email>
        <affiliation>Dental colleges of Babol</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: existence the dark triangle anterior max; Tarnow all black triangles classified under group I, II; the selected teeth vital and no bleeding after probing; people over 18 years old; ability to maintain good oral hygiene (Oleary plaque score &lt;20%); without stretching the frenum&#13;
 Exclusion criteria: pregnancy;  history of blood clotting problems, and hematologic; interfere with the healing agents (corticosteroids, anticancer); drugs interfering with platelet function (NSAIDS); smoking; any local or systemic disease with surgical procedures to prohibit administration; traumatic methods of brushing, toothbrush, toothpaste abrasives or harsh; long-term use of antibiotics in the previous quarter (more than 2 weeks); with known allergies to materials used in surgery; active infectious diseases (tuberculosis, hepatitis, HIV); use of drugs can lead to gingival enlargement.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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 1:&#13;
     The first incision is semilunar 3 mm below MGJ .The second incision is sulcular .In semilunar incision flap is reflected full thickness .SCTG is taken from the palate in premolars site and is sutured with a 4-0 silk suture (Manufacturer: Ethicon, Iran)  that has been previously passed from the papilla .Periodontal pack(non-eugenol, GC, USA) is placed both on donor and recipient site .For all patients CHX 0.12% is prescribed for two weeks twice a day for 30 seconds each time .Systemic antibiotics(Penicillin vk 500 mg qid) is prescribed for one week .Pack and suture are removed after two weeks.</i_keyword>
      <i_keyword>Intervention group 2:&#13;
    Papilla preservation technique :papilla preservation incision is used and in cases where the width of papilla is short for better vascularization the horizontal incision is placed on labial .SCTG is taken from the palate in premolars site and is sutured in papilla with 4-0 silk suture(Ethicon, Iran)There after the horizontal incision is sutured with the same suture .Periodontal pack(Non-eugenol, GC, USA)is placed both in donor and recipient site .CHX 0.12 %  is prescribed for all patients for two weeks twice per day for 30 seconds each time .Systemic antibiotics (Penicillin vk 500 mg qid) is prescribed for one week .Pack and suture are removed after two weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Treatment of dark Triangle. Timepoint: Before surgery and three and six months after surgery. Method of measurement: Indexed Nordland and Tarnow.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>APico - coronal Papilla dimension. Timepoint: Before surgery and three and six months after surgery. Method of measurement: Mm.</sec_outcome>
      <sec_outcome>MOD Papilla dimension. Timepoint: Before surgery and three and six months after surgery. Method of measurement: Mm.</sec_outcome>
      <sec_outcome>Healing. Timepoint: Before surgery and three and six months after surgery. Method of measurement: Healing index.</sec_outcome>
      <sec_outcome>Beauty. Timepoint: Before surgery and three and six months after surgery. Method of measurement: Indexed beauty VAS.</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>Vice Chancellor for Research and Technology, Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-08</approval_date>
        <contact_name>The ethics committee of Babol University of Medical sciences</contact_name>
        <contact_address>Babol University of Medical sciences, Ganjafroz Avenue Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
