<?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>IRCT20200804048305N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Root coverage with CAF or VISTA</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of root coverage with connective tissue graft associated with coronally advanced flap or vestibular incision subperiosteal tunnel access- Randomizes clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50117</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to one of the study groups with computer generated randomization list.The random allocation sequence will handed to the investigator who performed all of the surgical procedures on the day of surgery, Blinding description: Except the surgeon all of researchers (investigator, outcome assessor, data analyzer) and participants are blind about the procedure.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gingival recession.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The VISTA approach begins with a vestibular access incision using 15c scalpel blade. Two vertical incisions will made on both sides of recession area . This  is  continues  at  the  base  of  the  gingival papillae  without  affecting  their  entirety. A microsurgical periosteal elevator (VISTA 1, Dowell Dental Products) will use to create the subperiosteal tunnel with sufficient extension. An elevator with bayonet curves (VISTA 2 and 3, Dowell Dental Products) facilitates access to the gingival sulcus and interproximal areas .The CTG was guided using a horizontal mattress suture within the tunnel by inserting a 3-0 silk suture with a 26-mm 3/8 circle needle. The CTG and mucogingival complex will then advance coronally and stabilize in the new position with a coronally anchore suturing technique using a 6.0 polypropylene suture. Intervention 2: Control group: Two bevelled oblique, slightly divergent, incisions starting at the end of the two horizontal incisions of the distal and mesial teeth and extending to the alveolar mucosa. All of incisions will made with a 15c scalpel blade.The resulting trapezoidal-shaped flap was elevated with  in the coronal–apical direction up to exposing 3–4mm of bone apical to the bone dehiscence. The CTG is sutured at the recession area with horizontal double mattress using 6.0 polypropylene suture at the level of buccal CEJ.The gingival margin will advance coronally to the most coronal level of the interproximal papillae.</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:
all data

When:
6 month after publication

To whom:
all people

Conditions:
systematic review analysis

Where to obtain:
Dr. Mogharehabed
Mogharehabed@dnt.mui.ac.ir

How to obtain:
-

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Afshari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jareeb street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8146773461</zip>
        <telephone>+98 31 3792 5570</telephone>
        <email>Z.afshar90@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jaber Yaghini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjareeb street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5570</telephone>
        <email>J_yaghini@dnt.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Multiple gingival recession in anterior region of mandible
Systemically healthy with no contraindications for periodontal surgery
No need for orthodontic treatment
No caries or restorations on desired teeth</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic conditions or diseases affecting periodontal health, pregnancy or lactation
Substance abuse, smoking
Use of immunosuppressive or anticoagulant drugs</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:The VISTA approach begins with a vestibular access incision using 15c scalpel blade. Two vertical incisions will made on both sides of recession area . This  is  continues  at  the  base  of  the  gingival papillae  without  affecting  their  entirety. A microsurgical periosteal elevator (VISTA 1, Dowell Dental Products) will use to create the subperiosteal tunnel with sufficient extension. An elevator with bayonet curves (VISTA 2 and 3, Dowell Dental Products) facilitates access to the gingival sulcus and interproximal areas .The CTG was guided using a horizontal mattress suture within the tunnel by inserting a 3-0 silk suture with a 26-mm 3/8 circle needle. The CTG and mucogingival complex will then advance coronally and stabilize in the new position with a coronally anchore suturing technique using a 6.0 polypropylene suture.</i_keyword>
      <i_keyword>Control group: Two bevelled oblique, slightly divergent, incisions starting at the end of the two horizontal incisions of the distal and mesial teeth and extending to the alveolar mucosa. All of incisions will made with a 15c scalpel blade.The resulting trapezoidal-shaped flap was elevated with  in the coronal–apical direction up to exposing 3–4mm of bone apical to the bone dehiscence. The CTG is sutured at the recession area with horizontal double mattress using 6.0 polypropylene suture at the level of buccal CEJ.The gingival margin will advance coronally to the most coronal level of the interproximal papillae.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Root coverage percentage. Timepoint: Base line, 3 months and 6 months later. Method of measurement: Periodontal probe.</prim_outcome>
      <prim_outcome>Complete root coverage. Timepoint: Base line, 3 months and 6 months later. Method of measurement: Periodontal probe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pocket probing depth. Timepoint: Base line, 3 months and 6 months later. Method of measurement: Periodontal probe.</sec_outcome>
      <sec_outcome>Clinical attachment level. Timepoint: Base line, 3 months and 6 months later. Method of measurement: Periodontal probe.</sec_outcome>
      <sec_outcome>Keratinized tissue width. Timepoint: Base line, 3 months and 6 months later. Method of measurement: Periodontal probe.</sec_outcome>
      <sec_outcome>Recession width. Timepoint: Base line, 3 months and 6 months later. Method of measurement: Periodontal probe.</sec_outcome>
      <sec_outcome>Recession depth. Timepoint: Base line, 3 months and 6 months later. Method of measurement: Periodontal probe.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-29</approval_date>
        <contact_name>Ethics committee of Esfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
