<?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>IRCT20190721044296N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>periimplant free gingival graft</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of dimensional changes of periimplant attached gingiva following the treatment of free gingival graft by conventional and Accordion methods; randomized clinical trial two arm parallel</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41005</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random allocation list is provided by a collaborator of the methodology and project statistics. Examination of patients for the eligibility of patients is done by the periodontist specialist of the faculty. Patients receive the questionnaire and numbered envelopes in the same order of enter to the study by the executor (resident of periodontology) and thus assigned to two treatment groups. Envelopes are opened precisely before surgery and in accordance with the surgical procedure outlined therein.</study_design>
      <phase>N/A</phase>
      <hc_freetext>mucogingival problem around implant, deficiency in thickness and width of keratinize tissue.</hc_freetext>
      <i_freetext>Intervention 1: “Intervention group one”:  For treatment with Accordian method, tissue with  60% mesiodistal length of the recipient area is provided.The graft is removed with a minimum thickness of 1.5 mm and a width of 5-7 mm and  are sutured to the recipient area. Intervention 2: Intervention group two: conventional free gingival graft.  In Conventional method graft with appropriate length (the size of the recipient site) is made.The graft is removed with a minimum thickness of 1.5 mm and a width of 5-7 mm and  are sutured to the recipient area.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niusha Namadmalian Esfahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry Faculty of Medical Sciences, Amirabad, North kargar street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1343856134</zip>
        <telephone>+98 21 8835 1178</telephone>
        <email>niusha_namadmalian@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niusha Namadmalian Esfahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry Faculty of Medical Sciences, Amirabad, North kargar street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1343856134</zip>
        <telephone>+98 21 8835 1178</telephone>
        <email>niusha_namadmalian@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>More than one implant (with min. mesiodistal length 15 mm).
The width of the keratinized tissue should be less than 2 mm.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic disease affecting periodontal conditions and wound healing
Signs of inflammation
Bleeding during probing
Secretion of pus and active infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K13.22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Minimal keratinized residual ridge mucosa</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 one”:  For treatment with Accordian method, tissue with  60% mesiodistal length of the recipient area is provided.The graft is removed with a minimum thickness of 1.5 mm and a width of 5-7 mm and  are sutured to the recipient area.</i_keyword>
      <i_keyword>Intervention group two: conventional free gingival graft.  In Conventional method graft with appropriate length (the size of the recipient site) is made.The graft is removed with a minimum thickness of 1.5 mm and a width of 5-7 mm and  are sutured to the recipient area.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Width of the keratinized tissue". Timepoint: evaluating Width of the keratinized tissue 1, 3, and 6 months after surgery. Method of measurement: As with similar studies, the reference point for measuring the width of the keratinized tissue  is gingival margin in the central region of the implant. The width of the keratinized tissue is measured by doing the roll test and measuring the distance with the Michigan Probe to the mucogingival Line.</prim_outcome>
      <prim_outcome>"Vestibular Depth". Timepoint: evaluating Vestibular Depth  1, 3, and 6 months after surgery. Method of measurement: As with similar studies, the reference point for measuring the Vestibular Depth  is gingival margin in the central region of the implant. Vestibular depth is measured by measuring the margin of the gingiva in the central region of the implant with the Michigan O probe to the depth of the vestibule.</prim_outcome>
      <prim_outcome>"probing depth". Timepoint: evaluating probing depth 1, 3, and 6 months after surgery. Method of measurement: The probing depth is measured as the penetration of the probe into the sulcus around the implant with the Michigan O probe.</prim_outcome>
      <prim_outcome>"Plaque index". Timepoint: evaluating Plaque index 1, 3, and 6 months after surgery. Method of measurement: The amount of plaque is recorded according to the Silness &amp; Loe index. In this index, the score is zero for the absence of microbial plaque, the score of one corresponding to the presence of a thin layer of plaque that is characterized by moving the probe on the margin of the free gingiva. If there is a moderate amount of plaque visible to the naked eye, it is awarded a score of 2 and if there is a large accumulation of a score of 3.</prim_outcome>
      <prim_outcome>"bleeding on probing". Timepoint: evaluating bleeding on probing 1, 3, and 6 months after surgery. Method of measurement: Bleeding during probing  is recorded as the presence or absence of bleeding during probing.</prim_outcome>
      <prim_outcome>"pain". Timepoint: Pain is measured daily after surgery until total removal of pain. Method of measurement: After surgery, the pain is recorded using a Numerical rating scale. The patient is asked to record daily pain levels until the pain is eliminated. Zero refers to the absence of pain and the number 10 refers to the worst pain experienced by the patient.</prim_outcome>
      <prim_outcome>"The amount of shrinkage". Timepoint: evaluating the amount of shrinkage 1, 3, and 6 months after surgery. Method of measurement: Ratio of Shrinkage Percentage of Keratinized Tissue Width in each Specimen at Time Intervals.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-09</approval_date>
        <contact_name>Ethics committee of Tehran University  of Medical Sciences</contact_name>
        <contact_address>Dentistry Faculty of Medical Sciences, Amirabad, North kargar street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
