<?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>IRCT20180714040460N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of simultaneous use of Acellular dermal matrix and autogenous free gingival strap on formation of keratinized gingiva</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of using Acellular dermal matrix (ADM)  and autogenous free gingival strap on clinical conditions of gingiva</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>11</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38516</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The division of samples into two groups test and control was based on the type of graft technique, Randomization description: Divide the samples (each jaw) completely randomly into two groups of case and control by dropping the coin and dividing it into two groups of alloderm  (control) and alloderm and autogenous free gingival strap (case), Blinding description: All individuals involved in this research, such as clinicians, outcome evaluators, data analyzers, have been unaware of the randomization process of cases, and only researchers and operators in this study are aware of the allocation groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Insufficient keratinized gingiva.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the cases, each half-jaw was randomly assigned to the test group (the simultaneous use of the acellular dermal matrix and autogenous free gingival strap). In this group, the coronal region of receptor site was covered up to marginal margin by acellular dermal matrix called Ceno Bone from the Ceno Biologics factory with a width of 5 mm and free gingival strap was made up to a width of 2 mm from the palate and placed in the apical region of the receptor site. Intervention 2: Control group: In the cases, each half-jaw was randomly assigned to the control group (Acellular Dermal Matrix alone). In this group, the acellular dermal Matrix called Ceno Bone by the Ceno Biologics factory will be fixed at 7 mm width in the recipient area with the polyamide thread 5.0.</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:
Evaluation of using Acellular dermal matrix (ADM) and autogenous free gingival strap on clinical conditions of gingiva  in patients referring to the dental unit of Islamic Azad University of Tehran in 1397-1398 .

When:
6 months after printing the results

To whom:
All people who need data

Conditions:
Analyzes that do not damage the outcome of our data analysis are allowed.

Where to obtain:
Faculty of Dentistry Islamic Azad University of Tehran

How to obtain:
Visit the Faculty of Dentistry, Islamic Azad University of Tehran and request there, and will access the data within 1 week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nima Nadaf Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Pasdaran Street , Ninth Neyestan avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>n_nadaf@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nima nadaf Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran , Pasdaran street , Ninth Neyestan avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>n_nadaf@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient should have one to two teeth on each mandibular side with insufficient keratinized tissue (1 mm or less).
The patient should not have systemic disease diagnosed with effects on periodontal tissues.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient that does not want to cooperate on the project .
The patient with poor oral hygiene .</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: In the cases, each half-jaw was randomly assigned to the test group (the simultaneous use of the acellular dermal matrix and autogenous free gingival strap). In this group, the coronal region of receptor site was covered up to marginal margin by acellular dermal matrix called Ceno Bone from the Ceno Biologics factory with a width of 5 mm and free gingival strap was made up to a width of 2 mm from the palate and placed in the apical region of the receptor site.</i_keyword>
      <i_keyword>Control group: In the cases, each half-jaw was randomly assigned to the control group (Acellular Dermal Matrix alone). In this group, the acellular dermal Matrix called Ceno Bone by the Ceno Biologics factory will be fixed at 7 mm width in the recipient area with the polyamide thread 5.0.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Loe and Silness plaque index. Timepoint: At the begining and 3 months. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Loe and Silness gingival index. Timepoint: At the begining and 3 months. Method of measurement: Observation and probing.</prim_outcome>
      <prim_outcome>Keratinized gingiva width. Timepoint: At the begining and 3 months. Method of measurement: Periodontal probe.</prim_outcome>
      <prim_outcome>Attached gingiva width. Timepoint: At the begining and 3 months. Method of measurement: Periodontal probe.</prim_outcome>
      <prim_outcome>Probing depth. Timepoint: At the begining and 3 months. Method of measurement: Periodontal probe.</prim_outcome>
      <prim_outcome>Shrinkage percentage. Timepoint: 3 months. Method of measurement: Periodontal probe.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-13</approval_date>
        <contact_name>Faculty of Dentistry Islamic Azad University, Tehran Branch</contact_name>
        <contact_address>Pasdaran Street, Ninth Neyestan Avenue Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
