<?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>IRCT20130813014350N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-24</date_registration>
      <primary_sponsor>Dental Research Centre, Guilan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of injectable platelet-rich fibrin in post-operative healing after tooth crown lengthening surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of injectable platelet-rich fibrin in post-operative healing after tooth crown lengthening surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43273</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The permutation block method is used to randomize treatments.
Considering blocks of 4, respectively, people will be included in the study if A receives treatment on the right and B receives treatment on the left and the other is considered as control:
Seed: 272654992542016
Block sizes: 4
Actual list length: 16
block identifier, block size, sequence within block, treatment, code
• 1, 4, 1, Group A, ZN6
• 1, 4, 2, Group A, AA8
• 1, 4, 3, Group B, ZR9
• 1, 4, 4, Group B, TS5
• 2, 4, 1, Group A, PG3
• 2, 4, 2, Group A, ZS4
• 2, 4, 3, Group B, ZQ3
• 2, 4, 4, Group B, DG0
• 3, 4, 1, Group A, JR0
• 3, 4, 2, Group B, GS3
• 3, 4, 3, Group A, KG1
• 3, 4, 4, Group B, HQ6
• 4, 4, 1, Group A, RR5
• 4, 4, 2, Group B, FA1
• 4, 4, 3, Group B, KG7
• 4, 4, 4, Group A, ER9, Blinding description: The research will be conducted in single blinded manner. To blind the patient, the researcher performs all operations on the intervention side during surgery on the control side only at the time of i-PRF injection but does not inject the insulin needle.</study_design>
      <phase>3</phase>
      <hc_freetext>Evaluation of injectable platelet-rich fibrin in post-operative healing after tooth crown lengthening surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Gingival surgery to increase the length of the crown and in order to, injecting 1 cc of i-PRF ( from 10 cc of the patient's blood in the centrifuge device (DR. CHOUKROUN DUO QUATTRO PRF CENTRIFUGE) speed  700 rpm for 3 minutes And the clear part of the fluid above the tube (i-PRF) with the insulin syringe stretched) in the patient's gums.Clinical postoperative examinations and photographic imaging are performed using the Visual Analogue Index as the primary outcome and the Early Healing Index scale as the secondary outcome on days 2, 4, 7, 10, and 14. Intervention 2: Control group: Gingival surgery in order to increase the length of the tooth crown without injecting any substance was performed .Clinical postoperative examinations and photographic imaging are performed using the Visual Analogue Index as the primary outcome and the Early Healing Index scale as the secondary outcome on days 2, 4, 7, 10, and 14.</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 injectable platelet-rich fibrin in post-operative healing after tooth crown lengthening surgery among patients referred to periodontal department of Guilan dentistry Faculty

When:
Access time 6 months after publishing the results

To whom:
Researchers working in academic institutions

Conditions:
Researchers working in academic institutions

Where to obtain:
Bardia@gums.ac.ir

How to obtain:
2 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bardia Vadiati Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4188794755</zip>
        <telephone>+98 13 1326 3622</telephone>
        <email>bardia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bardia Vadiati Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4194173774</zip>
        <telephone>+98 13 1326 3622</telephone>
        <email>bardia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients need surgery for maxillary bilateral crown lengthening including canine and premolar teeth
Patients over 18 years
Lack of systemic disease that affects wound healing
No history of surgery in the area of operation
Non-smoker
Non-pregnancy and lactation
Not using antibiotics in the last 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Coagulation Disorders
Uncooperative patient
Any complications that interfere with the postoperative recovery process and postoperative pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Gingival surgery to increase the length of the crown and in order to, injecting 1 cc of i-PRF ( from 10 cc of the patient's blood in the centrifuge device (DR. CHOUKROUN DUO QUATTRO PRF CENTRIFUGE) speed  700 rpm for 3 minutes And the clear part of the fluid above the tube (i-PRF) with the insulin syringe stretched) in the patient's gums.Clinical postoperative examinations and photographic imaging are performed using the Visual Analogue Index as the primary outcome and the Early Healing Index scale as the secondary outcome on days 2, 4, 7, 10, and 14.</i_keyword>
      <i_keyword>Control group: Gingival surgery in order to increase the length of the tooth crown without injecting any substance was performed .Clinical postoperative examinations and photographic imaging are performed using the Visual Analogue Index as the primary outcome and the Early Healing Index scale as the secondary outcome on days 2, 4, 7, 10, and 14.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Surgical Pain. Timepoint: 2,4,7,10,14 days. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Tissue repair. Timepoint: 2,4,7,10,14 days. Method of measurement: Early healing index.</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>Dental Research Centre, Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-06</approval_date>
        <contact_name>Ethics committee of guilan University of Medical Sciences</contact_name>
        <contact_address>Bustan Mellat, Ahmadzadeh Blvd., Shahid Amini Alley, Parvaneh dead end, No. 103, Rose Building Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
