<?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>IRCT20210626051717N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation effect of use PRF in maxillary sinus bone graft</public_title>
      <acronym></acronym>
      <scientific_title>Radiologic evaluation of density and height of maxillary sinus use of CBCT with and without use of PRF and biomaterials(Randomized clinical Trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study is done by simple randomization method with an individual unit so that at the beginning of each surgery in a patient the word left or right is written on the closed cans and by removing a can randomly and observing the word Right or left It is indicated that the fibrin-rich platelet sample is used in the patient's right sinus lift surgery or in left site and in the  opposite side only biomaterials are used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigation of height and density of maxillary sinus floor bone on both sides of posterior maxilla.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, patients aged 20-80 years without systemic disease with bilateral partial edentulousness or complete edentulousness whose remaining bone height behind the maxilla is less than 5 mm will be selected. Prior to sinus lift surgery, 20 to 40 mm of blood is collected from the patient's vein in sterile test tubes without anticoagulant and will be immediately centrifuged at 3000 rpm for 10 minutes. . As a result of the activation of the coagulation cascade and the formation of a three-layer fibrin network, including: the top layer of cell-free plasma or PPP, the middle layer of PRF and the bottom layer, which are red blood cells, will be visible in the test tube. The middle layer, or PRF, is cut with scissors from the red blood cell clots and will be used randomly with biomaterials on one side of the sinus space. Intervention 2: Control group: This study is performed as a split mouth, ie in each patient, one side of the sinus lift surgery is performed with PRF intervention and is classified as an intervention group, and on the opposite side, sinus lift surgery without PRF intervention is performed as a control group.In each patient, there is both an intervention group and a control group. On one side of the mouth, which uses PRF, it is placed in the intervention group, and on the opposite side of the mouth, which does not use PRF, it is classified in the control group.</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 more information. "</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rana khalafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 143. Beheshti Deadend. Gajar Alley.Hojjati street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5185737418</zip>
        <telephone>+98 41 3281 7829</telephone>
        <email>ranakhalafy@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rana Khalafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 143. Beheshti Dead end. Gajar Alley. Hojjati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5185737418</zip>
        <telephone>+98 41 3281 7829</telephone>
        <email>ranakhakafy@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 20 to 80 years old male and female without systemic disease
Bilateral partial edentulousness of posterior part of maxilla or complete edentulousness
Maxillary sinus floor bone height below 5 mm</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of uncontrolled systemic diseases
Use of immunosuppressive drugs and bisphosphonates
Head and neck radiotherapy
Presence of pathology and inflammatory diseases in maxillary sinus
Existence of active periodontal disease behind the maxilla
Irregular and chronic smoking</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: In this study, patients aged 20-80 years without systemic disease with bilateral partial edentulousness or complete edentulousness whose remaining bone height behind the maxilla is less than 5 mm will be selected. Prior to sinus lift surgery, 20 to 40 mm of blood is collected from the patient's vein in sterile test tubes without anticoagulant and will be immediately centrifuged at 3000 rpm for 10 minutes. . As a result of the activation of the coagulation cascade and the formation of a three-layer fibrin network, including: the top layer of cell-free plasma or PPP, the middle layer of PRF and the bottom layer, which are red blood cells, will be visible in the test tube. The middle layer, or PRF, is cut with scissors from the red blood cell clots and will be used randomly with biomaterials on one side of the sinus space.</i_keyword>
      <i_keyword>Control group: This study is performed as a split mouth, ie in each patient, one side of the sinus lift surgery is performed with PRF intervention and is classified as an intervention group, and on the opposite side, sinus lift surgery without PRF intervention is performed as a control group.In each patient, there is both an intervention group and a control group. On one side of the mouth, which uses PRF, it is placed in the intervention group, and on the opposite side of the mouth, which does not use PRF, it is classified in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Using and not using fibrin-rich platelets with biomaterial. Timepoint: 6 months after graft. Method of measurement: Is an independent variable that is measured in terms of use or non-use.</prim_outcome>
      <prim_outcome>Maxillary sinus floor bone density. Timepoint: 6 months after graft. Method of measurement: Hansfield number from CBCT.</prim_outcome>
      <prim_outcome>Height of maxillary sinus floor bone. Timepoint: 6 months after graft. Method of measurement: Based on millimeters from CBCT.</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>2021-12-18</approval_date>
        <contact_name>Ethics Committee of Azad University of Medical Sciences, Tabriz Branch</contact_name>
        <contact_address>Complex No. 2 of Islamic Azad University, Tabriz Branch. medical School .First Basmanj Road.Ahar three ways Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
