<?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>IRCT20160815029369N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of blood components on healing of extracted teeth site</public_title>
      <acronym></acronym>
      <scientific_title>Radiographic and histologic comparison of changes in  dental sockets grafted with LPRF and sockets without intervention a  randomized controlled clinical tiral  study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39721</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: with regard to simple randomization method we make 2 groups consist of test and control then we wrote them on 26 rolled paper and put them in a basket. each patient take a paper from basket and so her/his group will appear, Blinding description: The persons who analyse the radiographic image and histologic biopsy do not know about each sample group(test or control).</study_design>
      <phase>N/A</phase>
      <hc_freetext>ridge preservation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the teeth will have been extracted atraumatically with Periotome. four 10 ml tubes of blood will have been taken from patients and Leukocyte platelet fibrin will have been prepare with 2700 rpm  12 minutes protocol(Intraspine. Intralock .florida. USA). LPRF clots inserted in site of extraction and gently packed.we suture the entrance of socket with 5.0 nylon with mattress suture.we prescribe   Iboprofen 400mg tid for 2 days and Cholorhexidine mouth rinse bid for one week. after one week the suture will have been  removed. CBCT radiography will have been taken immediately after and 8 weeks later. in day of implant placement the histologic biopsy will have been obtained from site of implant placement using Trephine bur as a initial drill. Intervention 2: Intervention group:  the teeth will be extracted atraumatically with Periotome. we suture the entrance of socket with 5.0 nylon with mattress suture.we prescribe  Iboprofen 400mg tid for 2 days and Cholorhexidine mouth rinse bid for one week.after one week the suture will have been removed. CBCT radiography will have been taken immediately after and 8 weeks later. in day of implant placement the histologic biopsy will have been  obtained from site of implant placement using Trephine bur as a initial drill.</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 available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yousof Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dentistry Faculty of Tehran University of Medical Sciences, Amirababd, North Kargar street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1343856134</zip>
        <telephone>+98 21 8835 1178</telephone>
        <email>ym.mousavi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yousof Mousavi</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>ym.mousavi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient should be at least  18 years old
Lack of any systemic disease
Patient should not use any immunosuppressive drug, corton and any drug that can affect the bone metabolism
Intact socket or sockets which have less than 50% dehiscence</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Over than  25 %plaque index
Periodontitis
Pregnant women
Teeth with acute or chronic peri-apical lesions
Traumatic tooth extraction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z40.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for prophylactic surgery, unspecified</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 teeth will have been extracted atraumatically with Periotome. four 10 ml tubes of blood will have been taken from patients and Leukocyte platelet fibrin will have been prepare with 2700 rpm  12 minutes protocol(Intraspine. Intralock .florida. USA). LPRF clots inserted in site of extraction and gently packed.we suture the entrance of socket with 5.0 nylon with mattress suture.we prescribe   Iboprofen 400mg tid for 2 days and Cholorhexidine mouth rinse bid for one week. after one week the suture will have been  removed. CBCT radiography will have been taken immediately after and 8 weeks later. in day of implant placement the histologic biopsy will have been obtained from site of implant placement using Trephine bur as a initial drill.</i_keyword>
      <i_keyword>Intervention group:  the teeth will be extracted atraumatically with Periotome. we suture the entrance of socket with 5.0 nylon with mattress suture.we prescribe  Iboprofen 400mg tid for 2 days and Cholorhexidine mouth rinse bid for one week.after one week the suture will have been removed. CBCT radiography will have been taken immediately after and 8 weeks later. in day of implant placement the histologic biopsy will have been  obtained from site of implant placement using Trephine bur as a initial drill.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in ridge height and width. Timepoint: Measuring of ridge width and height  immediately and 8 weeks after extraction. Method of measurement: radiographic analysis will have been  performed on DICOM file.</prim_outcome>
      <prim_outcome>New bone formation. Timepoint: New bone formation in histologic view 8 weeks after extraction. Method of measurement: Histologic evaluation with Microbin software .</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ridge width in 25,50 and 75 % of socket depth. Timepoint: immediately after tooth extraction  and 8 weeks later. Method of measurement: evaluation on DICOM file.</sec_outcome>
      <sec_outcome>Height of buccal plate. Timepoint: immediately after tooth extraction  and 8 weeks later. Method of measurement: evaluation on DICOM file.</sec_outcome>
      <sec_outcome>Height of lingual plate. Timepoint: immediately after tooth extraction  and 8 weeks later. Method of measurement: evaluation on DICOM file.</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>2019-01-13</approval_date>
        <contact_name>the ethics committee Tehran University of Medical Sciences</contact_name>
        <contact_address>Dentistry faculty of Tehran University 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>
