<?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>IRCT20180416039329N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-24</date_registration>
      <primary_sponsor>معاونت پژوهشی دانشکده دندانپزشکی شهید بهشتی</primary_sponsor>
      <public_title>comparison of histologic, clinical and radiographic results of  post extraction ridge preservation using xenogenic bone material with/without A-PRF</public_title>
      <acronym>A-PRF=Advanced platelet rich fibrin</acronym>
      <scientific_title>comparison of histologic, clinical and radiographic results of  post extraction ridge preservation using xenogenic bone material with/without A-PRF</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31883</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: random allocation software was used for simple randomization. after allocation in 2 groups with 10 participants, concealed in sequentially numbered, sealed, opaque envelopes were used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>ridge preservation-xenograft-Bio-Oss-PRF.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Bio-Oss group: CBCT radiography is taken. after optimum local anesthesia, tooth is extracted using less traumatic approach and minimum reflection of the flap. Bio-Oss is prepared with conventional method and is applied to overfill the socket. Bio-Gide membrane is used to cover the socket completely. flap is sutured with 4-0 vicryl and figure of 8 technique. 3 month later CBCT radiography is taken again, Biopsy is harvested before the implant placement. Intervention 2: Intervention group: Bio-Oss + A-PRF group: CBCT radiography is taken. after optimum local anesthesia, tooth is extracted using less traumatic approach and minimum reflection of the flap. Bio-Oss is mixed with A-PRF (by centrifuging the patient's blood) and is applied to overfill the socket. Bio-Gide membrane is used to cover the socket completely. flap is sutured with 4-0 vicryl and figure of 8 technique. 3 month later CBCT radiography is taken again, Biopsy is harvested before the implant placement.</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:
all information is accessable

When:
after publication

To whom:
all related fields

Conditions:
bailment principles

Where to obtain:
arminmirfasihi@yahoo.com

How to obtain:
sending request via email-evaluate-sending the information(1 month)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Armin mirfasihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 30-takhti street-fershteh street-vali asr ave.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1965745411</zip>
        <telephone>+98 21 2203 5411</telephone>
        <email>arminmirfasihi@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Armin Mirfasihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>velenjak ave. chamran highway</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2217 5351</telephone>
        <email>arminmirfasihi@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>aged over 18 years
Periodontal health
Healthy patients and ASAs 1 and 2, according to the American Cancer Society Association's classification system
absence of any infection or periapical lesion
Bone conditions such that at least 50% of the bone support remains after the tooth is extracted.(Necessity of Radiographic evaluation before surgery)
absence of any uncontrolled systemic disease that complicates the healing process, such as uncontrolled diabetes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with ASA III status or above
presence of any uncontrolled systemic disease that complicatesthe the healing process, such as uncontrolled diabetes
smoker
Use of immunosuppressive drugs
Radiotherapy history
pregnancy
Removable prosthesis in the treatment area or adjacent to the dental socket area
spreading infection adjacent to the target area</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>Control group: Bio-Oss group: CBCT radiography is taken. after optimum local anesthesia, tooth is extracted using less traumatic approach and minimum reflection of the flap. Bio-Oss is prepared with conventional method and is applied to overfill the socket. Bio-Gide membrane is used to cover the socket completely. flap is sutured with 4-0 vicryl and figure of 8 technique. 3 month later CBCT radiography is taken again, Biopsy is harvested before the implant placement.</i_keyword>
      <i_keyword>Intervention group: Bio-Oss + A-PRF group: CBCT radiography is taken. after optimum local anesthesia, tooth is extracted using less traumatic approach and minimum reflection of the flap. Bio-Oss is mixed with A-PRF (by centrifuging the patient's blood) and is applied to overfill the socket. Bio-Gide membrane is used to cover the socket completely. flap is sutured with 4-0 vicryl and figure of 8 technique. 3 month later CBCT radiography is taken again, Biopsy is harvested before the implant placement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bone height. Timepoint: base time- 3 month. Method of measurement: CBCT (radiographic evaluation).</prim_outcome>
      <prim_outcome>Bone width. Timepoint: base time- 3 month. Method of measurement: CBCT (radiographic evaluation).</prim_outcome>
      <prim_outcome>Ratio of 1-new bone formation to 2-remnant particles to 3-other non mineralized tissues. Timepoint: base time- 3 month. Method of measurement: histologic examination.</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>معاونت پژوهشی دانشکده دندانپزشکی شهید بهشتی</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-12</approval_date>
        <contact_name>ethics committee of shahid beheshti university of medial sciences</contact_name>
        <contact_address>velenjak ave. chamran highway tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
