<?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>IRCT20171015036782N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-27</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation  the effect of Simvastatin and platelets rich fibrin in the socket of extracted teeth.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the quality of formed bone and pain after use of platelet rich fibrin (PRF) and Simvastatin in the extracted tooth socket</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>19</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomizing the samples is done using a table of random numbers. In order to hide the random allocation, the method of using a non-transparent sealed envelope is also used. In this way, two envelopes are prepared with aluminum fibers (in order to make the contents of the envelopes unclear) and each of the random intervention methods is recorded on a card and the cards are placed inside the envelopes in order. At the start of the intervention, based on the order of the intervention, one of the letter envelopes is opened and its assigned group is revealed, Blinding description: In this study, the participants will not be aware of the type of prescribed drug.</study_design>
      <phase>3</phase>
      <hc_freetext>Loss of teeth due to accident, extraction or local periodontal disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Platelet-rich fibrin extracted from 40 cc of the patient's own blood, topically in extracted tooth socket.The blood extracted from the patient is immediately placed in a centrifuge and after separating the platelets rich fibrin (PRF) along with absorbable collagen, placed in the dental socket. Intervention 2: Intervention group: Simvastatin 20 mg manufactured by Tehran Chemical Company with the brand name Sivesterol 20, topically in extracted tooth socket. Simvastatin is powdered and then placed inside the socket of the extracted tooth by absorbable collagen.</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:
Data sets used and/or analyzed during the present study are available from the corresponding author upon request.

When:
The access period starts 6 months after the results are published.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Data sets used and/or analyzed during the present study are available from the corresponding author upon request.

Where to obtain:
In order to receive data/documents, you can contact the author of this study through the e-mail address faridf2171@gmail.com.

How to obtain:
By sending an email to the responsible author and explaining about the applicant's project proposal and how to use the information, the requested information will be available to the applicant after 10 days after approval by the responsible author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faridoddin Fani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916147860</zip>
        <telephone>+98 35 3830 1323</telephone>
        <email>faridf2171@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faridoddin Fani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916147860</zip>
        <telephone>+98 35 3830 1323</telephone>
        <email>faridf2171@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 20 to 65 years old
candidate for implant insertion of both sides of a jaw
two similar hopeless tooth of both sides of a jaw</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Smoking
Using immunosuppressive medications
Uncontrolled diabetes
Systemic disease
History of radiotherapy
Allergy
Periodontal disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K08.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complete loss of teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Platelet-rich fibrin extracted from 40 cc of the patient's own blood, topically in extracted tooth socket.The blood extracted from the patient is immediately placed in a centrifuge and after separating the platelets rich fibrin (PRF) along with absorbable collagen, placed in the dental socket.</i_keyword>
      <i_keyword>Intervention group: Simvastatin 20 mg manufactured by Tehran Chemical Company with the brand name Sivesterol 20, topically in extracted tooth socket. Simvastatin is powdered and then placed inside the socket of the extracted tooth by absorbable collagen.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of vital bone. Timepoint: 3 months after tooth extraction at the time of the implant surgery, samples will be taken. Method of measurement: light microscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: 1 and 7 days after the extractions, pain will be measured. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Non-vital bone. Timepoint: 3 months after tooth extraction at the time of the implant surgery, samples will be taken. Method of measurement: light microscope.</sec_outcome>
      <sec_outcome>Percentage of amorphous bone. Timepoint: 3 months after tooth extraction at the time of the implant surgery, samples will be taken. Method of measurement: light microscope.</sec_outcome>
      <sec_outcome>Percentage of trabecular bone. Timepoint: 3 months after tooth extraction at the time of the implant surgery, samples will be taken. Method of measurement: light microscope.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-31</approval_date>
        <contact_name>Ethics committee of yazd University of Medical Sciences</contact_name>
        <contact_address>No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
