<?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>IRCT20180329039159N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-05</date_registration>
      <primary_sponsor>University of Palermo</primary_sponsor>
      <public_title>Effect of PRP to prevent MRONJ after dental extraction</public_title>
      <acronym></acronym>
      <scientific_title>Effect of platelet-rich plasma (PRP) on dental extraction in patients at risk of medication related osteonecrosis of the jaw</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40369</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>medication related osteonecrosis of the jaw.</hc_freetext>
      <i_freetext>Intervention group; the surgical protocol expected: 1) Chlorhexidine 0,2% mouthwashes 30 ml swished up to 60 seconds; 2)  local anesthesia achieved using 3% mepivacaine hydrochloride without adrenaline; 3) elevation of a full-thickness mucoperiosteal flap; 4) tooth luxation and avulsion were gently performed with elevators and forceps; 5) if necessary, osteoplasty 6) debridement of the post-extraction socket with miller surgical curette and irrigation of the sockets with rifamycin sodium; 7) application of a single dosage of autologous platelet-rich plasma (Plateltex ACT System ®, Biomed, Modena, IT) ; 8) tension-free soft tissue closure. To prepare the PRP and to induce its gelation, the materials provided by the manufacturer were used and the provided instructions followed [Mazzucco L, Balbo V, Cattana E, Borzini P. Platelet-rich plasma and plateletgel preparation using Plateltex. Vox Sang. 2008 Apr;94(3):202-8.].</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Giuseppina Campisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>129 Via del Vespro</address>
        <city>Palermo</city>
        <country1>Italy</country1>
        <zip>90127</zip>
        <telephone>+39 091 655 2236</telephone>
        <email>campisi@odonto.unipa.it</email>
        <affiliation>University of Palermo</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rodolfo Mauceri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 Via Benedetto Civiletti</address>
        <city>Palermo</city>
        <country1>Italy</country1>
        <zip>90141</zip>
        <telephone>+39 091 655 2221</telephone>
        <email>rodolfo.mauceri@unipa.it</email>
        <affiliation>University of Palermo</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Italy</country2>
    </countries>
    <criteria>
      <inclusion_criteria>metabolic bone disease and/or malignant tumors
treatment with bisphosphonates because of the underlying disease
required tooth extraction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>clinical or radiological signs of medication related osteonecrosis of the jaw in the surgical area
previous history of irradiation to the head and neck area
neoplastic involvement of the jaws
poor general conditions
pregnant or breast-feeding women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>m87.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteonecrosis due to drugs</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group; the surgical protocol expected: 1) Chlorhexidine 0,2% mouthwashes 30 ml swished up to 60 seconds; 2)  local anesthesia achieved using 3% mepivacaine hydrochloride without adrenaline; 3) elevation of a full-thickness mucoperiosteal flap; 4) tooth luxation and avulsion were gently performed with elevators and forceps; 5) if necessary, osteoplasty 6) debridement of the post-extraction socket with miller surgical curette and irrigation of the sockets with rifamycin sodium; 7) application of a single dosage of autologous platelet-rich plasma (Plateltex ACT System ®, Biomed, Modena, IT) ; 8) tension-free soft tissue closure. To prepare the PRP and to induce its gelation, the materials provided by the manufacturer were used and the provided instructions followed [Mazzucco L, Balbo V, Cattana E, Borzini P. Platelet-rich plasma and plateletgel preparation using Plateltex. Vox Sang. 2008 Apr;94(3):202-8.]</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Absence of signs related to MRONJ (Healing). Timepoint: We scheduled follow-up visits to remove the suture seven days after surgery, and visited patients on the fifteenth day, and continued on month one, three, six and twelve. Method of measurement: Clinical and radiological signs.</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>University of Palermo</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-10</approval_date>
        <contact_name>Palermo Ethics Committee 1</contact_name>
        <contact_address>129 Via del Vespro Palermo Sicily Italy</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
