<?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>IRCT2017102537002N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-14</date_registration>
      <primary_sponsor>None</primary_sponsor>
      <public_title>Evaluating a protocol of antibiotic prophylaxis to reduce bacterial contamination of the bone particles collected directly from the burs used for preparation of the dental implant site</public_title>
      <acronym>*</acronym>
      <scientific_title>The role of antibiotic prophylaxis in reducing bacterial contamination of autologous bone graft collected from implant site</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27496</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Although the patients are randomly allocated to the Test and Control groups, the study does not aim to evaluate any effects on health outcomes. The physiologically occurring bacterial contamination of bone particles produced during the preparation of the implant site does not represent a “health outcome” sensu stricto. Moreover, only a minimal part of the study is conducted in a clinical setting (the collection of bone particles during the implant site preparation), while the core of the study is performed in a laboratory setting. The operator performing surgical procedures and  collection of bone particles, the laboratory workers assessing the microbiological outcomes, and authors involved in organizing and managing the analysis of data will be blinded to group assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bacterial contamination of autologous bone particles collected from dental implant site.</hc_freetext>
      <i_freetext>Intervention 1: TEST Intervention: Antibiotic prophylaxis is prescribed to the Test group patients. One 1 gr. tablet of amoxicillin + clavulanic acid (Augmentin, GlaxoSmithKline, Verona, Italy) is given to the test group patients 12 hours and 1 hour before the surgery. All patients (Test and Control groups) will undergo the same surgical procedure (ie, implant site preparation). After local anesthesia, a full-thickness flap is made and the implant site is prepared with calibrated drills at 600 revolutions per minute, irrigated by cooled saline solution. During each step of the calibrated drills, bone particles on the coils are collected and placed in a 15 ml sterile tube containing 10 ml of prereduced thioglycolate broth. The collected samples are sent to the microbiology laboratory within one hour. Intervention 2: CONTROL Intervention: The Control group patients do not take antibiotic prophylaxis at all (No intervention). All patients (Test and Control groups) will undergo the same surgical procedure (ie, implant site preparation). It is described in the “TEST intervention” field.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Giuseppe Pizzo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Via del Vespro 129 (Plesso di Odontostomatologia)</address>
        <city>Palermo</city>
        <country1>Italy</country1>
        <zip>90127</zip>
        <telephone>00390916552221</telephone>
        <email>giuseppe.pizzo@unipa.it</email>
        <affiliation>University of Palermo</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Giuseppe Pizzo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Via del Vespro 129 (Plesso di Odontostomatologia)</address>
        <city>Palermo</city>
        <country1>Italy</country1>
        <zip>90127</zip>
        <telephone>00390916552221</telephone>
        <email>giuseppe.pizzo@unipa.it</email>
        <affiliation>University of Palermo</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Italy</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The study is conducted in healthy human volunteers. &#13;
Inclusion criteria: a need to replace the absence of one tooth with an implant supported prosthesis, no systemic diseases or contraindications to surgical procedures, no pregnancy, no routine drug use, no history of antibiotic therapy for 6 months prior to the study, no allergy to penicillin or related drugs, absence of carious lesions and local active inflammatory conditions or chronic/aggressive periodontits, presence of alveolar ridges of class II or III of Cawood and Howell (1988).&#13;
Exclusion criteria: systemic diseases that affect jaws and periodontium; orthodontic appliance; active dental caries; chronic diseases of the oral mucosa; chronic antibiotic usage; antiplaque mouthrinse consumption; drugs consumption which affect saliva flow rate; radiotherapy history.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>TEST Intervention: Antibiotic prophylaxis is prescribed to the Test group patients. One 1 gr. tablet of amoxicillin + clavulanic acid (Augmentin, GlaxoSmithKline, Verona, Italy) is given to the test group patients 12 hours and 1 hour before the surgery. All patients (Test and Control groups) will undergo the same surgical procedure (ie, implant site preparation). After local anesthesia, a full-thickness flap is made and the implant site is prepared with calibrated drills at 600 revolutions per minute, irrigated by cooled saline solution. During each step of the calibrated drills, bone particles on the coils are collected and placed in a 15 ml sterile tube containing 10 ml of prereduced thioglycolate broth. The collected samples are sent to the microbiology laboratory within one hour.</i_keyword>
      <i_keyword>CONTROL Intervention: The Control group patients do not take antibiotic prophylaxis at all (No intervention). All patients (Test and Control groups) will undergo the same surgical procedure (ie, implant site preparation). It is described in the “TEST intervention” field.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction of bacterial contamination. Timepoint: Following end of treatment (antibiotic prophylaxis), during implant site preparation. Method of measurement: Counts (CFU) and identification of isolated bacteria.</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>None</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-21</approval_date>
        <contact_name>Comitato Etico Palermo 1</contact_name>
        <contact_address>A.O.U. Policlinico Paolo Giaccone, Via del Vespro 129 Palermo PA Italy</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
