<?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>IRCT20190429043413N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-29</date_registration>
      <primary_sponsor>directorate of Health, Rescue and Treatment of Police Headquarter of Islamic Republic of Iran</primary_sponsor>
      <public_title>platelet-rich plasma (PRP) in mandibular condyle fractures</public_title>
      <acronym>PRP</acronym>
      <scientific_title>Assessing of the use of platelet-rich plasma (PRP) in improving function and healing in the treatment of mandibular condyle fractures by the closed reduction In traumatized patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72240</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: in this study, random allocation software was used for simple randomization. after allocation in 2 groups with 32 persons, concealed in sequentially numbered, sealed, opaque envelopes, Blinding description: Participants , after choose of one sealed envelopes, place on one of groups and because of doing procedure under general anesthesia,  they don't have any information about PRP injection into the fracture site. Also, evaluators don't know what is the group of any patient and PRP injection. Data analyzer analysis data without any information about groups.</study_design>
      <phase>3</phase>
      <hc_freetext>mandibular condyle fracture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in this group, PRP is injected into the fracture area. Patients in intervention group, underwent arch bar insertion under general anesthesia. then, 10cc venal blood is taken and PRP is extracted. About 2 cc of PRP is injected into the fracture area( palpitation of joint for detect the injection position). for 2-4 weeks, patients have MMF. Intervention 2: Control group: no intervention, just usual fracture treatment. Under general anesthesia, arch bar is inserted and then for 2-4 weeks patients have MMF.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pedram Bakhshaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>dental faculty, Daneshjoo blv, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2217 5350</telephone>
        <email>bakhshaei.pedram@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pedram Bakhshaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>dental faculty, Daneshjoo blv, Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2217 5350</telephone>
        <email>bakhshaei.pedram@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with at least 18 years old
patients who need close reduction of condylar fractures
stable and repeatable occlusion for maxillomandibular fixation(MMF)
patients without any bone disorders like arthritis
no history of bisphosphonate use</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>unstable occlusion for MMF
condylar displacement into cranial fossa
extracapsular displacement
contraindication for MMF like seizure of intolerance of patients
metabolic bone disorders or arthritis
use of medications that affect on bone metabolism
open reduction and internal fixation of fractures
inability to follow up the patients
growing patients
history of jaw or condylar surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S02.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of mandible</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in this group, PRP is injected into the fracture area. Patients in intervention group, underwent arch bar insertion under general anesthesia. then, 10cc venal blood is taken and PRP is extracted. About 2 cc of PRP is injected into the fracture area( palpitation of joint for detect the injection position). for 2-4 weeks, patients have MMF.</i_keyword>
      <i_keyword>Control group: no intervention, just usual fracture treatment. Under general anesthesia, arch bar is inserted and then for 2-4 weeks patients have MMF</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain assessment. Timepoint: the day after surgery, immediately after MMF removal. Method of measurement: based on visual analogue scale (VAS).</prim_outcome>
      <prim_outcome>Maximum mouth opening. Timepoint: before treatment, immediately after MMF removal, 2 weeks after MMF removal. Method of measurement: inter incisal distance in millimeters.</prim_outcome>
      <prim_outcome>Laterusive movement of jaw. Timepoint: before treatment, immediately after MMF removal, 2 weeks after MMF removal. Method of measurement: maxillary and mandibular dental midline displacement in laterusive movement in millimeters.</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>directorate of Health, Rescue and Treatment of Police Headquarter of Islamic Republic of Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-06</approval_date>
        <contact_name>Ethics committee of directorate of health, rescue and treatment of police headquarter of Iran</contact_name>
        <contact_address>Edward Brown st. ,North Kargar st. , Enghelab sq. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
