<?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>IRCT201201231760N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-02-22</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of plasma rich growth factor in treatment of molar class II furcation involvement</public_title>
      <acronym></acronym>
      <scientific_title>The effect of plasma rich growth factor in treatment of molar class II furcation involvement</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/1279</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>molar class II furcation involvment.</hc_freetext>
      <i_freetext>Intervention 1: Control group: in one site treatment with double layer of membrane alone the treatment interference with drug. Intervention 2: Intervention group: Treatment with PRGF gel like in furcation area that  is covered  with double layer membrane of biogide.The preparation of PRGF gel: PRGF that 500 microliter in every tube is rich of growth factor and 4 times accumulated. Pour the Plasma in empty tube and for change it  to gel  to use it to apply space maintainer under the membrane.50 microliter with pipet 50 microliter from calcium chloride for every cc from PRGF add to sterile tube, after mixing plasma with calcium chloride, pour  it into  the sterile glassy dish and close its door.</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>Hodis Ehsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1229 1408</telephone>
        <email>Hodis_Ehsani@yahoo.com</email>
        <affiliation>Dental School, Babol</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Niloofar Jenabiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School, Babol University of Medical Sciences, Gangafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1229 1408</telephone>
        <email>Hodis_Ehsani@yahoo.com</email>
        <affiliation>Dental School, Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The patients who have moderate to severe periodontitis that have class II furcation involvement in buccal or lingual first molar or second molar in mandible; good cooperation after the primary periodontal treatment; The horizontally amount to enter the probe is &gt;3mm. Exclusion criteria: the patients who have systemic disease; the patients who need the prophylactic treatment of antibiotic for prevention of bacterial endocarditis; Smoker patient; the teeth that have anatomical complication like cervical enamel projection, bi furcation ridge concavity, accessory canal and mobility &gt;class II; The patient who uses the drugs that interact with periodontal healing, prescience of caries and filling in furcation area and presence of contra indication for periodontal surgery; the teeth in clinical view or radiography has evidence of preapical pathology; and regarding to the test performance the patient before surgery if the bleeding time and CBC is abnormal.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic periodontitis</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>Control group: in one site treatment with double layer of membrane alone the treatment interference with drug</i_keyword>
      <i_keyword>Intervention group: Treatment with PRGF gel like in furcation area that  is covered  with double layer membrane of biogide.The preparation of PRGF gel: PRGF that 500 microliter in every tube is rich of growth factor and 4 times accumulated. Pour the Plasma in empty tube and for change it  to gel  to use it to apply space maintainer under the membrane.50 microliter with pipet 50 microliter from calcium chloride for every cc from PRGF add to sterile tube, after mixing plasma with calcium chloride, pour  it into  the sterile glassy dish and close its door.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Treatment of molar class II furcation involvement. Timepoint: Six months after the start of the intervention. Method of measurement: Clinical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vertical probing depth(VPD). Timepoint: Baseline and immediately before surgery and 1 month after surgery around each tooth. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Vertical clinical att level(VCAL). Timepoint: Baseline and immediately before surgery and 1 month after surgery around each tooth. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Fonix to base of defect(FBD). Timepoint: During the first surgery and 6 months after surgery to reentry around each tooth. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Fonix to Alveolar crest(	FAC). Timepoint: During the first surgery and 6 months after surgery to reentry around each tooth. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Furcation vertical compoment (FVC). Timepoint: During the first surgery and 6 months after surgery to reentry around each tooth. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Furcation horizontal component(FHC). Timepoint: During the first surgery and 6 months after surgery to reentry around each tooth. Method of measurement: Clinical examination.</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>Vice Chancellor for Research and Technology, Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-17</approval_date>
        <contact_name>The ethics committee of Babol University of Medical sciences</contact_name>
        <contact_address>Babol University of Medical sciences, Gangafroz Avenue Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
