<?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>IRCT201512251760N44</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-23</date_registration>
      <primary_sponsor>Vice chancellor for Research, Babol University of Medical Sciences</primary_sponsor>
      <public_title>Assessment of the effect of photodynamic therapy on treatment of moderate-to-severe periodontitis</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effect of photodynamic therapy on treatment of moderate-to-severe periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1308</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Groups based on all parameters (including PPD, CAL, BOP and plaque index) and with regard to the inclusion and exclusion criteria will be mentioned in the same building. All calculations weeks, third, sixth and twelfth after treatment by a clinicians will no longer do. Blindness study done.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Control  groups:&#13;
 This group will be  under scaling/root planting (SRP) treatment. Intervention 2: Intervention group 1:    &#13;
In this group, Photo-dynamic Therapy will be used. Intervention 3: Intervention group 2:&#13;
  A combination of Photodynamic Therapy and SRP will be used in this group. Treatment processes of Photodynamic Therapy will be done immediately after SRP. The light-sensitive material used in the study (manufacturer: CMS Dental, Denmark) contains 10 milligrams per milliliter methylene Blue (16, 18, and 19) that will be directly applied inside the periodontal pockets for at least 60 seconds. Then, using PhotoSan system (manufactured by the same company) and by means of a 15-mm perio-tip located inside each periodontal pocket, all surfaces of the tooth are exposed for at least 30 seconds and the pocket is rinsed. Given the uniform distribution of light in this system, it will be possible to distribute it throughout the periodontal pockets.</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>Dr. Ida Mirzaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental College, Babol University of Medical Sciences, Ganjafrooz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3229 1408</telephone>
        <email>ida.mirzaee65@gmail.com</email>
        <affiliation>Dental College of Babol</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Babak Amoian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental College, Babol University of Medical Sciences, Ganjafroz Avenue</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3229 1408</telephone>
        <email>amoian@perio.org</email>
        <affiliation>Dental College of Babol</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age older than 18 years old; having at least 20 teeth in the mouth; having at least one area with probing depth of four millimeters in at least two quadrants of the mouth (with bleeding on probing light); the plaque index, less than thirty percent.&#13;
Exclusion criteria: pregnancy; received scaling and root planing procedures or antibiotic therapy in the last six months؛ systemic disease affecting periodontal health; smoking.</inclusion_criteria>
      <agemin>18 years</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>N/A</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control  groups:&#13;
 This group will be  under scaling/root planting (SRP) treatment.</i_keyword>
      <i_keyword>Intervention group 1:    &#13;
In this group, Photo-dynamic Therapy will be used.</i_keyword>
      <i_keyword>Intervention group 2:&#13;
  A combination of Photodynamic Therapy and SRP will be used in this group. Treatment processes of Photodynamic Therapy will be done immediately after SRP. The light-sensitive material used in the study (manufacturer: CMS Dental, Denmark) contains 10 milligrams per milliliter methylene Blue (16, 18, and 19) that will be directly applied inside the periodontal pockets for at least 60 seconds. Then, using PhotoSan system (manufactured by the same company) and by means of a 15-mm perio-tip located inside each periodontal pocket, all surfaces of the tooth are exposed for at least 30 seconds and the pocket is rinsed. Given the uniform distribution of light in this system, it will be possible to distribute it throughout the periodontal pockets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Probing pocket depth. Timepoint: A week after the start of the study and at weeks three, six and twelve after treatment. Method of measurement: Clinical.</prim_outcome>
      <prim_outcome>Clinical attachment level. Timepoint: A week after the start of the study and at weeks three, six and twelve after treatment. Method of measurement: Clinical.</prim_outcome>
      <prim_outcome>Bleeding on probing(BOP). Timepoint: A week after the start of the study and at weeks three, six and twelve after treatment. Method of measurement: Clinical.</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>Vice chancellor for Research, Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-06</approval_date>
        <contact_name>Ethics committee of Babol University of Medical sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganjafroz Avenu Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
