<?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>IRCT2012070210155N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-07-16</date_registration>
      <primary_sponsor>Dental and Periodontal Research Center</primary_sponsor>
      <public_title>Comparison of Laser and  Chlorhexidine Gel and Treatment of gingival disease.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Evaluation of Clinical and Microbiological Effect of Subgingival Aplication of Chlorhexidine Gel and Photodynamic Therapy as an Adjunct to Full Mouth Scaling and Root Planning in Treatment of Periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10609</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: scaling and root planning: standard treatment of periodontal disease which carried out for one time by ultrasonic instruments in one of the teeth of a patient with probing depth&gt;4 mm in order to remove  plaque and calculus. Intervention 2: Subgingival chlorhexine gel is a gel form material which is consist of chlorhexidine diglocunate and chlorhexidine dihydrochloride incorporated in a adhesive carrier called xanthan.Chlorhexidine gel was applied in the pocket of theselectedl site in other quadrant of the same patient in a single dose manner. Intervention 3: Photodynamic therapy in a therapeutic method that Following the activation of the photosensitizer through light of a certain wavelength, singlet oxygen is produced that is extremely toxic to certain cells and bacteria. Tolonium Chloride was applied in the pocket of the same patient  and remained there for 60 seconds. After that tolonium chloride was irradiated by the laser with 670-690 nm wavelength and power density of 8-10 j/cm2 for 120 seconds .It was a single treatment.</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>Mohammad Taghi Chitsazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences, Golghasht street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>chitsazm@tbzmed.ac.ir</email>
        <affiliation>Department of periodontics of Dental Faculty of Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Taghi Chitsazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Periodontics of Dental Faculty of Tabriz University of Medical Sciences, Golghasht street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>chitsazm@tbzmed.ac.ir</email>
        <affiliation>Department of periodontics of Dental Faculty of Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The participants with the following inclusion criteria included in the study: modera-to-severe chronic periodontitis, no active periodontal treatment during the past 6 months, presence of at least one site per quadrant exhibiting pocket depth of ≥4 mm with bleeding on probing.&#13;
The exclusion criteria were: use of antibiotics for the past 6 months; previous periodontal surgery for the past 9 months,smoker persons; pregnant or lactating women; subjects with any systemic condition which might influence the course of periodontal disease or treatment (HIV/AIDS, uncontrolled diabetes); any active malignancy of any sort.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</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 - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>scaling and root planning: standard treatment of periodontal disease which carried out for one time by ultrasonic instruments in one of the teeth of a patient with probing depth&gt;4 mm in order to remove  plaque and calculus.</i_keyword>
      <i_keyword>Subgingival chlorhexine gel is a gel form material which is consist of chlorhexidine diglocunate and chlorhexidine dihydrochloride incorporated in a adhesive carrier called xanthan.Chlorhexidine gel was applied in the pocket of theselectedl site in other quadrant of the same patient in a single dose manner.</i_keyword>
      <i_keyword>Photodynamic therapy in a therapeutic method that Following the activation of the photosensitizer through light of a certain wavelength, singlet oxygen is produced that is extremely toxic to certain cells and bacteria. Tolonium Chloride was applied in the pocket of the same patient  and remained there for 60 seconds. After that tolonium chloride was irradiated by the laser with 670-690 nm wavelength and power density of 8-10 j/cm2 for 120 seconds .It was a single treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Probing depth. Timepoint: At baseline, one month and three month after baseline. Method of measurement: In millimetre by periodontal  probe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quantitative levels of Porphyromonas Gingivalis. Timepoint: baseline,3 month later. Method of measurement: quantitative measurement by real-time polymerase chain reaction.</sec_outcome>
      <sec_outcome>Clinical attachment level (CAL). Timepoint: Baseline, 1 month and 3 month after baseline. Method of measurement: In millimetre by periodontal  probe.</sec_outcome>
      <sec_outcome>Gingival recession (REC). Timepoint: Baseline, 1 month and 3 month later. Method of measurement: In millimetre by periodontal  probe.</sec_outcome>
      <sec_outcome>Bleeding on probing (BOP). Timepoint: Baseline, 1 month and 3 month after baseline. Method of measurement: In millimetre by periodontal probe.</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>Dental and Periodontal Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-07-10</approval_date>
        <contact_name>Ethics Committe of Tabriz University of Medical Sciences</contact_name>
        <contact_address>thics Committe of Tabriz University of Medical Sciences, Vice Chancllor for Research of Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, Golghasht street,Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
