<?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>IRCT201709211081N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-02</date_registration>
      <primary_sponsor>Private clinic, Dr. Golpar Radafshar, associate professor of periodontology, Guilan University of Me</primary_sponsor>
      <public_title>How periodontal treatment affects oral health-related quality of life in patients with chronic periodontitis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of one-stage full mouth disinfection versus periodontal surgery on oral health-related quality of life in patients with chronic periodontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/102</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The original OHIP-49 questionnaire was validated and standardized for Iranian population using CVI and CVR. Some questions did not meet the appropriate CVI or CVR and were deleted. The resultant questionnaire with 35 items was used in this study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Non-surgical periodontal treatment based on Quirynen protocol of one stage full mouth disinfection comprised of scaling and root planing with Chx 0.2%  pocket irrigation completed within 24 hours. Intervention 2: Surgery comprised of flap debridement with minor osseous surgery on a quadrant basis over single or multiple treatment episodes, according patient’s treatment needs. In case of multiple sessions, a minimum of 2-week interval was considered.</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>Nastaran Mirfarhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan University of Medical Sciences complex, Professor Samiee Blv. Gaz square</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4194173774</zip>
        <telephone>+98 13 3326 3616</telephone>
        <email>mirfarhadin@gmail.com</email>
        <affiliation>Dental Sciences Research Center, Dental Faculty, Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Golpar Radafshar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan University of Medical Sciences complex, Professor Samiee Blv. Gaz square</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4194173774</zip>
        <telephone>+98 13 3326 3616</telephone>
        <email>golshad@gums.ac.ir/ or/ golishad@gmail.com</email>
        <affiliation>Department of Periodontology, Dental Faculty, Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were a diagnosis of generalized moderate to severe chronic periodontitis and having at least 20 standing teeth. The exclusion criteria were a history of periodontal treatment 6 months prior to entry, taking any medication known to affect periodontal tissues, taking anti-depressant, anti-anxiety, anti-inflammatory, and immunosuppressive medications, uncontrolled diabetes, pregnancy or lactation, smoking, and needing antibiotic prophylaxis.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 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 - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Non-surgical periodontal treatment based on Quirynen protocol of one stage full mouth disinfection comprised of scaling and root planing with Chx 0.2%  pocket irrigation completed within 24 hours.</i_keyword>
      <i_keyword>Surgery comprised of flap debridement with minor osseous surgery on a quadrant basis over single or multiple treatment episodes, according patient’s treatment needs. In case of multiple sessions, a minimum of 2-week interval was considered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral health-related quality of life. Timepoint: Baseline, after non-surgical, after surgical intervention. Method of measurement: Validated Iranian version of the Oral health impact profile questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Periodontal pocket depth. Timepoint: Baseline, after non-surgical, after surgical interventions. Method of measurement: Using a periodontal probe, distance from gingival margin to the base of the pocket is measured.</sec_outcome>
      <sec_outcome>Clinical attachment level. Timepoint: Baseline, after non-surgical, after surgical interventions. Method of measurement: Using a periodontal probe, distance from a fix point to the base of pocket is measured.</sec_outcome>
      <sec_outcome>Bleeding on probing. Timepoint: Baseline, after non-surgical, after surgical interventions. Method of measurement: Lenox &amp; Kopczyk bleeding index.</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>Private clinic, Dr. Golpar Radafshar, associate professor of periodontology, Guilan University of Me</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-26</approval_date>
        <contact_name>Guilan University of Medical Sciences</contact_name>
        <contact_address>School of health old building, opposite 17 Shahrivar hospital, Siadati street, Namjoo road Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
