<?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>IRCT138809282885N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-01</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Effect of surgical periodontal therapy on gingival cervicular fluid and salivary concentration of L-Plastin</public_title>
      <acronym></acronym>
      <scientific_title>Effect of surgical periodontal therapy on gingival cervicular fluid and salivary concentration of L-Plastin in patients with chronic peridontitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2757</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: In case group after oral hygiene instruction and scaling &amp; root planng after one month flap surgery will done in quadrant that needs surgery. Intervention 2: In control group no intervention will done.</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 Asieh Mozaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin Medical Science , Bahonar blvd, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981134197</zip>
        <telephone>+98 28 3323 9256</telephone>
        <email>assaiehmozaffari@yahoo.com</email>
        <affiliation>Qazvin Dental School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shadi Assareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar blvd, Qazvin</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981134197</zip>
        <telephone>+98 28 3323 9256</telephone>
        <email>drshadi.assareh@gmail.com</email>
        <affiliation>Qazvin Dental School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The control group was the people that They had no history of periodontitis ; had more than 20 teeth; They exhibited no sites with &gt; 3 mm probing pocket depth ;No sites with&gt; 1 mm clinical attachment loss; as well as no radiographic evidence of alveolar bone loss.&#13;
The chronic periodontitis group had more than 20 teeth; had probing pocket depth ≥ 5 mm &amp; clinical attachment loss of ≥ 3 mm, which was commensurate with the amount of plaque accumulation with  radiographic evidence of alveolar bone in at least two quadrant of four quadrant in which at least two teeth in each quadrant have clinical attachment loss &amp; bone loss.&#13;
Exclusion criteria:chemotherapy; pregnancy; lactation; HIV; systemic disease like respiratory &amp; cardiovascular disease; getting antibiotic &amp; other drugs within 4 months ago; getting periodontal therapy in the past.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>KO5.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pericoronitis Periodontitis: NOS complex simplex</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In case group after oral hygiene instruction and scaling &amp; root planng after one month flap surgery will done in quadrant that needs surgery.</i_keyword>
      <i_keyword>In control group no intervention will done</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>L plastin concentration. Timepoint: Baseline, one month after oral hygiene instruction &amp; scaling &amp; root planing and one month after completion  of flap surgeries. Method of measurement: Analysis done with ELIZA , picogram /ml.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Probing depth. Timepoint: Baseline, One month after oral hygiene instruction and scaling &amp; root planing and one month after completion of flap surgeries. Method of measurement: Milimeter with periodontal probe.</sec_outcome>
      <sec_outcome>Attachment loss. Timepoint: Baseline,One month after oral hygiene instruction and scaling &amp; root planing and one month after completion of flap surgeries. Method of measurement: Milimeter with periodontal probe.</sec_outcome>
      <sec_outcome>Plaque index. Timepoint: Baseline, One month after oral hygiene instruction and scaling &amp; root planing and one month after completion of flap surgeries. Method of measurement: Oraly plaque index.</sec_outcome>
      <sec_outcome>Bleeding on probing. Timepoint: Baseline, One month after oral hygiene instruction and scaling &amp; root planing and one month after completion of flap surgeries. Method of measurement: Dichotomous measurement of bleeding on probing.</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, Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-25</approval_date>
        <contact_name>Ethics Committee Qazvin Medical Science School</contact_name>
        <contact_address>Bahonar blvd, Qazvin Qazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
