<?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>IRCT20161106030744N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-21</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of non-surgical periodontal treatment  on disease activity in patients with ankylosing spondylitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of non-surgical periodontal treatment  on disease activity in patients with ankylosing spondylitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71825</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: First, random blocks of eight containing four letters A, B, C, D (each letter is repeated twice) are generated, such as ABBDCACD.
Then, among these 8 blocks, 12 blocks are randomly selected and a sequence of 96 is created, and each letter is placed in a sealed envelope, numbered from 1 to 96. These envelopes, which contain one of the letters A, B, C, D, are delivered by the rheumatologist to the qualified people. Only the generator of the random sequence of 96 knows about the contents of the envelopes. Patients go to the dental clinic with the envelopes and hand over the envelopes to the periodontist. People who have the letter A will be assigned to the first group and the letter B will be assigned to the second group and so on.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Periodontal disease - ankylosing spondylitis.</hc_freetext>
      <i_freetext>The first group: patients with AS and PD who take non-steroidal anti-inflammatory drugs (NSAID) who will receive non-surgical periodontal intervention including SRP. The second group: patients with AS and PD who take anti-tumor necrosis factor (TNF) drugs (with or without NSAID) who will receive non-surgical periodontal intervention including SRP.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Elham Fakhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>gorgan-in front of Edalat 97-dentistry clinic of golestan university of medical science</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>49169-53363</zip>
        <telephone>+98 17 3255 0700</telephone>
        <email>Dr.fakhari@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Elham Fakhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>gorgan-in front of Edalat 97-dentistry clinic of golestan university of medical science</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>49169-53363</zip>
        <telephone>+98 17 3255 0700</telephone>
        <email>Dr.fakhari@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 years of age or older
Confirmed diagnosis of active AS by a rheumatologist
Moderate to severe generalized chronic periodontitis
Patients who have at least 20 teeth</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Antibiotic use in a period of 3 months before the study
Received non-surgical periodontal treatment in the last 6 months
smoking
Severe liver or kidney failure
Uncontrolled diabetes
Heart disease
History of radiation therapy or chemotherapy
Taking drugs with a possible effect on the periodontium (such as cyclosporine, phenytoin, calcium channel blockers)
Severe dry mouth
Pregnancy and breastfeeding
Patients who do not return to measure the investigated variables in the sixth and twelfth weeks</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z40-Z54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>افرادی که برای رویه ها و مراقبت های بهداشتی خاص با خدمات بهداشتی مواجه می شوند</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group: patients with AS and PD who take non-steroidal anti-inflammatory drugs (NSAID) who will receive non-surgical periodontal intervention including SRP. The second group: patients with AS and PD who take anti-tumor necrosis factor (TNF) drugs (with or without NSAID) who will receive non-surgical periodontal intervention including SRP</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bath Ankylosing Spondylitis Disease Activity(BASDAI). Timepoint: 0_ 12 weeks after the intervention. Method of measurement: The BASDAI consists of a 0-10 scale (0 being no problem and 10 being the worst problem) that is used to answer 6 questions related to the 5 main AS symptoms.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Periodontal indices (PI, GI, PPD, GBI, CAL). Timepoint: 0_ 6 weeks after the intervention_ 12 weeks after the intervention. Method of measurement: CAL: The distance from Cej to the apical depth of the probe is in millimeters. GBI: whether probing causes bleeding (+) or not (-) is assessed. PPD: the distance from the free margin of the gingiva to the bottom of the sulcus depth in millimeters. GI: ​​evaluation of the intensity and amount of gingival inflammation with BOP of the tooth. PI: It is based on the registration of soft debris and mineral deposits on the following teeth: upper right first molar, upper right lateral, upper left first premolar, lower left first molar, lower left lateral and lower right first premolar.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-29</approval_date>
        <contact_name>Golestan University of Medical Sciences</contact_name>
        <contact_address>Gorgan - Hirkan Boulevard - Central Organization of Golestan University of Medical Sciences and Healthcare Services gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
