<?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>IRCT2015122512823N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-04</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the treatment of periodontitis on rheumatoid arthritis disease activity</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the treatment of periodontitis on rheumatoid arthritis disease activity in patients who referred to Rheumatology clinic, Semnan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Periodontitis. Condition 2: Rheumatoid arthritis.</hc_freetext>
      <i_freetext>Interventions: At first, DAS-28 questionnaire filled and if periodontitis confirmed by dentist, treatment initiated which is includes non surgical scaling, root planning, systemic antibiotics (metronidazole 500 mg three time per day and amoxicillin 500 mg three time per day for a ten days period), antiseptic (Chlorhexidine gluconate oral rinse 0.12% 2 time per day) and oral health education. At the end of treatment period, on 20th day of study all patients will be visited by dentist and if he confirm complete remission, on days 45 and 90 after initiation all patients will be visited by rheumatologist and DAS-28 questionnaire completed again. ESR and CRP are also measured at each visit in a reference laboratory.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Background: Many patients with rheumatoid arthritis (RA), which is one of the most common inflammatory diseases, at the same time, suffer from periodontitis. Since some studies have shown a common biochemical link between the synchronicity of these two diseases, we decided to investigate the effects of periodontal therapy on disease activity in RA.&lt;br /&gt;&#13;
Materials and Methods: In this quasi-experimental study, 30 patients with simultaneous RA and periodontitis referred to the rheumatology clinic in Semnan from March 2014 to February 2016 were selected through census method. Disease activity score uses 28 joint counts (DAS28) questionnaires were completed and referred to executive dentist of the project. Patients with confirmed periodontitis were received treatments including non-surgical scaling, Root planning, systemic antibiotics (10-day period, capsules of amoxicillin and metronidazole, 3 per day) and chlorhexidine as well as oral health education. Then, at days 45 and 90 after treatment, the patients were visited by a rheumatologist and DAS28 questionnaire was again completed. ESR and CRP of each visit were evaluated in reference laboratories at Semnan University of Medical Sciences.&lt;br /&gt;&#13;
Results: the evaluation of 30 patients with mean age of 50.2±10.62 years (80% female) showed that the difference in the level of disease activity between baseline versus 45 days later (5.18±0.092 vs 4.02±1.22, p</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. Jamileh Moghimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar Hospital, Basidj Boulevard, Amin Avenue</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 3343 7821</telephone>
        <email>moghimi_jam@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Jamileh Moghimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar hospital, Amin Avenue, Basidj Boulevard</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 3343 7821</telephone>
        <email>moghimi_jam@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 18 years and older; diagnosis of RA at least one year ago; disease activity score between 3.2 and 5.1; having at least six natural teeth; the patient be educable; having gingivitis with mild to moderate degree.&#13;
The exclusion criteria were: risk of infection; serious liver or kidney diseases; chronic infectious disease that needs to frequent use of antibiotics; uncontrolled diabetes; taking anti-thrombotic and biologic therapy; sensitivity to chlorhexidine gluconate (oral rinse); contraindication of amoxicillin and metronidazole; severe oral problems which requiring immediate surgery; pregnancy, breast-feeding or if want to get pregnant during the study period; any febrile or chronic diseases.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.3</hc_code>
      <hc_code>M06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic periodontitis</hc_keyword>
      <hc_keyword>Rheumatoid arthritis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions: At first, DAS-28 questionnaire filled and if periodontitis confirmed by dentist, treatment initiated which is includes non surgical scaling, root planning, systemic antibiotics (metronidazole 500 mg three time per day and amoxicillin 500 mg three time per day for a ten days period), antiseptic (Chlorhexidine gluconate oral rinse 0.12% 2 time per day) and oral health education. At the end of treatment period, on 20th day of study all patients will be visited by dentist and if he confirm complete remission, on days 45 and 90 after initiation all patients will be visited by rheumatologist and DAS-28 questionnaire completed again. ESR and CRP are also measured at each visit in a reference laboratory</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rheumatoid arthritis activity. Timepoint: Before initiation of interventions, 45 and 90 days after intervention. Method of measurement: DAS-28 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Erythrocyte Sedimentation Rate. Timepoint: Before initiation of interventions, 45 and 90 days after intervention. Method of measurement: Laboratory test.</sec_outcome>
      <sec_outcome>C- reactive protein. Timepoint: Before initiation of interventions, 45 and 90 days after intervention. Method of measurement: Laboratory test.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-01</approval_date>
        <contact_name>Ethical Commettee of Semnan University of Medical Sicenses</contact_name>
        <contact_address>Basidj Boulevard Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
