<?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>IRCT20190422043346N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-27</date_registration>
      <primary_sponsor>Vice-Chancellor's Office for Research of birjand university of medical science</primary_sponsor>
      <public_title>effect of SRP on hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing of the effect of scaling and rootplaning on the periodontal condition of hemodialysis and normal patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39265</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: After enrolling patients and placing them in their own groups, they receive scaling and root planning by a clinician.
All calculations on the day of treatment (before treatment), week 4 and 8 after treatment will be done by another clinician, this clinician has no information about the totality of the treatment that received by the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patient undergoing hemodialysis.</hc_freetext>
      <i_freetext>Intervention and case group: scaling and root planing and mouth health education.Before starting the treatment, the patients were given the same health education and they were asked to use dental floss to clean the interdental surfaces and then use the tooth brush (Soft 35) and toothpaste twice a day.One week later, all Dental calculations (6 areas in each tooth including Mesiobaccal Midbacal Distobaccal mesiolingual Mid Lingual and Distolingual) were performed. Clinical calculations were performed to determine the depth of the pocket probing (PPD) and determine the clinical attachment loss (CAL) in millimeters in 6 areas of Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44).Then the samples received scaling treatment. scaling(SRP) is the removal of clalculus and fragments of contaminated cementios from the root to provide a smooth, hard, and free surface..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The whole potential data is publishable after being unidentifiable

When:
Starting the access period from 2020

To whom:
Researchers working in academia and those involved in the industry can recieve for data.

Conditions:
Any use and analysis of the data in this study is allowed

Where to obtain:
alingv94@gmail.com 
+989024926756
ali naghavi

How to obtain:
After requesting the data, the email will be sent to the applicant in less than three days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Naghavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 38, farvardin 10, farhangian town</address>
        <city>fariman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 51 3462 3647</telephone>
        <email>alingv94@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Naghavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 38, Farvardin 10, Farhangian town</address>
        <city>Fariman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 51 3462 3647</telephone>
        <email>alingv94@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
INR less than 4
Having at least one premolar molar and two anterior teeth in each quadrant of mouth
Having at least one area with a depth of 3 mm and more in at least 2 quadrants from the mouth
The presence of a zone with a lashing attachment greater than 2 mm
plaque Index(PI) below 30%
They are currently being treated for dialysis and having a minimum of three months of dialysis (for the case group)
Availability of Persons and Written Satisfaction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Get periodontal treatment (SRP) in the last 6 months
The presence of a systemic disease that affects the periodontal condition
smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for fitting and adjustment of extracorporeal dialysis catheter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention and case group: scaling and root planing and mouth health education.Before starting the treatment, the patients were given the same health education and they were asked to use dental floss to clean the interdental surfaces and then use the tooth brush (Soft 35) and toothpaste twice a day.One week later, all Dental calculations (6 areas in each tooth including Mesiobaccal Midbacal Distobaccal mesiolingual Mid Lingual and Distolingual) were performed. Clinical calculations were performed to determine the depth of the pocket probing (PPD) and determine the clinical attachment loss (CAL) in millimeters in 6 areas of Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44).Then the samples received scaling treatment. scaling(SRP) is the removal of clalculus and fragments of contaminated cementios from the root to provide a smooth, hard, and free surface.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Periodontal pocket depth. Timepoint: At the beginning of the study, four weeks and eight weeks after the intervention. Method of measurement: periodontal prob of WHO in mili meter.</prim_outcome>
      <prim_outcome>Clinical attachment loss. Timepoint: At the beginning of the study, four weeks and eight weeks after the intervention. Method of measurement: periodontal prob of WHO in mili meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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's Office for Research of birjand university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-30</approval_date>
        <contact_name>Ethics committee of birjand University of Medical Sciences</contact_name>
        <contact_address>Ghaffari Blvd , Birjand university of medical science birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
