<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02223195</url>
  </required_header>
  <id_info>
    <org_study_id>MC 2</org_study_id>
    <nct_id>NCT02223195</nct_id>
  </id_info>
  <brief_title>Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis</brief_title>
  <official_title>Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Folktandvården Stockholms län AB</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Folktandvården Stockholms län AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose and aims This as a pilot study that aims to investigate which inflammatory biomarkers&#xD;
      can be found in saliva in children with Juvenile Idiopathic Arthritis (JIA).&#xD;
&#xD;
      The hypothesis is that children with JIA will show a different pattern of inflammatory&#xD;
      biomarkers in saliva than healthy Children.&#xD;
&#xD;
      The null hypothesis is that there are no differences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a comparison between 100 children with JIA and 100 healthy children. Saliva will be&#xD;
      collected and analyzed with respect to biomarkers.&#xD;
&#xD;
      One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric&#xD;
      Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.&#xD;
&#xD;
      Inclusion criteria are:&#xD;
&#xD;
        -  age between 7 and 14 years&#xD;
&#xD;
        -  a diagnosis of JIA according to the International League of Associations for&#xD;
           rheumatology&#xD;
&#xD;
      Exclusion criteria are:&#xD;
&#xD;
        -  current malignancies&#xD;
&#xD;
        -  TMJ surgery or trauma within two years&#xD;
&#xD;
        -  recent intra-articular glucocorticoid injection in TMJ (within 1 month)&#xD;
&#xD;
        -  other conditions or diseases than JIA that may cause orofacial pain. The parents of the&#xD;
           patients and/or the patients will give their verbal and written informed consent to&#xD;
           participate in the study according to the permission from the regional ethical committee&#xD;
           2011/2:1.&#xD;
&#xD;
      The control group of 100 age and sex matched healthy children will be included at&#xD;
      Folktandvården Stockholms Län AB.&#xD;
&#xD;
      Inclusion criteria are:&#xD;
&#xD;
      • age between 7 and 14 years&#xD;
&#xD;
      Exclusion criteria are:&#xD;
&#xD;
        -  current malignancies&#xD;
&#xD;
        -  TMJ surgery or trauma within two years&#xD;
&#xD;
        -  recent intra-articular glucocorticoid injection in TMJ (within 1 month)&#xD;
&#xD;
        -  A diagnosis of JIA&#xD;
&#xD;
        -  other conditions or diseases than JIA that may cause orofacial pain. The parents of the&#xD;
           patients and/or the patients will give their verbal and written informed consent to&#xD;
           participate in the study according to the permission from the regional ethical committee&#xD;
           2011/2:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.</measure>
    <time_frame>one day</time_frame>
    <description>Saliva sampels will be colleceted and analysed</description>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva sampels&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: 40 consecutive patients with active JIA, as diagnosed by the Department of&#xD;
        Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will&#xD;
        be included.&#xD;
&#xD;
        Group 2: 40 healthy children, age-and sex-matched.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. A diagnosis of JIA according to the International League of Associations for&#xD;
        rheumatology (ILAR) The parents of the patients and/or the patients will give their verbal&#xD;
        and written informed consent to participate in the study according to the permission from&#xD;
        the regional ethical committee 2011/2:1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. current malignancies&#xD;
&#xD;
          2. TMJ surgery or trauma within two years&#xD;
&#xD;
          3. Recent intra-articular glucocorticoid injection in TMJ (within 1 month)&#xD;
&#xD;
          4. Other conditions or diseases than JIA that may cause orofacial pain. Fore the&#xD;
             controllgroup JIA are excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Britt Hedenberg Magnusson, PhD DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Folktandvården Stockholmslän AB</name>
      <address>
        <city>Stockholm</city>
        <zip>17267</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Folktandvården Stockholms län AB</investigator_affiliation>
    <investigator_full_name>Malin Collin</investigator_full_name>
    <investigator_title>PhD student, DDS</investigator_title>
  </responsible_party>
  <keyword>Juvenile Idiopathic Arthritis</keyword>
  <keyword>Saliva</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 3, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223195
org study id: MC 2
nct id: NCT02223195
lead sponsor: 
has dmc: No
Purpose and aims This as a pilot study that aims to investigate which inflammatory biomarkers
      can be found in saliva in children with Juvenile Idiopathic Arthritis (JIA).

      The hypothesis is that children with JIA will show a different pattern of inflammatory
      biomarkers in saliva than healthy Children.

      The null hypothesis is that there are no differences.
This is a comparison between 100 children with JIA and 100 healthy children. Saliva will be
      collected and analyzed with respect to biomarkers.

      One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric
      Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.

      Inclusion criteria are:

        -  age between 7 and 14 years

        -  a diagnosis of JIA according to the International League of Associations for
           rheumatology

      Exclusion criteria are:

        -  current malignancies

        -  TMJ surgery or trauma within two years

        -  recent intra-articular glucocorticoid injection in TMJ (within 1 month)

        -  other conditions or diseases than JIA that may cause orofacial pain. The parents of the
           patients and/or the patients will give their verbal and written informed consent to
           participate in the study according to the permission from the regional ethical committee
           2011/2:1.

      The control group of 100 age and sex matched healthy children will be included at
      Folktandvården Stockholms Län AB.

      Inclusion criteria are:

      • age between 7 and 14 years

      Exclusion criteria are:

        -  current malignancies

        -  TMJ surgery or trauma within two years

        -  recent intra-articular glucocorticoid injection in TMJ (within 1 month)

        -  A diagnosis of JIA

        -  other conditions or diseases than JIA that may cause orofacial pain. The parents of the
           patients and/or the patients will give their verbal and written informed consent to
           participate in the study according to the permission from the regional ethical committee
           2011/2:1.
observational model: Cohort
time perspective: Prospective
measure: Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.
time frame: one day
description: Saliva sampels will be colleceted and analysed
Saliva sampels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: No
last name: Britt Hedenberg Magnusson, PhD DDS
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Folktandvården Stockholms län AB
investigator full name: Malin Collin
investigator title: PhD student, DDS
mesh term: Arthritis
mesh term: Arthritis, Juvenile
submitted: March 3, 2023