<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/NCT02218892</url>
  </required_header>
  <id_info>
    <org_study_id>2010/2089-31/2</org_study_id>
    <nct_id>NCT02218892</nct_id>
  </id_info>
  <brief_title>Prediction of Temporomandibular Involvement in Juvenile Idiopathic Arthritis</brief_title>
  <official_title>Prediction of Temporomandibular Involvement in Juvenile Idiopathic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malin Collin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Folktandvården Stockholms län AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose and aims The general aim of this project is to improve the diagnostic methods for&#xD;
      disease activity and identify predictive factors (clinical and radiographic factors, pro- and&#xD;
      anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ)&#xD;
      involvement in juvenile idiopathic arthritis (JIA).&#xD;
&#xD;
      The hypothesis is that self-reported pain and impaired jaw function together with clinical&#xD;
      findings correlates well with radiological signs of jaw involvement.&#xD;
&#xD;
      Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not&#xD;
      correlate with radiological signs of jaw involvement.&#xD;
&#xD;
      Study 1 The aim of this study is to investigate which findings from the patient history and&#xD;
      from clinical examination that is of significance for diagnostics of TMJ involvement in&#xD;
      patients with JIA both in a short- and long-term perspective. The patients will be&#xD;
      followed-up during two years. They will undergo a clinical examination according to Research&#xD;
      Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once&#xD;
      a year and a telephone follow-up sixth months after the clinical examination. Further, the&#xD;
      clinical findings from the orofacial regions will be compared to their general disease&#xD;
      activity.&#xD;
&#xD;
      Study 2 The aim of the second study is to correlate radiological findings and clinical&#xD;
      findings in order to investigate any early radiological signs of disease activity and&#xD;
      progression but also to compare the radiographic examination using conventional panoramic&#xD;
      technique with computer tomography (CT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      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;
      Clinical examination and follow-ups The patients will be examined clinically three times with&#xD;
      an interval of 12 months. The clinical examination will be performed according to the RDC-TMD&#xD;
      by calibrated investigators. Panoramic x-ray and CT scans will be performed at the inclusion&#xD;
      examination as well as at the end of the study after 24 months. Pharmacological treatment&#xD;
      will be recorded at every clinical examination and at telephone interviews. The patients will&#xD;
      also be examined by a pediatric rheumatologist regarding general disease activity according&#xD;
      to the Juvenile Arthritis Disease Activity Score 27 (JADAS-27), the Short Form (36) Health&#xD;
      Survey (SF-36), thrombocyte particle count, C-reactive protein and blood titer of rheumatoid&#xD;
      factor and anti-cyclic citrullinated peptides. Information from the examination by the&#xD;
      pediatric rheumatologist will be drawn from the Swedish national register for children with&#xD;
      JIA.&#xD;
&#xD;
      Telephone interview Six months after the first and second visit, a structured telephone&#xD;
      interview with the patients and/or their parents will be performed according to a&#xD;
      questionnaire. The objective is to estimate the degree of joint pain and functional&#xD;
      limitations in jaw function.&#xD;
&#xD;
      Radiological examination Conventional panoramic x-rays and bilateral TMJ images will be&#xD;
      obtained with the digital volume tomography (DVT, New Tom Model QR-DVT 9000, New Tom AG,&#xD;
      Marburg, Germany). The CT sections will be evaluated by a specialist in oral radiology for&#xD;
      presence of radiographic signs of cortical and subcortical erosions, flattening, sclerosis&#xD;
      and ramus height.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Clinical findings in children with JIA</measure>
    <time_frame>2 years</time_frame>
    <description>To find similarities in patients with JIA according to RDC-TMD (a clinical protocol validated for children)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic findings in children with JIA</measure>
    <time_frame>Two years</time_frame>
    <description>Repeated radiographic examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient history</measure>
    <time_frame>Two years</time_frame>
    <description>Repeated interview on function and pain in the jaw area</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <condition>Temporomandibular Arthritis</condition>
  <arm_group>
    <arm_group_label>Juvenil Idiopathic Arthritis</arm_group_label>
    <description>The group consists of children age 7-14 with an diagnosis of active Juvenile Idiopathic Arthritis.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, serum,saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        One-hundred 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;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 7 and 14 years&#xD;
&#xD;
          2. 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&#xD;
             verbal and written informed consent to participate in the study according to the&#xD;
             permission from 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.&#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>Study Director</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Folktandvården Stockholmslän AB</name>
      <address>
        <city>Stockholm</city>
        <zip>14463</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Folktandvården Stockholms län AB</investigator_affiliation>
    <investigator_full_name>Malin Collin</investigator_full_name>
    <investigator_title>DDS, PhD-student</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT02218892
org study id: 2010/2089-31/2
nct id: NCT02218892
lead sponsor: 
collaborator: 
has dmc: No
Purpose and aims The general aim of this project is to improve the diagnostic methods for
      disease activity and identify predictive factors (clinical and radiographic factors, pro- and
      anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ)
      involvement in juvenile idiopathic arthritis (JIA).

      The hypothesis is that self-reported pain and impaired jaw function together with clinical
      findings correlates well with radiological signs of jaw involvement.

      Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not
      correlate with radiological signs of jaw involvement.

      Study 1 The aim of this study is to investigate which findings from the patient history and
      from clinical examination that is of significance for diagnostics of TMJ involvement in
      patients with JIA both in a short- and long-term perspective. The patients will be
      followed-up during two years. They will undergo a clinical examination according to Research
      Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once
      a year and a telephone follow-up sixth months after the clinical examination. Further, the
      clinical findings from the orofacial regions will be compared to their general disease
      activity.

      Study 2 The aim of the second study is to correlate radiological findings and clinical
      findings in order to investigate any early radiological signs of disease activity and
      progression but also to compare the radiographic examination using conventional panoramic
      technique with computer tomography (CT).
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.

      Clinical examination and follow-ups The patients will be examined clinically three times with
      an interval of 12 months. The clinical examination will be performed according to the RDC-TMD
      by calibrated investigators. Panoramic x-ray and CT scans will be performed at the inclusion
      examination as well as at the end of the study after 24 months. Pharmacological treatment
      will be recorded at every clinical examination and at telephone interviews. The patients will
      also be examined by a pediatric rheumatologist regarding general disease activity according
      to the Juvenile Arthritis Disease Activity Score 27 (JADAS-27), the Short Form (36) Health
      Survey (SF-36), thrombocyte particle count, C-reactive protein and blood titer of rheumatoid
      factor and anti-cyclic citrullinated peptides. Information from the examination by the
      pediatric rheumatologist will be drawn from the Swedish national register for children with
      JIA.

      Telephone interview Six months after the first and second visit, a structured telephone
      interview with the patients and/or their parents will be performed according to a
      questionnaire. The objective is to estimate the degree of joint pain and functional
      limitations in jaw function.

      Radiological examination Conventional panoramic x-rays and bilateral TMJ images will be
      obtained with the digital volume tomography (DVT, New Tom Model QR-DVT 9000, New Tom AG,
      Marburg, Germany). The CT sections will be evaluated by a specialist in oral radiology for
      presence of radiographic signs of cortical and subcortical erosions, flattening, sclerosis
      and ramus height.
observational model: Cohort
time perspective: Prospective
measure: Clinical findings in children with JIA
time frame: 2 years
description: To find similarities in patients with JIA according to RDC-TMD (a clinical protocol validated for children)
measure: Radiographic findings in children with JIA
time frame: Two years
description: Repeated radiographic examination
measure: Patient history
time frame: Two years
description: Repeated interview on function and pain in the jaw area
arm group label: Juvenil Idiopathic Arthritis
description: The group consists of children age 7-14 with an diagnosis of active Juvenile Idiopathic Arthritis.
whole blood, serum,saliva
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: Study Director
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Folktandvården Stockholms län AB
investigator full name: Malin Collin
investigator title: DDS, PhD-student
mesh term: Arthritis
mesh term: Arthritis, Juvenile