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Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis

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ClinicalTrials.gov Identifier: NCT02223195
Recruitment Status : Recruiting
First Posted : August 22, 2014
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Malin Collin, Folktandvården Stockholms län AB

Brief Summary:

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.


Condition or disease
Juvenile Idiopathic Arthritis

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis. [ Time Frame: one day ]
    Saliva sampels will be colleceted and analysed


Biospecimen Retention:   Samples With DNA
Saliva sampels


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group 1: 40 consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.

Group 2: 40 healthy children, age-and sex-matched.

Criteria

Inclusion Criteria:

1. A diagnosis of JIA according to the International League of Associations for rheumatology (ILAR) 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

Exclusion Criteria:

  1. current malignancies
  2. TMJ surgery or trauma within two years
  3. Recent intra-articular glucocorticoid injection in TMJ (within 1 month)
  4. Other conditions or diseases than JIA that may cause orofacial pain. Fore the controllgroup JIA are excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223195


Contacts
Contact: Malin Collin, DDS 0046812316583 malin.collin@ki.se
Contact: Britt Hedenberg, PhD DDS 0046812315683 britt.hedenberg@ftv.sll.se

Locations
Sweden
Folktandvården Stockholmslän AB Recruiting
Stockholm, Sweden, 17267
Contact: Malin Collin    0046812315683    malin.collin@ki.se   
Contact: Britt Hedenberg Magnusson, PhD DDS    0046812316583    britt.hedenberg@ftv.sll.se   
Sponsors and Collaborators
Folktandvården Stockholms län AB
Investigators
Principal Investigator: Britt Hedenberg Magnusson, PhD DDS Karolinska Institutet

Responsible Party: Malin Collin, PhD student, DDS, Folktandvården Stockholms län AB
ClinicalTrials.gov Identifier: NCT02223195     History of Changes
Other Study ID Numbers: MC 2
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by Malin Collin, Folktandvården Stockholms län AB:
Juvenile Idiopathic Arthritis
Saliva

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases