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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02223195
Study type Observational
Source Folktandvården Stockholms län AB
Contact
Status Completed
Phase
Start date March 2015
Completion date October 2019

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