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OpenTrials
Completed

NCT Number: NCT02223195

Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Folktandvården Stockholmslän AB

Stockholm, 17267, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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. Fore the controllgroup JIA are excluded

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Folktandvården Stockholms län AB

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2014
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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