Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis

Completed

• Conditions: Juvenile Idiopathic Arthritis

• Registration Number: NCT02223195
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Study Start: 2015-03
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.	one day	Saliva sampels will be colleceted and analysed

Trial Locations

Locations (1)

Folktandvården Stockholmslän AB; 🇸🇪 Stockholm, Sweden