Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis

NCT ID: NCT02223195

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-10-31

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.

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Folktandvården Stockholms län AB

OTHER_GOV

Sponsor Role: lead

Responsible Party

Malin Collin

PhD student, DDS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Britt Hedenberg Magnusson, PhD DDS

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Folktandvården Stockholmslän AB

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

MC 2

Identifier Type: -

Identifier Source: org_study_id