Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223195
• Other study ID #: MC 2
• Status: Completed
• Start date: March 2015
• Est. completion date: October 2019

Study information

• Verified date: August 2020
• Source: Folktandvården Stockholms län AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Locations

Country	Name	City	State
Sweden	Folktandvården Stockholmslän AB	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Folktandvården Stockholms län AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.	Saliva sampels will be colleceted and analysed	one day