Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT02223195
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2014-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis
Sponsor:
Folktandvården Stockholms län AB
Organization:
Study Overview
Official Title:
Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: