Prediction of Temporomandibular Involvement in Juvenile Idiopathic Arthritis

NCT02218892 | Unknown

• 1 other identifier: 2010/2089-31/2
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose and aims The general aim of this project is to improve the diagnostic methods for disease activity and identify predictive factors (clinical and radiographic factors, pro- and anti-inflammatory mediators in saliva and plasma) for temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA). The hypothesis is that self-reported pain and impaired jaw function together with clinical findings correlates well with radiological signs of jaw involvement. Null hypothesis: Self-reported pain, impaired jaw function and clinical findings do not correlate with radiological signs of jaw involvement. Study 1 The aim of this study is to investigate which findings from the patient history and from clinical examination that is of significance for diagnostics of TMJ involvement in patients with JIA both in a short- and long-term perspective. The patients will be followed-up during two years. They will undergo a clinical examination according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD; Dworkin and LeResche 1992) once a year and a telephone follow-up sixth months after the clinical examination. Further, the clinical findings from the orofacial regions will be compared to their general disease activity. Study 2 The aim of the second study is to correlate radiological findings and clinical findings in order to investigate any early radiological signs of disease activity and progression but also to compare the radiographic examination using conventional panoramic technique with computer tomography (CT).

Conditions

Juvenile Idiopathic Arthritis; Temporomandibular Arthritis

Outcome Measures

Primary Outcomes (3)

• Clinical findings in children with JIA

  To find similarities in patients with JIA according to RDC-TMD (a clinical protocol validated for children)

  2 years

• Radiographic findings in children with JIA

  Repeated radiographic examination

  Two years

• Patient history

  Repeated interview on function and pain in the jaw area

  Two years

Study Arms (1)

Juvenil Idiopathic Arthritis

The group consists of children age 7-14 with an diagnosis of active Juvenile Idiopathic Arthritis.

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.

You may qualify if:

• age between 7 and 14 years
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Malin Collin: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Folktandvården Stockholmslän AB

Stockholm, 14463, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum,saliva

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Britt Hedenberg Magnusson, PhD DDS

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, PhD-student

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: August 18, 2014
• Study Start: February 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

SE (1)