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Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis
This study is currently recruiting participants.
Verified by University Hospital Tuebingen, December 2008
Sponsored by: University Hospital Tuebingen
Information provided by: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00801593
  Purpose

Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement.

Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography results and to describe the action of the current medication on the arthritis of the TMJs.


Condition Intervention
Juvenile Idiopathic Arthritis
Procedure: Steroid injection into the TMJs.

MedlinePlus related topics: Juvenile Rheumatoid Arthritis MRI Scans Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Arthritis of the Temporomandibular Joints in Children With Juvenile Idiopathic Arthritis- Pilot Study on Diagnostic Value of Ultrasonography and Magnetic Resonance Imaging and Influence of Drug Treatment

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • TMJ arthritis on MRI [ Time Frame: every three to six months from recruitment to end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TMJ arthritis on ultrasound [ Time Frame: every three to six months from recruitment to end of study ] [ Designated as safety issue: No ]
  • Action of current medication on TMJ arthritis. [ Time Frame: every three to six months from recruitment to end of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children with JIA Procedure: Steroid injection into the TMJs.
In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children with JIA.

Criteria

Inclusion Criteria:

  • Children with defined JIA.

Exclusion Criteria:

  • Children without defined diagnosis of JIA.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801593

Contacts
Contact: Nikolay Tzaribachev, MD +49707129 ext 84711 nikolay.tzaribachev@med.uni-tuebingen.de

Locations
Germany, Baden-Wuerttemberg
University Children's Hospital Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Contact: Nikolay Tzaribachev, MD     +49707129 ext 84711     nikolay.tzaribachev@med.uni-tuebingen.de    
Principal Investigator: Nikolay Tzaribachev, MD            
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Nikolay Tzaribachev, MD University Hospital Tuebingen
  More Information

Responsible Party: University Children's Hospital, Tuebingen ( Nikolay Tzaribachev, Dr. )
Study ID Numbers: TMJ PROSPECT2008
Study First Received: December 2, 2008
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00801593  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
JIA

Study placed in the following topic categories:
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009