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Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00801593
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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
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

No publications provided

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

Keywords provided by University Hospital Tuebingen:
JIA

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013