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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00801593
Other study ID # TMJ PROSPECT2008
Secondary ID
Status Recruiting
Phase N/A
First received December 2, 2008
Last updated December 2, 2008
Start date May 2008
Est. completion date June 2010

Study information

Verified date December 2008
Source University Hospital Tuebingen
Contact Nikolay Tzaribachev, MD
Phone +49707129
Email nikolay.tzaribachev@med.uni-tuebingen.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria:

- Children with defined JIA.

Exclusion Criteria:

- Children without defined diagnosis of JIA.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Steroid injection into the TMJs.
In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance.

Locations

Country Name City State
Germany University Children's Hospital Tuebingen Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary TMJ arthritis on MRI every three to six months from recruitment to end of study No
Secondary TMJ arthritis on ultrasound every three to six months from recruitment to end of study No
Secondary Action of current medication on TMJ arthritis. every three to six months from recruitment to end of study No
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