Status:
WITHDRAWN
The Use of PET/CT to Evaluate Synovitis in the Temporomandibular Joint (TMJ)
Lead Sponsor:
University of Pennsylvania
Conditions:
Temporomandibular Joint
Conservative Treatment Therapy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent of the patients who se...
Detailed Description
This is a prospective, double-blinded, pilot study to evaluate the ability of PET/CT with FDG to detect synovitis of the temporomandibular joint. Patients presenting to the Department of Oral and Maxi...
Eligibility Criteria
Inclusion
- Key inclusion criteria include any individual found to have a primary diagnosis of internal derangement of the temporomandibular joint requiring arthroscopy as determined by the treating physician.
- All patients will have failed a trial period of "conservative treatment therapy" including occlusal splint therapy, NSAIDs, or muscle relaxants for a period no less than eight weeks, as per standard of care.
- All patients will be between the ages of 18 and 70.
Exclusion
- Exclusion criteria will include patients not medically stable to undergo arthroscopy under general anesthesia, patients with overlying infection of the skin, uncontrolled diabetes, patients with bilateral TMJ internal derangement, pregnancy, and patients with conditions other than internal derangement causing temporomandibular pain or dysfunction.
- Patients less than 18 or greater than 70 years of age will also be excluded.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01471418
Start Date
December 1 2011
End Date
October 1 2012
Last Update
July 8 2015
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104