Temporomandibular Joint Clinical Trial
Official title:
Investigation of the Use of Positron Emission Tomography With 18F-FDG PET/CT for the Diagnosis of Synovitis in the Temporomandibular Joint
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 seek care for one of these conditions, will go on to develop chronic
pain. The two most common TMD conditions include myofascial pain disorder and internal
derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical
presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam
or test to differentiate between these two conditions.
Internal derangement of the TMJ is a condition with disk displacement, pain, and
dysfunction, which may progress to localized osteoarthritis. Fortunately, this condition is
self-limiting for the majority of the patients afflicted, with a small minority progressing
to advanced joint destruction, disability and chronic pain.18 Currently there are no
prognostic indicators to identify these individuals. There are three hypothesis of
degenerative TMJ disease, they include: direct mechanical trauma, hypoxia reperfusion
injuries, and neurogenic inflammation. All involve parafunctional habits such as clenching
or grinding by the patient and a low-grade inflammatory response/synovitis.
18-fluorodeoxyglucose (18-FDG), a radioisotope used with positron emission tomography (PET)
and paired with a CT scan (PET/CT), may have a role in imaging inflammation in arthritis as
recently demonstrated in several pilot studies involving osteoarthritis of the knee and
shoulder. 18-FDG accumulates in areas of increased metabolism, particularly activated
leukocytes, as measured by increased standardized uptake value.2 PET/CT offers the unique
advantage of showing active disease before anatomic damage is evident. Our hypothesis is
that there is an increased uptake of 18-FDG on PET/CT in synovitis of the TMJ.
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 Maxillofacial Surgery at the Hospital of the University of
Pennsylvania with symptomatic internal derangement of the temporomandibular joint requiring
arthroscopy will be compared to control subjects. 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.
Exclusion criteria will include patients not medically stable to undergo arthroscopy under
general anesthesia, patients with overlying infection of the skin, patients with conditions
other than internal derangement causing temporomandibular pain or dysfunction.
Once a patient has been identified as eligible for the study, the treating physician will
contact a member of the study team. Each participating patient will undergo a standardized
exam, the research diagnostic criteria for TMD (RDC/TMD). A member of the research team,
from the department of oral medicine, will administer this exam. This standardized exam has
been previously validated in the literature, and each member of the research team will
undergo training and calibration prior to administering the RDC/TMD. This exam will be
performed on the day of the arthroscopy. In addition, each patient will be given a Wilkes
score, based on the Wilkes classification of internal derangement.36 The patient will then
undergo arthroscopy of the temporomandibular joint as per the treating physician. TMJ
arthroscopy includes: a small incision in front of the ear, introduction of an arthroscope
and irrigation needle into the joint space, irrigation of fluid, and at the discretion of
the treating physician may include the lysis of adhesion and the introduction of medication
into the joint. At the time of the procedure, the synovitis score will be determined based
on an eleven point synovitis scale as described by Murakami, with zero being absence of
synovial inflammation. This scoring is bone by observation, and is typically include in the
arthroscopy procedure for diagnosis. The patient will also be given a binomial score of
presence or absence of synovitis. A representative photograph will be obtained of the
patient's joint during arthroscopy, as is routinely done during this procedures.
Prior to the procedure, the patients will have undergone a PET/CT scan to evaluate the TMJ.
This radiographic exam will be limited to the head and neck region in order to minimize
radiation exposure. The radiologists reading the study will be blinded to the results of the
clinical exam and condition. The results of the PET/CT study will be given as a binomial
score of positive or negative and given a continuous score based on uptake relative to the
unaffected joint.
Control subjects will undergo the RDC/TMD standardized exam prior to the radiographic study,
and only have the PET/CT performed, with no subsequent intervention. These patients will be
aged matched to the treatment subjects. This information will then be utilized to determine
the utility of PET/CT in the detection of synovitis of the temporomandibular joint.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Diagnostic
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