The Role of Cytokines as Inflammatory Mediators in Painful Temporomandibular Joints
The proposed clinical trial will consist of two parallel studies. In the first part of the
study, we will evaluate the analgesia and adverse effects of celecoxib, a COX-2 inhibitor in
comparison to naproxen and placebo of patients with temporomandibular disorders (TMD).
Celecoxib, is in oral anti-inflammatory and analgesic agent that acts by selectively
inhibiting cyclooxygenase 2 (COX-2) and is not expected to cause the typical
gastrointestinal, and platelet-related side effects associated with inhibition of the COX-1
enzyme. Decrease in pain, dysfunction and improvement in quality of life will be assessed
at base line and after 6-week follow-up. Successful demonstration of an enhanced
therapeutic effect or reduced toxicity may provide a basis for clinical use of selective
COX-2 inhibitors in patients with painful TMD.
In a second group of carefully selected patients, we will evaluate the short-term effect
etanercept (Enbrel) in comparison to placebo in patients who had pain and tenderness to
palpation in the temporomandibular joint (TMJ osteoarthritis) of at least three month
duration and who had not responded to conservative treatment. Etanercept is a biologic
modifier that binds specifically to tumor necrosis factor alpha (TNF alpha). The mechanism
of action of etanercept is competitive inhibition of TNF binding to cell-surface TNF
receptors (TNFR), preventing TNF-mediated cellular responses by rendering TNF biologically
inactive. Subjects will be randomly assigned to either etanercept or placebo
administration. At baseline and at 6-week follow up individual outcomes will be assessed
such as pain, mandibular range of motion along with the analysis of the sample synovial
fluid level of TNF alpha. By studying the joint fluid levels of TNF alpha, we will learn
more about the development of the local inflammatory process in the joint, which will help
in predicting the prognosis for patients with these TM joint disorders. Positive findings
will also provide clinical implications of etanercept in patients with painful TMJ
osteoarthritis.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
000037
NCT00001955
December 1999
February 2004
Name | Location |
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National Institute of Dental And Craniofacial Research (NIDCR) | Bethesda, Maryland 20892 |