Synvisc to Treat Osteoarthritis of the Temporomandibular Joint
This study will examine the effectiveness of injected hylan (Synvisc) for treating pain associated with osteoarthritis of the temporomandibular joint (jaw joint) and improving function of the joint. Hylan is a synthetic product very similar to a component of normal healthy joint fluid (synovial fluid), which is present in much lower quantities and is abnormal in osteoarthritis. Hylan injections have been beneficial in treating osteoarthritis of the knee.
Patients with temporomandibular (TMJ) joint pain of at least 3 months duration who have mouth opening limitation and moderate to severe joint pain made worse by joint movement may be eligible for this study. Patients must not have any TMJ growth disturbances and must not have had any TMJ surgery for 6 months before entering the study. Candidates are screened with questionnaires, a medical history, and a physical examination of the TMJs, including x-rays and magnetic resonance imaging.
Participants are randomly assigned to receive three injections, each a week apart, of either Synvisc or placebo (a salt-water solution) into the affected joint. Before the first injection, a sample of synovial fluid is collected from the joint by needle aspiration for laboratory analysis. Patients return for follow-up visits 3, 6, and 12 months after the last treatment for a clinical examination of the jaw joint and review of jaw joint symptoms. A second aspiration is requested at the 3-month visit, but is not mandatory. All injections and aspirations are done after anesthetizing the overlying skin and joint capsule to minimize pain or discomfort. Participants record their daily use of pain relief medication throughout the study.
Procedure: High molecular weight hylan (Synvisc) injection
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Official Title:||The Effects of Viscosupplementation Using Synvisc in Symptomatic Osteoarthritis of the Temporomandibular Joint|
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||October 2005|
The proposed clinical trial will evaluate the effects of high molecular weight hylan (Synvisc) injection in comparison with control treatment (saline injection) for osteoarthritis (OA) affecting the temporomandibular joint (TMJ). Patients with TMJ OA of at least three-month duration and who have not responded to conservative treatments will be included. Patients will be randomly assigned to either high molecular hylan injection or control. At baseline and follow up visits, clinical outcome measures will be assessed such as pain and range of motion. Positive findings in clinical outcome measures will provide evidence for the clinical utility of Synvisc in patients with painful TMJ OA. In addition to clinical outcome measures, a sample of synovial fluid from the affected joint will be obtained at the baseline visit and at 12 week follow up, and levels of tumor necrosis factor alpha (TNF alpha), Matrix metalloproteinase (MMP) and Tissue inhibitor of metalloproteinase (TIMP) will be analyzed. By studying the synovial fluid levels of TNF alpha, MMP and TIMP, we will assess the effects of viscosupplementation with Synvisc on the local inflammatory process and proteolytic activity in TMJ OA in comparison with control treatment. Positive findings in clinical symptoms and synovial fluid analysis will also provide implications of clinical utility of Synvisc in patients with painful TMJ OA. Furthermore, this analysis of synovial fluid may identify biomarkers associated with OA affecting the TMJ.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078351
|United States, Maryland|
|National Institute of Dental And Craniofacial Research (NIDCR)|
|Bethesda, Maryland, United States, 20892|