Synvisc to Treat Osteoarthritis of the Temporomandibular Joint
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00078351|
Recruitment Status : Completed
First Posted : February 24, 2004
Last Update Posted : March 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: High molecular weight hylan (Synvisc) injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078351
|United States, Maryland|
|National Institute of Dental And Craniofacial Research (NIDCR)|
|Bethesda, Maryland, United States, 20892|