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Synvisc to Treat Osteoarthritis of the Temporomandibular Joint
NCT00078351 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE High molecular weight hylan (Synvisc) injection
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2004-02 |
| Est. Completion | 2005-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078351
The ClinicalTrials.gov registry entry for NCT00078351 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 1 intervention — of which High molecular weight hylan (Synvisc) injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00078351 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00078351 about?
NCT00078351 is a clinical study titled "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 flui...
What is the current status of trial NCT00078351?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2004-02. Estimated completion is 2005-10.
What conditions does trial NCT00078351 study?
This clinical trial studies the following conditions: Osteoarthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00078351?
The interventions under investigation include: High molecular weight hylan (Synvisc) injection (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00078351?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00078351 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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