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NCT00078351 · ClinicalTrials.gov registry record · Phase 2
Synvisc to Treat Osteoarthritis of the Temporomandibular Joint
A Phase 2 study of Osteoarthritis, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00078351 is a Phase 2 study of Osteoarthritis that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 60 participants, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00078351, a Phase 2 study of Osteoarthritis, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (93% lower). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
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.
NCT00078351 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
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.
What interventions are being tested in trial NCT00078351?
The interventions under investigation include: High molecular weight hylan (Synvisc) injection (PROCEDURE).
Who is sponsoring clinical trial NCT00078351?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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