Search / Trial NCT00001955

Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions)

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Jan 18, 2000

Trial Information

Current as of December 26, 2024

Completed

Keywords

Clinical Trial Temporomandibular Joints Celecoxib Etanercept Tumor Necrosis Factor Tmj Tmd

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

  • Celecoxib Study:
  • INCLUSION CRITERIA:
  • Recruitment will include patients with early onset of temporomandibular disorder, whose primary diagnosis consists of anterior disc displacements with reduction as defined by the Research Diagnostic Criteria (RDC).
  • Subjects are required to have preauricular pain for a minimum of one month, a primary TMD diagnosis of TMJ disc displacement, and clinical and radiographic evidence of disc-displacement.
  • EXCLUSION CRITERIA:
  • Subjects who had undergone any TMJ surgery within the preceding 6 months in any active way will be excluded as will those who are taking regularly analgesic, anti-inflammatory, steroids or narcotics medications.
  • Further exclusion criteria will be patients who have any TMJ growth disturbances. Patients with red, hot, swollen, tendered TM joints, or those by medical history consist of infectious arthritis, crystal induced arthropathies, and musculoskeletal disorders will be excluded.
  • Patients will be screened for any positive history of liver or kidney dysfunctions. Patients who have known hypersensitivity to celecoxib, are allergic to sulfonamides, or have demonstrated allergic-type reactions after taking aspirin or other NSAIDs will be excluded.
  • Subjects that have primary psychiatric disease or score above average or higher in comparison with normative scores on Symptom Checklist (SCL-90R) will be able to participate.
  • Subjects with any obvious occlusal disturbances such as cross-bite, open-bite, full dentures will be disqualified.
  • Children under the age of 18 will be excluded from the study.
  • Pregnant women will not be included in the study.
  • Etanercept Study:
  • INCLUSION CRITERIA:
  • For the etanercept study, we will recruitment patients who are in the later stage of temporomandibular disorder, who are not responding to standard non-surgical TMD therapy (i.e., splints, physical therapy, biofeedback, trigger point injections), whose primary diagnosis consists of TMJ osteoarthritis as defined by the Research Diagnostic Criteria.
  • Subjects are required to have preauricular pain for a minimum of three months with clinical and radiographic evidence TMJ arthritis.
  • EXCLUSION CRITERIA:
  • Subjects who had undergone TMJ surgery within the preceding 6 months in any active way will be excluded.
  • Subjects that are taking regularly steroids or narcotics medications will be excluded.
  • Further exclusion criteria will be presence of TMJ growth disturbances. Patients with red, hot, swollen, tendered TM joints, TMJ infections or those with medical history consist of infectious arthritis, crystal induced arthropathies, and musculoskeletal disorders will be disqualified.
  • Patients with sepsis or with known hypersensitivity to etanercept or any of its components will be excluded from the study.
  • Any patients with a medical history of diabetes, congestive heart failure, or any chronic infections will be excluded.
  • Children under the age of 18 will not be included.
  • Pregnant women will not be included.

About National Institute Of Dental And Craniofacial Research (Nidcr)

The National Institute of Dental and Craniofacial Research (NIDCR) is a pivotal component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of dental and craniofacial disorders. Through innovative research and clinical trials, NIDCR aims to enhance oral health and improve the quality of life for individuals affected by these conditions. The institute fosters collaboration among scientists, clinicians, and public health professionals to translate research findings into practical applications, ensuring that the latest advancements benefit patients and communities. With a commitment to excellence in research and education, NIDCR plays a critical role in shaping the future of oral health care.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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