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The Role of Cytokines as Inflammatory Mediators in Painful Temporomandibular Joints

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Qué se está evaluando

Etanercept

+ Celecoxib

Medicamento
Quiénes están siendo reclutados

Enfermedades de la Mandíbula+4

+ Enfermedades de las Articulaciones

+ Enfermedades de la Mandíbula

Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: diciembre de 1999
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Dental and Craniofacial Research (NIDCR)
Última actualización: 4 de marzo de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de diciembre de 1999

Fecha en la que se inscribió al primer participante.

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 will be assessed at base line and after 6-week follow-up. Successful demonstration of an enhanced therapeutic effect or reduced toxicity may provide a basis for clinical use of selective COX-2 inhibitors in patients with painful TMD. In a second group of carefully selected patients, we will evaluate the short-term effect etanercept (Enbrel) in comparison to placebo in patients who had pain and tenderness to palpation in the temporomandibular joint (TMJ osteoarthritis) of at least three month duration and who had not responded to conservative treatment. Etanercept is a biologic modifier that binds specifically to tumor necrosis factor alpha (TNF alpha). The mechanism of action of etanercept is competitive inhibition of TNF binding to cell-surface TNF receptors (TNFR), preventing TNF-mediated cellular responses by rendering TNF biologically inactive. Subjects will be randomly assigned to either etanercept or placebo administration. At baseline and at 6-week follow up individual outcomes will be assessed such as pain, mandibular range of motion along with the analysis of the sample synovial fluid level of TNF alpha. By studying the joint fluid levels of TNF alpha, we will learn more about the development of the local inflammatory process in the joint, which will help in predicting the prognosis for patients with these TM joint disorders. Positive findings will also provide clinical implications of etanercept in patients with painful TMJ osteoarthritis.

NCT00001955
Patrocinador PrincipalNational Institute of Dental and Craniofacial Research (NIDCR)
Última actualización: 4 de marzo de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 150 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades de la MandíbulaEnfermedades de las ArticulacionesEnfermedades de la MandíbulaEnfermedades EstomatognáticasEnfermedades MuscularesEnfermedades del sistema musculoesqueléticoTrastornos de la Articulación Temporomandibular

Criterios

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.

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, United StatesAbrir National Institute of Dental And Craniofacial Research (NIDCR) en Google Maps
Completado1 Centros de Estudio