Terminé

The Role of Cytokines as Inflammatory Mediators in Painful Temporomandibular Joints

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Ce qui est testé

Etanercept

+ Celecoxib

Médicament
Qui peut participer

Maladies de la mâchoire+5

+ Maladies des Articulations

+ Maladies mandibulaires

Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Date de début : décembre 1999
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Dental and Craniofacial Research (NIDCR)
Dernière mise à jour : 4 mars 2008
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 décembre 1999

Date à laquelle le premier participant a commencé l'étude.

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
Sponsor principalNational Institute of Dental and Craniofacial Research (NIDCR)
Dernière mise à jour : 4 mars 2008
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

150 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies de la mâchoireMaladies des ArticulationsMaladies mandibulairesMaladies stomatognathiquesMaladies musculairesMaladies musculo-squelettiquesTroubles CraniomandibulairesTroubles de l'articulation temporomandibulaire

Critères

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.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, United StatesOuvrir National Institute of Dental And Craniofacial Research (NIDCR) dans Google Maps
Terminé1 Centres d'Étude