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Diagnostic arthroscopy versus arthrocentesis as initial treatment for arthralgia of the temporomandibular joint

Recruiting
Conditions
Arthralgia, internal derangement and degenerative joint disease (i.e. osteoarthritis) of the temporomandibular joint
Registration Number
NL-OMON20171
Lead Sponsor
MCG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
140
Inclusion Criteria

Patients aged > 18 years

- Arthralgia of the TMJ, proven with a diagnostic intra-articular injection with Ultracain DS Forte (articaine 4% + 1:100.000 adrenalin; Aventis Pharma, Hoevelaken, The Netherlands).

- TMJ pain still present after two weeks of NSAIDs (i.e. diclofenac 3 times daily 50mg)

- Symptoms presenting unilaterally or bilaterally with a maximal Visual Analog Scale (VAS)-score < 30 mm during movement or function of the contralateral joint, after anesthetizing the to be treated joint (thus avoiding the contralateral joint to be the cause of a limited mouth opening).

Exclusion Criteria

- Systemic rheumatic disease (such as rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, Sjögren syndromes, psoriatic arthritis)

- Connective tissue disease (such as Marfan syndrome, Ehlers-Danlos syndrome, Osteogenesis Imperfecta)

- Bony ankylosis of the TMJ

- Congenital or acquired dentofacial deformity

- History of jaw trauma that resulted in jaw or joint pain, bony changes or mandibular growth restriction

- Prior arthrocentesis, (diagnostic) arthroscopy or open-TMJ surgery

- Psychiatric disorder (as diagnosed by a physician)

- Unwillingness to receive one of the study treatments

- Pregnancy at time of treatment

- Concurrent use of steroids, sedatives, muscle relaxants or anti-inflammatory drugs other than the previously prescribed NSAIDs

- Incompetence to speak the Dutch or English language

- Medical comorbidities such as coagulation disorders, diabetes mellitus type I or II, kidney failure, heart failure, cardiac ischemia, hypertension and history of HIV.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain perceived by the patient during mandibular movement or function using the Visual Analogue Scale (VAS; ranging 0-100mm).
Secondary Outcome Measures
NameTimeMethod
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