Arthropathy of the temporomandibular joint MedDRA version: 9.1 Level: LLT Classification code 10003285 Term: Arthropathy
Conditions
Interventions
Trade Name: Brufen Bruis
Pharmaceutical Form: Powder for oral suspension
Sponsors
UMCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with pain in the TMJ, suspected for a TMJ intra-articular disorder. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Complete disappearence of complaints after using NSAID (Ibuprofen, 3dd 600mg 14 days) - Negative respond to this aesthesia of the TMJ - Bony ankylosis of the TMJ - Reumatoid arthritis - History of an open TMJ surgery - Incompetence to speak the Dutch or English language - Age under 18 years - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy of arthrocentesis as initial treatment of arthropathy for reduction of pain and the restoration of mandibular function as compared to usual care.;Secondary Objective: An economic evaluation will be conducted alongside the clinical study to assess the cost-effectiveness of arthrocentesis in patients with arthropathy of the TMJ.;Primary end point(s): Main outcome measure is pain in the TMJ (0 – 100 mm VAS) | — |
Countries
Netherlands
Outcome results
None listed