drugset / Trial / NCT01275014

Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis

NCT01275014 ↗

Phase 4 Unknown 28 enrolled University Medical Center Groningen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ). Twenty-eight participants with TMJ arthralgia, mainly related to osteoarthritis ae randomly assigned to two arms of a parallel double blind RCT. In both arms an arthrocentesis procedure is carried out, while a single dose intraarticular dexamethasone was delivered to participants in one arm. Saline was delivered in the other arm to serve as a control. Follow up visits were scheduled after 1, 3 and 24 weeks. During each visit TMJ pain (on a 100mm VAS) and joint stiffness (mouth opening in mm) are scored. Generalized estimating equations (GEE) are used for statistical analysis.

Timeline

Start
2008-12
Primary completion
2010-12
Completion
2010-12

Outcome

Missed primary endpoint

paper In conclusion, intra-articular dexamethasone following arthrocentesis did not improve the procedure's effect in patients presenting with TMJ arthralgia PMID 22157100 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Other