drugset / Trial / NCT01770912

Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

NCT01770912

Phase 2 Completed 24 enrolled University of Florida
RandomizedParallel-groupTriple-blindTreatment

Summary

The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment. All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.

Timeline

Start
2013-03
Primary completion
2019-01-24
Completion
2019-01-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Triamcinolone Hexacetonide Other / unclassified 5 mg Other

Indications

No indication recorded.