Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
Completed · Phase 2
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01770912
- Run by
- University of Florida
- People needed
- 24
- Starts
- 2013-03-01
- Expected to finish
- 2019-01-24
- Last updated by the study team
- 2020-10-08
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- 18-80 years of age
- TMJ arthralgia
- Masticatory myalgia
- TMJ sounds
- History of at least 6 weeks use of occlusal appliance therapy
You may not qualify if…
- Contraindication to sedation including pregnancy or medical history
- History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
- History of steroidal injection into TMJ
- History of trauma to TMJ
- TMJ pain longer than 3 years
- History of narcotic drug use on a scheduled basis
- Current active infection
Where it is running
- University of Florida College of Dentistry — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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