Approaching temporomandibular disorders from a new direction: a randomized controlled clinical trial of the TMDes ear system.
TMDes (Registered Trademark of Ascentia Health, Inc., Rockford, Illinois), custom-fit ear inserts to aid in reducing temporomandibular disorder (TMD) pain, were evaluated in a prospective, three-month, open-label, three-arm, randomized, unblinded clinical trial, which included patients with TMD diagnoses (RDC/TMD) of myofascial pain, arthralgia, and/or disc displacement with reduction; and a screening VAS pain score of > 4. The three treatment groups included: TMDes (n = 60), stabilization splint (n = 64), and jaw exercise regimen (n = 28). The mean change in Craniomandibular Index (CMI) scores (reductions reflecting improvement) from baseline to one month were -27% (TMDes), -20% (stabilization splint), -12% (jaw exercise regimen), and from baseline to three months were -45%, -41%, -36%, reflecting statistically significant noninferiority (p = 0.0096) of the TMDes to the stabilization splint (primary efficacy endpoint). The TMDes produced significant (p < 0.0001) mean changes in VAS pain scores from baseline of -46% at one month and -58% at three months and demonstrated comparable efficacy and safety to the stabilization splint.
Mexican Institute for Clinical Research (IMIC).
Alejandro Tsuchiya
AT
Tavera
María Cecilia Perrilliat
MC
Montoya
Eduardo Federico Garduño García
EF
Calderón
Gina
G
Gorodezky
Roger N
RN
Wixtrom
D000328:Adult; D018771:Arthralgia / Q000517:prevention & control; D004423:Ear; D005081:Exercise Therapy / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D009209:Myofascial Pain Syndromes / Q000517:prevention & control; D010147:Pain Measurement; D011446:Prospective Studies; D019736:Prostheses and Implants; D013705:Temporomandibular Joint Disorders / Q000517:prevention & control*; D016896:Treatment Outcome