Approaching temporomandibular disorders from a new direction: a randomized controlled clinical trial of the TMDes ear system.
ABSTRACT 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.