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. (Registered at ClinicalTrials.gov: NCT00815776).