Clinical study overview of the Cerezen™ ear canal inserts
With respect to the primary efficacy endpoint, Cerezen™ inserts demonstrated statistically significant non-inferiority to the stabilization splint in the reduction of the CMI score from baseline to 3 months (p=0.0096). Statistically significant reductions from baseline in TMJ pain, as assessed by in-office VAS (visual analog scale) scores, were also demonstrated for the Cerezen™ ear canal inserts (see Figure below), with a 46% reduction at 1 month (p<0.0001), 51% reduction at 2 months (p<0.0001), and a 58% reduction at 3 months (p<0.0001). Such results supported the label claim for the Cerezen™ inserts as being "indicated as an aid in reducing temporomandibular joint disorder (TMJD) pain."
* Tavera A, et al: Approaching Temporomandibular Disorders From a New Direction: A Randomized Controlled Clinical Trial of the TMDes Ear System. J Craniomandibular Practice July 2012; Vol 30, No. 3, 172-181
Patient global satisfaction in the pivotal clinical trial was extremely high, with 100% of subjects in the Cerezen™ inserts group indicating excellent (71%) or good (29%) overall satisfaction with the devices. In summary, in the pivotal clinical trial, inserts demonstrated comparable efficacy and safety to the stabilization splint, a recognized standard of care and the most widely used current TMJ treatment.