Combined Effects of Botulinum Toxin Injection and Oral Appliance Therapy on Lower Facial Contouring: A Randomized Controlled Trial.

ABSTRACT

(1) Background: Botulinum toxin (BoNT) injection is an esthetically effective and safe treatment for contouring the lower face. This study aimed to evaluate the combined effects of BoNT and supplementary oral appliance (OA) therapy on lower facial contouring. (2) Methods: We conducted a prospective randomized controlled trial from January 2015 to June 2016 at the Yonsei University Dental Hospital. Volunteers aged 20−45 years with masseter hypertrophy were randomly assigned to one of two groups the non-OA group and the OA group. The non-OA group received BoNT injections alone, whereas the OA group received an OA in addition to BoNT injections. Changes in the bulkiest height of the lower face were evaluated by three-dimensional laser scanning before and 4, 8, 12, and 24 weeks after injections in both groups. (3) Results: In both groups, the bulkiest height reductions decreased, with a significant interaction between group (p = 0.046) and time (p < 0.001), although the overall reduction was at a similar level at 24 weeks. (4) Conclusions: The pattern of the bulkiest height reduction of the lower face after BoNT injection differed between standalone treatment and OA therapy, implying a normalizing effect of OA on masseter muscle activity.