Clinical investigation of botulinum toxin (prabotulinumtoxin A) for bruxism related to masseter muscle hypertrophy: A prospective study.

This study aims to confirm the effectiveness and safety of a prabotulinumtoxin type A (praBTX-A) injection in patients with bruxism and masseter hypertrophy. The study included patients who ground or clenched their teeth while sleeping and had computed tomography (CT) scans that showed a maximum thickness of the masseter muscle of 15 mm or more. The praBTX-A was administered bilaterally into the masseter muscles; 15 U/side for group 1, 25 U/side for group 2, and 35 U/side for group 3. CT scans and bruxism questionnaires were conducted before and eight weeks after the injection. Thirty-seven patients were enrolled, but three dropped out due to loss of follow-up. After injection, masseter thickness decreased to 15.1 ± 2.0 mm for group 1, 14.3 ± 2.9 mm for group 2, and 13.4 ± 1.8 mm for group 3 (p = 0.043). Group 3 showed a statistically significant lower masseter thickness compared to group 1 (p = 0.039). Both subjective and objective frequencies of bruxism decreased for all groups, but there were no significant differences in either subjective (p = 0.396) or objective frequencies (p = 0.87) between the groups after the injection. The results of this study suggest that praBTX-A injection is a safe and effective treatment for bruxism and masseter hypertrophy. A dosage of 35 IU/side can effectively decrease masseter thickness and relieve bruxism symptoms. Even the minimum dosage of 15 IU/side can contribute to improvements in bruxism symptoms. This investigation provides valuable information for managing bruxism that is associated with hypertrophic masseter muscles.