Clinical Effectiveness of IncobotulinumtoxinA Using a Standardized Protocol in the Management of Myogenous...

Myogenous temporomandibular disorders (TMDs) are a common subtype of orofacial pain. Evidence regarding treatment with botulinum toxin type A (BoNT-A) remains heterogeneous, and its use is generally limited to refractory cases. This study evaluated 12-month clinical outcomes following an incobotulinumtoxinA protocol (the Ângelo Botulinum Toxin Protocol^®) in adults with DC/TMD-confirmed myogenous TMD unresponsive to conservative therapy.

This retrospective observational study reviewed records from 98 adults treated with incobotulinumtoxinA following the predefined injection protocol. All patients had failed ≥ 3 months of conservative management and completed ≥ 12 months of follow-up. Outcomes included myalgia severity (0-3), patient-reported orofacial pain intensity (VAS 0-10), and maximum mouth opening (MMO). Favorable outcome criteria required myalgia 0-1 or VAS ≤ 2 and MMO ≥ 35 mm.

Myalgia significantly decreased at 12 months (2.69 ± 0.64 to 0.43 ± 0.85; p < 0.001). Patient-reported orofacial pain intensity also improved (2.44 ± 2.54 to 0.37 ± 1.33; p < 0.001). MMO remained stable, indicating preserved mandibular mobility. Overall, 79.6% of patients met the predefined favorable outcome criteria. Reintervention was required in 12 patients; 7 received additional incobotulinumtoxinA injections, and 5 underwent TMJ arthrocentesis. No complications were observed.

This protocol was associated with improvements in muscular pain and orofacial discomfort while preserving mandibular mobility. However, given the retrospective design and absence of a control group, these findings should be interpreted as hypothesis generating.