Clinical and Functional Effectiveness of Botulinum Toxin in Temporomandibular Disorders: A Systematic Review of Randomized Controlled Trials

Abstract

Temporomandibular disorders (TMDs) represent a heterogeneous group of conditions, including myogenous and arthrogenous, with a significant impact on quality of life. Botulinum toxin type A (BoNT-A) has been proposed as a therapeutic option, particularly for patients with refractory myogenous TMD and bruxism. This systematic review aimed to evaluate the clinical effectiveness of BoNT-A in the management of TMDs overall and bruxism, with particular focus on myogenous TMDs compared to placebo and non-surgical treatments. RCTs published between 2020 and 2025 were identified through PubMed, Scopus, and Google Scholar. Overall, 15 RCTs involving 797 participants were included. The available evidence suggests potential benefits of BoNT-A, particularly in patients with localized myofascial pain, myogenous TMD, or marked masticatory muscle hyperactivity. Interpretation of the findings is limited by substantial heterogeneity in treatment protocols, toxin dosage, diagnostic criteria, outcome measures, and follow-up duration. Current evidence does not support the routine use of BoNT-A as a first-line treatment for TMDs overall. Instead, BoNT-A may represent an adjunctive or second-line option for selected patients with myogenous TMD, localized myofascial pain, or marked masticatory muscle hyperactivity who do not adequately respond to conventional noninvasive treatment. Larger and methodologically rigorous RCTs are needed to establish appropriate indications, duration of treatment effects, and long-term safety across different TMD subtypes.