This study assessed the safety and efficacy of three different doses of BoNT-A for persistent myofascial pain (MFP). One hundred female subjects were randomly assigned into five groups (n = 20): oral appliance (OA), saline solution (SS) and three BoNT-A groups with different doses. Pain intensity and pressure pain threshold were evaluated up to 24 weeks after treatment. Adverse effects related to muscle contraction, masticatory performance, muscle thickness and mandibular bone volume were also assessed. Changes over time were compared within and between groups. The “nparLD” package and Wilcoxon signed-rank test were used to analyze the data. BoNT-A reduced pain intensity (p < 0.0001) and increased pressure pain threshold (p < 0.0001) for up to 24 weeks compared to the placebo. No differences were found between BoNT-A and OA at the last follow-up. A transient decline in masticatory performance (p < 0.05) and muscle contraction (p < 0.0001), and a decrease in muscle thickness (p < 0.05) and coronoid and condylar process bone volume (p < 0.05) were found as dose-related adverse effects of BoNT-A. Regardless of the dose, BoNT-A was as effective as OA on MFP. Notwithstanding, due to BoNT-A dose-related adverse effects, we suggest the use of low doses of BoNT-A in MFP patients that do not benefit from conservative treatments.

Botulinum toxins (BoNTs) are a product of the bacteria Clostridium botulinum. By entering nerve endings, they cleave and inactivate SNARE proteins, which are essential for neurotransmitter release. Prevention of acetylcholine release at the neuromuscular junction causes long-lasting and potentially fatal flaccid paralysis—a major feature of botulism. However, an intramuscular injection of minute amounts of BoNTs, primarily type A (BoNT-A), has useful long-lasting muscle relaxation effects on spastic motor disorders. This characteristic of BoNT-A is widely used in neurology and cosmetics. Over the last few decades, it has been demonstrated that the functions of BoNT-A are not limited to muscle-relaxing or autonomic cholinergic effects but that it can act as an analgesic agent as well. More recently, it was revealed that this antinociceptive effect starts after entering the sensory nerve endings, where these agents are axonally transported to the central nervous system, suggesting that at least part of their analgesic effect might be of central origin. Because of its antinociceptive effect, BoNT-A is currently approved for treatment of chronic migraine; nonetheless, case reports and preclinical and clinical experiments indicating its benefit in numerous potential painful conditions have increased. In the field of dentistry, the US Food and Drug Administration approved BoNT-A for the treatment of sialorrhea only. Legal status of the use of BoNT-A in other countries is less known. However, there are controlled clinical trials suggesting its efficacy in other conditions, such as bruxism, temporomandibular disorders, and trigeminal neuropathic pain. Thereby, using criteria of the American Academy of Neurology, we critically reviewed the uses of BoNTs in oral medicine and found it effective for trigeminal neuralgia (category A) and probably effective in temporomandibular disorders and bruxism.

The prevalence of temporomandibular disorders (TMD) is higher in females, reaching their high peak during reproductive years, probably because of the action of some female hormones, which alter pain threshold. This study aimed to investigate the prevalence of TMD in postmenopausal women and its relationship with pain and hormone replacement therapy (HRT). In total, 284 patients were evaluated and classified using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Pain was measured using the Visual Analogue Scale (VAS), and patients were also asked about the use of HRT. All data was analyzed using analysis of variance (ANOVA) and chi-square test. In total, 155 subjects did not have TMD and 129 had TMD; TMD group patients were classified according to RDC/TMD axis I classification as follows: muscle disorder group (1.6%), disk displacement group (72.87%), and arthralgia, osteoarthritis, and osteoarthrosis group (37.98%). Pain was registered in 35 patients who belonged to the TMD group, while 48 patients reported the use of HRT. There was a similar percentage of TMD and non TMD patients; moreover, the use of exogenous hormones was no associated with TMD, suggesting that there is no influence on the pain threshold.