Evaluation of the Efficacy of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle for the Treatment of Nocturnal Bruxism: A Randomized Controlled Clinical Trial

Abstract

Introduction Botulinum toxin (Botox®) is considered an effective treatment for nocturnal bruxism when injected into the masseter muscle. Several studies have used different dosages of Botox for this purpose. The objective was to determine whether 10 MU of botulinum toxin type A (BTXA) injections into the masseter muscle could lessen nocturnal bruxism. Material and methods The sample consisted of 22 patients who suffered from pain in the masseter muscle and sensitivity of the teeth as a result of its wear due to nocturnal bruxism. The sample was randomly divided into two groups. The Botox (BO) group included 11 patients injected with 10 MU of BTXA, and the placebo (PL) group included 11 patients who received a sham intervention. Pain perception was assessed on visual analogue scales, whereas muscle activity was recorded by electromyography (EMG) to evaluate the effectiveness of this treatment protocol on nocturnal bruxism. Results A total of 20 patients entered data analysis with one dropout from each group. The differences in the perceived pain values between the BO and the PL groups before and after the injection were statistically significant (p<0.05). In the BO group, the changes in the perceived pain values over time were statistically significant (p<0.05). The pain levels significantly decreased at two weeks, one month, and three months following the injection. However, the levels increased again at the fourth- and sixth-month assessment times with statistically significant differences (p>0.05). The differences in the EMG recorded values were statistically significant between the two groups (p<0.05). Conclusions Within the current study's limitations, injecting 10 MU of BTXA into the masseter muscle reduced muscular activity in this muscle, resulting in decreased muscle spasms and pain symptoms associated with nocturnal bruxism for about three months before symptoms gradually relapsed.

Electromyographic Analysis of Masticatory and Accessory Muscles in Subjects With Implant-Supported Fixed Prostheses: A Three-Arm Comparative Clinical Study

“…EMG activity of masticatory muscles has been extensively studied in both in vivo (using implanted electrodes) and ex vivo (using surface recordings) studies. Using modern surface EMG equipment, scientists can evaluate the performance of several muscles involved in swallowing, chewing, and head orientation (typically the masseter, temporalis anterior and posterior, digastric anterior, and sternocleidomastoid) [ 8 ]. If proper procedures are followed, recorded measurements are reliable in terms of both precision and consistency [ 7 ].…”

Efficacy and Safety of Botulinum Toxin in the Management of Temporomandibular Symptoms Associated with Sleep Bruxism: A Systematic Review

“…The systematic review included a total of nine studies [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ], as summarized in Table 2 . These studies were conducted across various countries, including Saudi Arabia [ 21 , 28 ], Italy [ 22 ], the United States [ 23 , 24 ], South Korea [ 25 , 27 ], Syria [ 26 ], and Australia [ 29 ], over a period spanning from 2010 to 2022.…”

“…The systematic review included a total of nine studies [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 ], as summarized in Table 2 . These studies were conducted across various countries, including Saudi Arabia [ 21 , 28 ], Italy [ 22 ], the United States [ 23 , 24 ], South Korea [ 25 , 27 ], Syria [ 26 ], and Australia [ 29 ], over a period spanning from 2010 to 2022. All selected studies utilized a randomized clinical trial design, focusing on the effects of Botulinum toxin Type A in the treatment of sleep-bruxism-associated TMD symptoms.…”

“…All selected studies utilized a randomized clinical trial design, focusing on the effects of Botulinum toxin Type A in the treatment of sleep-bruxism-associated TMD symptoms. The assessment of study quality revealed a mixture of medium- and high-quality ratings, with most studies being classified as medium quality [ 21 , 24 , 25 , 26 , 27 , 28 ] and three studies [ 22 , 23 , 29 ] receiving a high-quality rating.…”

“…Shim et al [ 25 ] reported discomfort and masticatory difficulties in a significant proportion of their patients, underlining the importance of considering patient comfort and functional outcomes in treatment plans. Shehri et al [ 26 ] noted injection site pain in 20% of participants, a reminder of the need for careful technique and possibly patient counseling on what to expect post-treatment. Cruse et al [ 29 ] found that 22.7% of patients experienced mild and transient side effects, suggesting that while BTX-A treatment is generally well tolerated, patient monitoring and follow-up are essential for managing and mitigating adverse effects.…”