<b>OBJECTIVES: </b>To test the safety and efficacy of onabotulinum toxin-A (BoNT-A) injections into the masseter and temporalis muscles in patients with symptomatic sleep bruxism.<b>METHODS: </b>Participants 18 to 85 years old with clinically diagnosed sleep bruxism confirmed by polysomnography were enrolled in this randomized, placebo-controlled, 1:1, parallel-design trial with open-label extension. Participants were injected with BoNT-A 200 units (60 into each masseter and 40 into each temporalis) or placebo and were evaluated at 4 to 8 weeks after the initial treatment visit. The primary efficacy endpoint was clinical global impression (CGI), and the secondary efficacy endpoint was a visual analog scale (VAS) of change in bruxism and in pain at 4 to 8 weeks after injection. Exploratory endpoints included modified Montreal Bruxism Questionnaire, Headache Impact Test-6, total Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Self-Rated Anxiety Scale, and polysomnography data, including EMG recordings of the masseter and temporalis muscle bruxing events. Adverse events were recorded.<b>RESULTS: </b>Thirty-one participants were recruited and 23 were randomized (19 female, age 47.4 ± 16.9 years). All 13 randomized to BoNT-A and 9 of 10 randomized to placebo completed the study. CGI (p < 0.05) and VAS of change (p < 0.05) favored the BoNT-A group. None of the exploratory endpoints changed significantly, but total sleep time and number/duration of bruxing episodes favored the BoNT-A group. Two participants randomized to BoNT-A reported a cosmetic change in their smile. No dysphagia or masticatory adverse events were reported.<b>CONCLUSIONS: </b>BoNT-A effectively and safely improved sleep bruxism in this placebo-controlled pilot trial. A large multicenter trial is needed to confirm these encouraging data.<b>Clinicaltrialsgov Identifier: </b>NTC00908050.<b>Class Of Evidence: </b>This study provides Class II evidence that botulinum injections into the masseter and temporalis muscles improve subjective bruxism and painful symptoms associated with sleep bruxism.
<b>Aim and OBJECTIVE: </b>The present study was conducted in patients with bruxism to evaluate the effect of botulinum toxin type A (BTX-A) (Botox, Allergan, Inc., Irvine, CA, USA) in the treatment of myofascial pain and the occlusal force characteristics of masticatory muscles.<b>MATERIALS AND METHODS: </b>Twenty-four diagnosed with bruxism were randomly divided into three groups (n = 8) and treated by bilateral intramuscular injection of BTX-A and placebo-treated with saline placebo injections and control group where no injections were given. The clinical parameters such as pain at rest and during chewing were assessed and occlusal force analysis system to measure the distribution of occlusal force in bruxism patients. All the three groups were assessed at baseline time and at 1 week, 3 months, and 6 months follow-up appointments. Descriptive analysis showed that improvements in parameters such as pain at rest; pain during chewing clinical outcome variables were higher in the botox treated group than in the placebo-treated subjects.<b>RESULTS: </b>The pain at rest and at chewing decreased in the BTX-A group while remaining constant in the placebo group and control group. There was a significant change in maximum occlusal force in the BTX-A group compared with the other two groups (P < 0.05, post hoc Bonferroni test, no exact P value), and there was no significant difference between the placebo and control groups (post hoc Bonferroni test, no exact P value).<b>CONCLUSION: </b>Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and effective in reducing the occlusal force.
OBJECTIVE: To evaluate the effect of botulinum toxin type A on nocturnal bruxism. DESIGN: Twelve subjects reporting nocturnal bruxism were recruited for a double-blind, randomized clinical trial. Six bruxers were injected with botulinum toxin in both masseters, and six with saline. Nocturnal electromyographic activity was recorded in the subject's natural sleeping environment from masseter and temporalis muscles before injection, and 4, 8, and 12 wks after injection and then used to calculate bruxism events. Bruxism symptoms were investigated using questionnaires. RESULTS: Bruxism events in the masseter muscle decreased significantly in the botulinum toxin injection group (P = 0.027). In the temporalis muscle, bruxism events did not differ between groups or among times. Subjective bruxism symptoms decreased in both groups after injection (P < 0.001). CONCLUSIONS: Our results suggest that botulinum toxin injection reduced the number of bruxism events, most likely mediated its effect through a decrease in muscle activity rather than the central nervous system. We controlled for placebo effects by randomizing the interventions between groups, obtaining subjective and objective outcome measures, using the temporalis muscle as a control, and collecting data at three postinjection times. Our controlled study supports the use of botulinum toxin injection as an effective treatment for nocturnal bruxism.
<b>PURPOSE: </b>To evaluate the effects of botulinum toxin-A in the treatment of patients who have myofascial pain with or without functional disc displacement. <b>Patients and METHODS: </b>Twenty-four participants were randomly assigned to the study by using Research Diagnostic Criteria for Temporomandibular Disorders. All patients were informed about botulinum toxin-A, and were required to give informed consent. Before the injections, patients were asked to fill out a Biobehavioral Questionnaire to evaluate their pain and psychological status, and afterward, electromyography of the right and left masseter and anterior temporal muscles was recorded. Saline was injected into the masseter and anterior temporal muscles in the placebo group, and botulinum toxin-A was used in the study group. On days 14 and 28, patients were asked to fill out a Biobehavioral Questionnaire again, and electromyography of the right and left masseter and anterior temporal muscles was recorded again. <b>RESULTS: </b>The study group showed improvement in pain and psychological status. Although a decrease in the action potentials of the masseter muscles on day 14 was followed by an increase on day 28, the reduction of pain scores and improvement in psychological status continued on day 28. <b>CONCLUSIONS: </b>The injection of botulinum toxin-A decreases the muscle action potential in 14 days. The patients also show improvement in pain and psychological status.
To test the safety and efficacy of onabotulinum toxin-A (BoNT-A) injections into the masseter and temporalis muscles in patients with symptomatic sleep bruxism.
METHODS:
Participants 18 to 85 years old with clinically diagnosed sleep bruxism confirmed by polysomnography were enrolled in this randomized, placebo-controlled, 1:1, parallel-design trial with open-label extension. Participants were injected with BoNT-A 200 units (60 into each masseter and 40 into each temporalis) or placebo and were evaluated at 4 to 8 weeks after the initial treatment visit. The primary efficacy endpoint was clinical global impression (CGI), and the secondary efficacy endpoint was a visual analog scale (VAS) of change in bruxism and in pain at 4 to 8 weeks after injection. Exploratory endpoints included modified Montreal Bruxism Questionnaire, Headache Impact Test-6, total Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Self-Rated Anxiety Scale, and polysomnography data, including EMG recordings of the masseter and temporalis muscle bruxing events. Adverse events were recorded.
RESULTS:
Thirty-one participants were recruited and 23 were randomized (19 female, age 47.4 ± 16.9 years). All 13 randomized to BoNT-A and 9 of 10 randomized to placebo completed the study. CGI (p < 0.05) and VAS of change (p < 0.05) favored the BoNT-A group. None of the exploratory endpoints changed significantly, but total sleep time and number/duration of bruxing episodes favored the BoNT-A group. Two participants randomized to BoNT-A reported a cosmetic change in their smile. No dysphagia or masticatory adverse events were reported.
CONCLUSIONS:
BoNT-A effectively and safely improved sleep bruxism in this placebo-controlled pilot trial. A large multicenter trial is needed to confirm these encouraging data.Clinicaltrialsgov Identifier: NTC00908050.Class Of Evidence: This study provides Class II evidence that botulinum injections into the masseter and temporalis muscles improve subjective bruxism and painful symptoms associated with sleep bruxism.
