Sleep Bruxism Clinical Trial
Official title:
Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography
The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on bruxism using polysomnography and determine which site is most appropriate for injection to obtain maximal effects.
Bruxism is an oral habit consisting of involuntary non-functional gnashing, clenching,
grinding of teeth and is a very common condition in the general population. Various
treatment modalities such as occlusal splints, pharmacologic agent and cognitive-behavioral
therapy have been investigated for the management of bruxism, but none is reported to be
fully effective. Recently locally injected botulinum toxin has been used in various movement
disorders, but its usefulness and objective effects on nocturnal bruxism have not been
evaluated using objective measures such as polysomnography. Moreover, there is no systematic
study about which site is most appropriate for injection to obtain maximal effects.
The aim of this study is to evaluate the effect of botulinum toxin type A into masseter
muscle or both masseter muscle and temporal muscle on nocturnal bruxism using
polysomnography and the changes in the bruxism events on polysomnography.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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