Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography

Conditions
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Sleep Bruxism

Intervention / Treatment
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* Drug: Botulinum toxin type A (Meditoxin®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of sleep bruxism confirmed by wear facets on occlusal splint must be able to follow clinical trial procedure who are suitable for this clinical trial who participated in this clinical trial out of his own free will Exclusion Criteria: who take medications such as benzodiazepine or muscle relaxants who have secondary bruxism due to brain injury who are pregnant or have the possibility of pregnancy who had an botulinum toxin injection during the past three months who had an allergic reaction history to botulinum toxin who have an infection or skin trouble on injection site who have an other treatment plan for bruxism who are enrolled in other clinical trials who are not suitable for this clinical trials who have mandibular dyskinesia or mandibular dystonia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M group<br>A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm. | Drug: Botulinum toxin type A (Meditoxin®)<br>* In this study, the botulinum toxin type A (Meditoxin®)was supplied as a freeze-dried powder of 200U, and was reconstituted with 4ml of sterile saline to a concentration of 5U/0.1ml. After pre-injection polysomnography, botulinum toxin type A was injected into each side bilaterally using a 1ml-syringe with a 29-gauge, and a 1/2-inch needle. The M group had an injection in masseter muscle. The MT group had an injection in masseter and temporal muscle. A total of 25U of botulinum toxin type A was injected into each site. After 4 weeks, the subjects had a post-injection polysomnography.<br>* Other names: Meditoxin®(PacificPharm corporation, Korea);|
| Active Comparator: MT group<br>A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm. | Drug: Botulinum toxin type A (Meditoxin®)<br>* In this study, the botulinum toxin type A (Meditoxin®)was supplied as a freeze-dried powder of 200U, and was reconstituted with 4ml of sterile saline to a concentration of 5U/0.1ml. After pre-injection polysomnography, botulinum toxin type A was injected into each side bilaterally using a 1ml-syringe with a 29-gauge, and a 1/2-inch needle. The M group had an injection in masseter muscle. The MT group had an injection in masseter and temporal muscle. A total of 25U of botulinum toxin type A was injected into each site. After 4 weeks, the subjects had a post-injection polysomnography.<br>* Other names: Meditoxin®(PacificPharm corporation, Korea);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of bruxism events | Before and after injection, we compared the change of bruxism event in polysomnography by sleep laboratory criteria. <Sleep laboratory criteria> - Mean SB EMG potential : >10% or 20% of the maximal clench while awake (masseter muscles) In M group, Botulinum toxin was injected into masseter muscle. In TM group, Botulinum toxin was injected into masseter muscle and temporal muscle. | At 4 weeks after Botulinum toxin type A injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of masticatory force(%) | We evaluated the change of subjective masticatory force before and after the injection. We asked the subject that when the masticatory force before injection is represented 100%, what the masticatory force after injection? | At 4 weeks after Botulinum toxin type A injection | 
| The change of Pain | We asked the subject about change of pain if the subject has pain on masseter muscle due to myogeneous problem. Pain score was chosen from a scale of zero to 10, where zero represented 'no pain' and 10 represented 'the worst pain they had ever experienced' (Numerical rating scale, NRS) | At 4 weeks after Botulinum toxin type A injection | 
| Sleep-related movement disorders | The percentage of subjects who have sleep-related movement disorders(ex, Restless Legs Syndrome, Periodic Limb Movement Disorder, Sleep Related Leg Cramps, Sleep Related Rhythmic Movement Disorder Sleep Related Movement Disorder, Unspecified)except sleep related bruxism | At 4 weeks after Botulinum toxin type A injection | 
| Sleep-related breathing disorders | The percentage of subjects who have sleep-related breathing disorders(ex, Obstructive Sleep apnoea, Sleep Related Hypoventilation/Hypoxaemic syndromes, sleep Related Non-obstructive Alveolar Hypoventilation(idiopathic), Sleep apnoea/Sleep Related Breathing Disorder, Unspecified and etc.) | At 4 weeks after Botulinum toxin type A injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bruxism, Polysomnography, Botulinum toxin type A, Masseter muscle, Temporal muscle