Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism
- Conditions
- Sleep Bruxism
- Interventions
- Drug: Botulinum toxin type A (Meditoxin®)
- Registration Number
- NCT01336439
- Lead Sponsor
- Yonsei University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description M group Botulinum toxin type A (Meditoxin®) A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm. MT group Botulinum toxin type A (Meditoxin®) A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.
- Primary Outcome Measures
Name Time Method The change of bruxism events At 4 weeks after Botulinum toxin type A injection 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.
- Secondary Outcome Measures
Name Time Method The change of masticatory force(%) At 4 weeks after Botulinum toxin type A injection 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?"
The change of Pain At 4 weeks after Botulinum toxin type A injection 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)
Sleep-related breathing disorders At 4 weeks after Botulinum toxin type A injection 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.)
Sleep-related movement disorders At 4 weeks after Botulinum toxin type A injection 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
Trial Locations
- Locations (1)
Yonsei University dental hospital
🇰🇷Seoul, Sedaemun-gu, Korea, Republic of