Clinical trial NCT01336439: Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism
Official title: Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Bruxism
Keywords: Bruxism
Polysomnography
Botulinum toxin type A
Masseter muscle
Temporal muscle
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of bruxism events
timeFrame: At 4 weeks after Botulinum toxin type A injection
Secondary outcomes:
measure: The change of masticatory force(%)
timeFrame: At 4 weeks after Botulinum toxin type A injection
measure: The change of Pain
timeFrame: At 4 weeks after Botulinum toxin type A injection
measure: Sleep-related movement disorders
timeFrame: At 4 weeks after Botulinum toxin type A injection
measure: Sleep-related breathing disorders
timeFrame: At 4 weeks after Botulinum toxin type A injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University dental hospital
state: Sedaemun-gu
Study officials:
affiliation: Yonsei University dental hospital
name: SeongTaek Kim, PhD
role: STUDY_CHAIR
References: