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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Sleep Bruxism

Treatments: Drug: Botulinum toxin type A (Meditoxin®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01336439

2-2010-0017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

M group

Active Comparator group

Description:

A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm.

Treatment:

Drug: Botulinum toxin type A (Meditoxin®)

MT group

Active Comparator group

Description:

A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.

Treatment:

Drug: Botulinum toxin type A (Meditoxin®)