Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism
NCT ID: NCT01336439
Last Updated: 2011-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
24 participants
INTERVENTIONAL
2011-03-31
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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M group
A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm.
Botulinum toxin type A (Meditoxin®)
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.
MT group
A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.
Botulinum toxin type A (Meditoxin®)
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.
Interventions
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Botulinum toxin type A (Meditoxin®)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
65 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Yonsei University dental hospital
Principal Investigators
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SeongTaek Kim, PhD
Role: STUDY_CHAIR
Yonsei University dental hospital
Locations
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Yonsei University dental hospital
Seoul, Sedaemun-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2-2010-0017
Identifier Type: -
Identifier Source: org_study_id
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