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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01336439
First Posted: April 15, 2011
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
April 4, 2011
April 15, 2011
April 19, 2011
March 2011
August 2011   (Final data collection date for primary outcome measure)
The change of bruxism events [ Time Frame: 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.

Same as current
Complete list of historical versions of study NCT01336439 on ClinicalTrials.gov Archive Site
  • The change of masticatory force(%) [ Time Frame: 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 [ Time Frame: 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 movement disorders [ Time Frame: 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
  • Sleep-related breathing disorders [ Time Frame: 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.)
Same as current
Not Provided
Not Provided
 
Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism
Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sleep Bruxism
Drug: 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 Name: Meditoxin®(PacificPharm corporation, Korea)
  • Active Comparator: M group
    A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm.
    Intervention: Drug: Botulinum toxin type A (Meditoxin®)
  • Active Comparator: MT group
    A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.
    Intervention: Drug: Botulinum toxin type A (Meditoxin®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
December 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01336439
2-2010-0017
No
Not Provided
Not Provided
Kim Seong Taek, Yonsei University dental hospital
Yonsei University
Not Provided
Study Chair: SeongTaek Kim, PhD Yonsei University dental hospital
Yonsei University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP