Clinical Trial: Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography

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 Summary:

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.


Sponsor: Yonsei University

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.)


Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: April 4, 2011
Date Started: March 2011
Date Completion: December 2011
Last Updated: April 18, 2011
Last Verified: March 2011