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

Sleep Bruxism Clinical Trial

— BBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01336439
• Other study ID #: 2-2010-0017
• Status: Recruiting
• Phase: Phase 4
• First received: April 4, 2011
• Last updated: April 18, 2011
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: Yonsei University
• Contact: YoungJoo Shim, M.S.D.
• Phone: 82-2-2228-8875
• Email: yjshim[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University dental hospital	Seoul	Sedaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of bruxism events	Before and after injection, we compared the change of bruxism event in polysomnography by 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.	At 4 weeks after Botulinum toxin type A injection	No
Secondary	The change of masticatory force(%)	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?"	At 4 weeks after Botulinum toxin type A injection	No
Secondary	The change of Pain	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)	At 4 weeks after Botulinum toxin type A injection	No
Secondary	Sleep-related movement disorders	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	At 4 weeks after Botulinum toxin type A injection	No
Secondary	Sleep-related breathing disorders	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.)	At 4 weeks after Botulinum toxin type A injection	No