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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01336439
First received: April 4, 2011
Last updated: April 18, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Sleep Bruxism
Drug: Botulinum toxin type A (Meditoxin®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The change of bruxism events [ Time Frame: At 4 weeks after Botulinum toxin type A injection ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • The change of masticatory force(%) [ Time Frame: At 4 weeks after Botulinum toxin type A injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.)


Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: M group
A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm.
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: MT group
A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.
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)

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336439

Contacts
Contact: YoungJoo Shim, M.S.D. 82-2-2228-8875 yjshim@yuhs.ac
Contact: HyungUk Park, D.D.S. 82-2-2228-8879 park777@yuhs.ac

Locations
Korea, Republic of
Yonsei University dental hospital Recruiting
Seoul, Sedaemun-gu, Korea, Republic of
Contact: YoungJoo Shim, M.S.D.    82-2-2228-8875    yjshim@yuhs.ac   
Contact: HyungUk Park, D.D.S.    82-2-2228-8879    park777@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: SeongTaek Kim, PhD Yonsei University dental hospital
  More Information

No publications provided

Responsible Party: Kim Seong Taek, Yonsei University dental hospital
ClinicalTrials.gov Identifier: NCT01336439     History of Changes
Other Study ID Numbers: 2-2010-0017
Study First Received: April 4, 2011
Last Updated: April 18, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Bruxism
Polysomnography
Botulinum toxin type A
Masseter muscle
Temporal muscle

Additional relevant MeSH terms:
Sleep Bruxism
Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014