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

Primary Purpose

Sleep Bruxism

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A (Meditoxin®)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Bruxism focused on measuring Bruxism, Polysomnography, Botulinum toxin type A, Masseter muscle, Temporal muscle

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University dental hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

M group

MT group

Arm Description

A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm.

A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.

Outcomes

Primary Outcome Measures

The change of bruxism events
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(%)
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
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
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
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.)

Full Information

First Posted
April 4, 2011
Last Updated
April 18, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01336439
Brief Title
Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism
Acronym
BBP
Official Title
Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Bruxism
Keywords
Bruxism, Polysomnography, Botulinum toxin type A, Masseter muscle, Temporal muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M group
Arm Type
Active Comparator
Arm Description
A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm.
Arm Title
MT group
Arm Type
Active Comparator
Arm Description
A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A (Meditoxin®)
Other Intervention Name(s)
Meditoxin®(PacificPharm corporation, Korea)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of bruxism events
Description
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.
Time Frame
At 4 weeks after Botulinum toxin type A injection
Secondary Outcome Measure Information:
Title
The change of masticatory force(%)
Description
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?"
Time Frame
At 4 weeks after Botulinum toxin type A injection
Title
The change of Pain
Description
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)
Time Frame
At 4 weeks after Botulinum toxin type A injection
Title
Sleep-related movement disorders
Description
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
Time Frame
At 4 weeks after Botulinum toxin type A injection
Title
Sleep-related breathing disorders
Description
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.)
Time Frame
At 4 weeks after Botulinum toxin type A injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YoungJoo Shim, M.S.D.
Phone
82-2-2228-8875
Email
yjshim@yuhs.ac
First Name & Middle Initial & Last Name or Official Title & Degree
HyungUk Park, D.D.S.
Phone
82-2-2228-8879
Email
park777@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeongTaek Kim, PhD
Organizational Affiliation
Yonsei University dental hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Yonsei University dental hospital
City
Seoul
State/Province
Sedaemun-gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YoungJoo Shim, M.S.D.
Phone
82-2-2228-8875
Email
yjshim@yuhs.ac
First Name & Middle Initial & Last Name & Degree
HyungUk Park, D.D.S.
Phone
82-2-2228-8879
Email
park777@yuhs.ac

12. IPD Sharing Statement

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

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