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

April 18, 2011 updated by: Yonsei University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: YoungJoo Shim, M.S.D.
  • Phone Number: 82-2-2228-8875
  • Email: yjshim@yuhs.ac

Study Contact Backup

  • Name: HyungUk Park, D.D.S.
  • Phone Number: 82-2-2228-8879
  • Email: park777@yuhs.ac

Study Locations

  • Korea, Republic of
    • Sedaemun-gu
      • Seoul, Sedaemun-gu, Korea, Republic of
        • Recruiting
        • Yonsei University Dental Hospital
        • Contact:
          • YoungJoo Shim, M.S.D.
          • Phone Number: 82-2-2228-8875
          • Email: yjshim@yuhs.ac
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Meditoxin®(PacificPharm corporation, Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 4 weeks after Botulinum toxin type A injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
At 4 weeks after Botulinum toxin type A 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)
At 4 weeks after Botulinum toxin type A injection
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
At 4 weeks after Botulinum toxin type A injection
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.)
At 4 weeks after Botulinum toxin type A injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Study Chair: SeongTaek Kim, PhD, Yonsei University Dental Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-2010-0017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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