NCT01336439

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 19, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

April 4, 2011

Last Update Submit

April 18, 2011

Conditions

Sleep Bruxism

Keywords

BruxismPolysomnographyBotulinum toxin type AMasseter muscleTemporal muscle

Outcome Measures

Primary Outcomes (1)

  • 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.

    At 4 weeks after Botulinum toxin type A injection

Secondary Outcomes (4)

  • The change of masticatory force(%)

    At 4 weeks after Botulinum toxin type A injection

  • The change of Pain

    At 4 weeks after Botulinum toxin type A injection

  • Sleep-related movement disorders

    At 4 weeks after Botulinum toxin type A injection

  • Sleep-related breathing disorders

    At 4 weeks after Botulinum toxin type A injection

Study Arms (2)

M group

ACTIVE COMPARATOR

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®)

MT group

ACTIVE COMPARATOR

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®)

Interventions

Botulinum toxin type A (Meditoxin®)DRUG

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.

Also known as: Meditoxin®(PacificPharm corporation, Korea)
M groupMT group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University dental hospital

Seoul, Sedaemun-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Sleep BruxismBruxism

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersHabitsBehavior

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • SeongTaek Kim, PhD

    Yonsei University dental hospital

    STUDY CHAIR

Central Study Contacts

YoungJoo Shim, M.S.D.

CONTACT

82-2-2228-8875yjshim@yuhs.ac

HyungUk Park, D.D.S.

CONTACT

82-2-2228-8879park777@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 15, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

April 19, 2011

Record last verified: 2011-03

Locations

KR(1)