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

NCT01336439 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-04-19

No results posted yet for this study

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.

Conditions

  • Sleep Bruxism

Interventions

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • SeongTaek Kim, PhD · Yonsei University dental hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-08-31
Completion
2011-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336439 on ClinicalTrials.gov