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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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