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Clinical Trial Summary

The purpose of this study is to test whether severe masticatory muscle spasms during sleep (e.g. teeth clenching and grinding, known as "bruxism" in technical jargon) demonstrably decrease after application of botulinum toxin type A (Xeomin®). Xeomin® has so far been used to relieve spasms of other muscles and is an approved drug in Switzerland. This study is now intended to test the suitability of this drug for relaxation of the masseter muscle.


Clinical Trial Description

Bruxism is a prevalent condition that differentially burdens individuals. The overall objective of this pilot study is to measure the effects of BTX-A (Xeomin®) injections into bilateral masseter muscles for the management of sleep bruxism and associated symptoms. The hypothesis is that BTX-A reduces masticatory muscle activity. The aim of this study is to instrumentally monitor subjects closely over an extended time period of three months before and after application of BTX-A. Botulinum toxin type A ( BTX A; Xeomin ® ) temporarily blocks neuromuscular synapses. It is successfully and safely used therapeutically in various types of movement disorders and in chronic migraineurs. The mechanism of action of this treatment is related to a reduction of neurotransmitter release leading to reduced muscle activity. The following Null hypothesis will be tested: Injections of Xeomin® into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle) have no effect on bruxism measured by A) Masticatory muscle activity (1° objective) B) Subjects' well-being (2° objective) C) Sensitivity of masticatory muscles and jaw joints (2° objective) D) Anxiety over tooth wear (2° objective) E) Disturbed sleep by bed partner (2° objective) Following instruments will be used: 1. WISE questionnaires. A comprehensive web-based interdisciplinary symptom evaluation tool. 2. Algometer for sensitivity measure of masticatory muscles and jaw joints. 3. Bio-signal recorder. Parallel to the Electromyography (EMG) of the masseter muscles, other bio-signals such as a number of electroencephalographic (EEG) derivations, electrooculogram (EOG ) as well as an electrocardiogram (ECG) will be recorded, in order to detect sleep stages and better identify bruxism episodes. The device used in this study has been approved for projects NIH #2R01DE016417-05A1 and #1 R01DE028548-01. 4. Ultrasound for masseter muscle thickness measure 5. Dual-color chewing gum for chewing efficiency measure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04792398
Study type Interventional
Source University of Zurich
Contact Dominik A Ettlin, MD, DMD
Phone +41 44 6343254
Email dominik.ettlin@zzm.uzh.ch
Status Not yet recruiting
Phase Phase 4
Start date May 1, 2021
Completion date June 2023

See also
  Status Clinical Trial Phase
Completed NCT04015349 - Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults.
Completed NCT03825237 - Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism
Completed NCT04934449 - Occlusal Splints in the Treatment of Sleep Bruxism N/A