Overview

Bruxism Xeomin® Intervention Trial

Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dominik Ettlin
Collaborator:
Merz Pharmaceuticals
Treatments:
incobotulinumtoxinA
Criteria
Inclusion Criteria:

- Age 18-90 years;

- patients complaining of bruxism and/or bruxism-related symptoms.

- Sufficient knowledge of German to understand the patient information and the trial
arrangement.

Exclusion Criteria:

- Contraindications for Xeomin® treatment such as generalized disorders of muscle
activity (myasthenia gravis, Lambert-Eaton-Rooke syndrome);

- documented hypersensitivity to one of the components,

- local infection of the injection sites;

- intake of anticoagulants or muscle relaxing medications;

- recreational drugs.