Status:

UNKNOWN

Bruxism Xeomin® Intervention Trial

Lead Sponsor:

Dominik Ettlin

Collaborating Sponsors:

Merz Pharmaceuticals

Conditions:

Sleep Bruxism, Adult

Eligibility:

All Genders

18-90 years

Phase:

PHASE4

Brief 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 appli...

Detailed 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 musc...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2023

Estimated Enrollment :

6 Patients enrolled

Trial Details

Trial ID

NCT04792398

Start Date

May 1 2021

End Date

June 1 2023

Last Update

March 11 2021

Active Locations (1)

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1

University of Zurich, Center of Dental Medicine

Zurich, Switzerland, 8032