UnknownPhase 4

Bruxism Xeomin® Intervention Trial

Switzerland6 participantsStarted 2021-05-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change of maximum EMG amplitudes

Timeframe: days 1-14, days 29-42

Verbal Rating Scale of Global impression of change

Timeframe: day 154

Trial details

NCT IDNCT04792398

SponsorDominik Ettlin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Contact for this trial

Dominik A Ettlin, MD, DMD

+41 44 6343254 dominik.ettlin@zzm.uzh.ch

View on ClinicalTrials.gov More Sleep Bruxism, Adult trials