Bruxism Xeomin® Intervention Trial

Sponsor
Dominik Ettlin
Study ID
NCT04792398
Phase
PHASE4
Status
Unknown

Conditions

  • Sleep Bruxism, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2021
Status verified
Mar 2021
Primary completion
Dec 31, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sleep Bruxism Subjects
    Ultrasound guided BTX-A injection: 25 units (divided in two injections) in each masseter muscle. One-time intervention. Effect observation by measuring various biosignals (EMG, EOG, EEG), bite force, chewing efficiency, psychometric assessments.

Primary Outcome Measure

Change of maximum EMG amplitudes [ Time Frame: days 1-14, days 29-42 ]

Central Contacts