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Bruxism Xeomin® Intervention Trial

NCT04792398 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-03-11

No results posted yet for this study

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.

Conditions

  • Sleep Bruxism, Adult

Interventions

DRUG

Incobotulinumtoxin A (BTX A) Xeomin®

Injections into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle)

Sponsors & Collaborators

  • Merz Pharmaceuticals

    collaborator INDUSTRY

  • Dominik Ettlin

    lead OTHER

Principal Investigators

  • Dominik A Ettlin, MD, DMD · University of Zurich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04792398 on ClinicalTrials.gov