Bruxism Xeomin® Intervention Trial
BRUX-XIT
Effects of Botulinum Toxin Type A (Xeomin®) Injections Into Bilateral Masseter Muscles for Management of Bruxism and Associated Symptoms: Single Center Open Label Longitudinal Pilot Study
1 other identifier
interventional
6
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2021
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 11, 2021
March 1, 2021
1.7 years
March 2, 2021
March 9, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change of maximum EMG amplitudes
Change of average of maximum EMG amplitudes of all bruxism events per night between days 1-14 (baseline) and days 29-42.
days 1-14, days 29-42
Verbal Rating Scale of Global impression of change
Verbal Rating Scale (VRS) containing the following levels "much worse", "slightly worse", "no change", "slightly improved", "much improved" of "global impression of change" at the end of the study (day 154)
day 154
Secondary Outcomes (13)
Change of maximum EMG amplitude
days 1-14, days 15-28, days 85-98, days 141-154
EMG amplitude at maximum voluntary contraction
days 1-14, days 15-28, days 85-98, days 141-154
number of masseter contraction episodes per hour (N/h)
days 1-14, days 15-28, days 85-98, days 141-154
duration of masseter contraction episodes (Dur)
days 1-14, days 15-28, days 85-98, days 141-154
EMG-Index
days 1-14, days 15-28, days 85-98, days 141-154
- +8 more secondary outcomes
Study Arms (1)
Sleep Bruxism Subjects
EXPERIMENTALUltrasound 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.
Interventions
Injections into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dominik Ettlinlead
- Merz Pharmaceuticalscollaborator
Study Sites (1)
University of Zurich, Center of Dental Medicine
Zurich, 8032, Switzerland
Related Publications (3)
Ettlin DA, Sommer I, Bronnimann B, Maffioletti S, Scheidt J, Hou MY, Lukic N, Steiger B. Design, construction, and technical implementation of a web-based interdisciplinary symptom evaluation (WISE) - a heuristic proposal for orofacial pain and temporomandibular disorders. J Headache Pain. 2016 Dec;17(1):77. doi: 10.1186/s10194-016-0670-5. Epub 2016 Aug 31.
PMID: 27581159BACKGROUNDIwasaki LR, Gonzalez YM, Liu H, Marx DB, Gallo LM, Nickel JC. A pilot study of ambulatory masticatory muscle activities in temporomandibular joint disorders diagnostic groups. Orthod Craniofac Res. 2015 Apr;18 Suppl 1(0 1):146-55. doi: 10.1111/ocr.12085.
PMID: 25865543BACKGROUNDSilva LC, Nogueira TE, Rios LF, Schimmel M, Leles CR. Reliability of a two-colour chewing gum test to assess masticatory performance in complete denture wearers. J Oral Rehabil. 2018 Apr;45(4):301-307. doi: 10.1111/joor.12609. Epub 2018 Feb 9.
PMID: 29356092BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominik A Ettlin, MD, DMD
University of Zurich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Study Principal Investigator, MD, DMD
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 11, 2021
Study Start
May 1, 2021
Primary Completion
December 31, 2022
Study Completion
June 1, 2023
Last Updated
March 11, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share