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Sleep Bruxism, AdultPhase 4BRUX-XITNCT04792398

Bruxism Xeomin® Intervention Trial

A Phase 4 study testing Incobotulinumtoxin A (BTX A) Xeomin® in people with Sleep Bruxism, Adult, run by Dominik Ettlin at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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®). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Sleep Bruxism, Adult
What is being tested?
Incobotulinumtoxin A (BTX A) Xeomin®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSwitzerland
Study dates
1 May 2021to Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Dominik A Ettlin, MD, DMD contact

+41 44 6343254

dominik.ettlin@zzm.uzh.ch

Switzerland1 site

  • University of Zurich, Center of Dental Medicine

    Zurich, 8032

Other trials in Switzerland

About this study

Official title: 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

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.

Read the 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 muscles for the management of sleep bruxism and associated symptoms. The hypothesis is that BTX-A reduces masticatory muscle activity. The aim of this study is to instrumentally monitor subjects closely over an extended time period of three months before and after application of BTX-A.

Botulinum toxin type A ( BTX A; Xeomin ® ) temporarily blocks neuromuscular synapses. It is successfully and safely used therapeutically in various types of movement disorders and in chronic migraineurs. The mechanism of action of this treatment is related to a reduction of neurotransmitter release leading to reduced muscle activity.

The following Null hypothesis will be tested:

Injections of Xeomin® into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle) have no effect on bruxism measured by A) Masticatory muscle activity (1° objective) B) Subjects' well-being (2° objective) C) Sensitivity of masticatory muscles and jaw joints (2° objective) D) Anxiety over tooth wear (2° objective) E) Disturbed sleep by bed partner (2° objective)

Following instruments will be used:

  1. WISE questionnaires. A comprehensive web-based interdisciplinary symptom evaluation tool.
  2. Algometer for sensitivity measure of masticatory muscles and jaw joints.
  3. Bio-signal recorder. Parallel to the Electromyography (EMG) of the masseter muscles, other bio-signals such as a number of electroencephalographic (EEG) derivations, electrooculogram (EOG ) as well as an electrocardiogram (ECG) will be recorded, in order to detect sleep stages and better identify bruxism episodes. The device used in this study has been approved for projects NIH #2R01DE016417-05A1 and #1 R01DE028548-01.
  4. Ultrasound for masseter muscle thickness measure
  5. Dual-color chewing gum for chewing efficiency measure.
Being tested
Incobotulinumtoxin A (BTX A) Xeomin®
Medical subject headings
Sleep Bruxism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incobotulinumtoxin A (BTX A) Xeomin®Drug

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

Study groups in NCT04792398
Study groupRoleWhat they receive
Sleep Bruxism SubjectsExperimentalUltrasound 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.
Receives: Drug: Incobotulinumtoxin A (BTX A) Xeomin®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: days 1-14, days 29-42

  2. 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)

    Measured: day 154

Secondary outcomes (13)

  1. Change of maximum EMG amplitude

    Change of average of maximum EMG amplitudes of all bruxism events per night between days 1-14 (baseline) and days 15-28, 85-98, and 141-154.

    Measured: days 1-14, days 15-28, days 85-98, days 141-154

  2. EMG amplitude at maximum voluntary contraction

    EMG signal amplitude (RMS) at maximum voluntary contraction (MVC) in [V]

    Measured: days 1-14, days 15-28, days 85-98, days 141-154

  3. number of masseter contraction episodes per hour (N/h)

    number of masseter contraction episodes per hour calculated from EMG signal amplitude normalized on MVC [N/h]

    Measured: days 1-14, days 15-28, days 85-98, days 141-154

  4. duration of masseter contraction episodes (Dur)

    duration of masseter contraction episodes in [sec] calculated from EMG signal amplitude normalized on MVC

    Measured: days 1-14, days 15-28, days 85-98, days 141-154

  5. EMG-Index

    EMG-Index = 0.5 x N/h + Dur

    Measured: days 1-14, days 15-28, days 85-98, days 141-154

  6. EMG Duty Factor

    EMG duty factor = % duration of muscle activity/total recording time

    Measured: days 1-14, days 15-28, days 85-98, days 141-154

  7. Sensitivity of masticatory muscles and jaw joints

    Sensitivity of masticatory muscles and jaw joints in [N]

    Measured: day 1, 14, 28, 42, 98, 154

  8. Self-report of bruxism

    Yes/No answer to direct question

    Measured: day 1, 14, 28, 42, 98, 154

  9. Numerical Rating Scale masseter muscle pain

    Numerical Rating Scale (NRS) (0-10) with 0 = no pain and 10 = worst imaginable pain

    Measured: day 1, 14, 28, 42, 98, 154

  10. Numerical Rating Scale report of spontaneous facial pain

    Numerical Rating Scale (NRS) (0-10) with 0 = no pain and 10 = worst imaginable pain

    Measured: day 1, 14, 28, 42, 98, 154

  11. Numerical Rating Scale report of jaw movement related facial pain

    Numerical Rating Scale (NRS) (0- 10) with 0 = no pain and 10 = worst imaginable pain

    Measured: day 1, 14, 28, 42, 98, 154

  12. Numerical Rating Scale report of anxiety over tooth wear

    Numerical Rating Scale (NRS) (0-10) with 0 = no anxiety and 10 = worst imaginable anxiety

    Measured: day 1, 14, 28, 42, 98, 154

  13. Numerical Rating Scale disturbed sleep of bed partner

    Numerical Rating Scale (NRS) (0-10) with 0 = no disturbed sleep and 10 = worst imaginable sleep

    Measured: day 1, 14, 28, 42, 98, 154

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start1 May 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Observational study
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792398
Sponsor's protocol ID
BRUX-XIT
Acronym
BRUX-XIT
Status last verified
Mar 2021
First submitted
2 Mar 2021
Last updated
11 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27581159

  • Iwasaki 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.

    PubMed 25865543

  • Silva 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.

    PubMed 29356092

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Incobotulinumtoxin A (BTX A) Xeomin® in people with Sleep Bruxism, Adult, run by Dominik Ettlin at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dominik A Ettlin, MD, DMD (+41 44 6343254, dominik.ettlin@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of maximum EMG amplitudes (time frame: days 1-14, days 29-42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792398, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.

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