Bruxism Xeomin® Intervention Trial

NCT ID: NCT04792398

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-06-30

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.

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.

Conditions

Sleep Bruxism, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Incobotulinumtoxin A (BTX A) Xeomin®

Intervention Type: DRUG

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

Interventions

Incobotulinumtoxin A (BTX A) Xeomin®

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Dominik Ettlin

OTHER

Sponsor Role: lead

Responsible Party

Dominik Ettlin

Study Principal Investigator, MD, DMD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominik A Ettlin, MD, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University of Zurich, Center of Dental Medicine

Zurich, , Switzerland

Countries

Switzerland

Central Contacts

Dominik A Ettlin, MD, DMD

Role: CONTACT

dominik.ettlin@zzm.uzh.ch

+41 44 6343254

References

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.

Reference Type: BACKGROUND

PMID: 27581159 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25865543 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29356092 (View on PubMed)

Related Links

http://www.cephalon.eu/products/sensory/algomed/

Homepage Company used Medical Device Algomed

Other Identifiers

BRUX-XIT

Identifier Type: -

Identifier Source: org_study_id