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| Name | Class |
|---|---|
| Merz Pharmaceuticals | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Bruxism Subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incobotulinumtoxin A (BTX A) Xeomin® | Drug | Injections into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | days 1-14, days 15-28, days 85-98, days 141-154 |
| EMG amplitude at maximum voluntary contraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominik A Ettlin, MD, DMD | Contact | +41 44 6343254 | dominik.ettlin@zzm.uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Dominik A Ettlin, MD, DMD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich, Center of Dental Medicine | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27581159 | Background | 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. | |
| 25865543 |
| Label | URL |
|---|---|
| Homepage Company used Medical Device Algomed | View source |
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| ID | Term |
|---|---|
| D020186 | Sleep Bruxism |
| ID | Term |
|---|---|
| D002012 | Bruxism |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020447 | Parasomnias |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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Observational study
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EMG signal amplitude (RMS) at maximum voluntary contraction (MVC) in [V] |
| days 1-14, days 15-28, days 85-98, days 141-154 |
| 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] | days 1-14, days 15-28, days 85-98, days 141-154 |
| duration of masseter contraction episodes (Dur) | duration of masseter contraction episodes in [sec] calculated from EMG signal amplitude normalized on MVC | days 1-14, days 15-28, days 85-98, days 141-154 |
| EMG-Index | EMG-Index = 0.5 x N/h + Dur | days 1-14, days 15-28, days 85-98, days 141-154 |
| EMG Duty Factor | EMG duty factor = % duration of muscle activity/total recording time | days 1-14, days 15-28, days 85-98, days 141-154 |
| Sensitivity of masticatory muscles and jaw joints | Sensitivity of masticatory muscles and jaw joints in [N] | day 1, 14, 28, 42, 98, 154 |
| Self-report of bruxism | Yes/No answer to direct question | day 1, 14, 28, 42, 98, 154 |
| Numerical Rating Scale masseter muscle pain | Numerical Rating Scale (NRS) (0-10) with 0 = no pain and 10 = worst imaginable pain | day 1, 14, 28, 42, 98, 154 |
| Numerical Rating Scale report of spontaneous facial pain | Numerical Rating Scale (NRS) (0-10) with 0 = no pain and 10 = worst imaginable pain | day 1, 14, 28, 42, 98, 154 |
| 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 | day 1, 14, 28, 42, 98, 154 |
| Numerical Rating Scale report of anxiety over tooth wear | Numerical Rating Scale (NRS) (0-10) with 0 = no anxiety and 10 = worst imaginable anxiety | day 1, 14, 28, 42, 98, 154 |
| Numerical Rating Scale disturbed sleep of bed partner | Numerical Rating Scale (NRS) (0-10) with 0 = no disturbed sleep and 10 = worst imaginable sleep | day 1, 14, 28, 42, 98, 154 |
| 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. |
| 29356092 | Background | 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. |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |