Sleep Bruxism, Adult Clinical Trial
— BRUX-XITOfficial 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.
Status | Not yet recruiting |
Enrollment | 6 |
Est. completion date | June 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Zurich, Center of Dental Medicine | Zurich |
Lead Sponsor | Collaborator |
---|---|
Dominik Ettlin | Merz Pharmaceuticals |
Switzerland,
Ettlin DA, Sommer I, Brönnimann 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. — View Citation
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 1:146-55. doi: 10.1111/ocr.12085. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | EMG amplitude at maximum voluntary contraction | EMG signal amplitude (RMS) at maximum voluntary contraction (MVC) in [V] | days 1-14, days 15-28, days 85-98, days 141-154 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | EMG-Index | EMG-Index = 0.5 x N/h + Dur | days 1-14, days 15-28, days 85-98, days 141-154 | |
Secondary | 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 | |
Secondary | Sensitivity of masticatory muscles and jaw joints | Sensitivity of masticatory muscles and jaw joints in [N] | day 1, 14, 28, 42, 98, 154 | |
Secondary | Self-report of bruxism | Yes/No answer to direct question | day 1, 14, 28, 42, 98, 154 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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