Surface Electromyography in the Detection and Assessment of Bruxism

Official title

Efficacy of Manual Therapy in Indirect Non-Invasive Neuromodulation of the Vagus Nerve in the Treatment of Bruxism in Young Adult Population up to 40 Years Old

Overview

Introduction: Sleep bruxism is defined as the repetitive activity of the masticatory muscles, characterized by clenching or grinding of the teeth. Studies confirm the association between sleep bruxism and episodes of masticatory muscle activity, with an increase in autonomic sympathetic activity observed during transient periods of sleep. This is associated with nocturnal awakenings, related to increased cardiac, cerebral (cortical arousal), respiratory, and muscular activity. Objectives: The main objectives are "To study the mean power frequency (MPF) of the masticatory muscles measured by surface electromyography (sEMG) in the general population (with and without bruxism according to ICSD-3 and DC/TMD criteria)"; and "to assess the effectiveness of manual therapy applied to structures adjacent to the vagus nerve based on its impact on orofacial pain and symptomatology in patients with bruxism". Material and Methods: A cross-sectional observational study and a randomized controlled experimental study were designed. The first will analyze data collected by sEMG in the masticatory muscles, at rest and during maximum clenching, comparing results between bruxists and non-bruxists. The second will analyze, compared to the control group, data collected on signs (range of motion alteration, presence of sounds), symptomatology (pain, headaches, sensation of blockage, functional limitation) caused by bruxism, sleep quality (Pittsburgh Sleep Quality Index (PSQI)), oral health-related quality of life (OHIP-14), stress and anxiety status (Perceived Stress Scale and GAD-7 (Generalized Anxiety Disorder-7), respectively), and sympathetic-vagal balance (Heart Rate Variability in its frequency and time domains) before and after a manual therapy intervention on structures adjacent to the vagus nerve pathway (head, neck, thorax, diaphragm, abdomen). The collected data will be analyzed using IBM SPSS® version 25.0.0.

Interventions

• Diagnostic test sEMG
  The spectral characteristics in the amplitude domain will be recorded through the root mean square (RMS, unit: μV) or the mean power frequency (MPF, unit: Hz) of the musculature to be evaluated by means of EMGs, with the electrodes placed parallel to the muscle fibers of the temporal, masseter, and suprahyoid muscles. Standardized EMGs will be recorded and compared in resting position and during maximum voluntary clenching

Primary outcome measures

• Motor recruitment pattern of the masseter, temporalis, and suprahyoid muscles [Time frame: 1 day, baseline]

Secondary outcome measures (12)

• Orofacial Pain (1) [Time frame: 1 day, baseline]
• Orofacial Pain (2) [Time frame: 1 day, baseline]
• Orofacial Pain (3) [Time frame: 1 day, baseline]
• Range of Motion (1) [Time frame: 1 day, baseline]
• Range of Motion (2) [Time frame: 1 day, baseline]
• Jaw Funcionality [Time frame: 1 day, baseline]
• Oral behavior [Time frame: 1 day, baseline]
• Headaches [Time frame: 1 day, baseline]
• Sleep Quality [Time frame: 1 day, baseline]
• Oral health-related quality of life [Time frame: 1 day, baseline]
• Stress [Time frame: 1 day, baseline]
• Anxiety [Time frame: 1 day, baseline]

Eligibility criteria

Inclusion criteria

For patients with bruxism:

• Sleep bruxism diagnosed according to the ICSD-III (International Classification of Sleep Disorders, 3rd edition):

• Regular or frequent tooth grinding sounds occurring during sleep and the presence of one or more of the following clinical signs and symptoms:

• Abnormal tooth wear consistent with reports of clenching/grinding the teeth during sleep
• Transient morning pain or fatigue in the jaw muscles; and/or temporal headaches; and/or jaw locking upon awakening, consistent with reports of clenching/grinding the teeth during sleep
• Sleep bruxism diagnosed according to the RDC/TMD:

• Interview: During the interview, subjects are asked about the following symptoms: reports of regular or frequent tooth grinding during sleep, muscle fatigue, temporal headache, transient morning muscle pain in the jaw, and jaw locking upon awakening.
• Physical examination: Presence or signs suggesting abnormal dental wear, such as teeth with flattened cusps and/or loss of contour with dentin exposure.

• Hypertrophy of the masticatory muscles
• Dental impressions on the tongue
• Linea alba on the cheeks along the bite line
• Damage to dental tissue
• Excessive dental wear
• A minimum pain intensity score of 3 on the Visual Analogue Scale at the masseter and temporal algometry points.
• EMGs with elevated mean power frequency for the masseter and temporalis muscles (to be defined in the first clinical phase-observational study).
• Age between 18 and 40 years.

For patiens without bruxism:

a)Asymptomatic and without signs of bruxism or other craniofacial pathologies.

Exclusion criteria

• Having suffered direct trauma, mandibular fractures, or surgeries in the orofacial region.
• Loss of more than 2 teeth, except for the third molar.
• Use of muscle relaxant medication or medications that may influence motor behavior.
• Having received botulinum toxin treatment in the last 6 months.
• Periodontal disorders or current orthodontic treatment or prosthesis.
• Partial or total dentures.
• History of medical disorders (severe psychiatric, physiological, or neurological conditions).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Spain · 1 center

• Universitat International de Catalunya (UIC) — Sant Cugat del Vallès

Publications

• Abe S, Huynh NT, Kato T, Rompre PH, Landry-Schonbeck A, Landry ML, de Grandmont P, Kawano F, Lavigne GJ. Oral appliances reduce masticatory muscle activity-sleep bruxism metrics independently of changes in heart rate variability. Clin Oral Investig. 2022 Sep;26(9):5653-5662. doi: 10.1007/s00784-022-04520-y. Epub 2022 May 10. PMID 35538329
• Matusz K, Maciejewska-Szaniec Z, Gredes T, Pobudek-Radzikowska M, Glapinski M, Gorna N, Przystanska A. Common therapeutic approaches in sleep and awake bruxism - an overview. Neurol Neurochir Pol. 2022;56(6):455-463. doi: 10.5603/PJNNS.a2022.0073. Epub 2022 Nov 29. PMID 36444852
• Amorim CSM, Espirito Santo AS, Sommer M, Marques AP. Effect of Physical Therapy in Bruxism Treatment: A Systematic Review. J Manipulative Physiol Ther. 2018 Jun;41(5):389-404. doi: 10.1016/j.jmpt.2017.10.014. PMID 30041736
• Kuang B, Li D, Lobbezoo F, de Vries R, Hilgevoord A, de Vries N, Huynh N, Lavigne G, Aarab G. Associations between sleep bruxism and other sleep-related disorders in adults: a systematic review. Sleep Med. 2022 Jan;89:31-47. doi: 10.1016/j.sleep.2021.11.008. Epub 2021 Nov 19. PMID 34879286
• Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21. PMID 29926505
• Thymi M, Shimada A, Lobbezoo F, Svensson P. Clinical jaw-muscle symptoms in a group of probable sleep bruxers. J Dent. 2019 Jun;85:81-87. doi: 10.1016/j.jdent.2019.05.016. Epub 2019 May 11. PMID 31085350
• Michalek-Zrabkowska M, Martynowicz H, Wieckiewicz M, Smardz J, Poreba R, Mazur G. Cardiovascular Implications of Sleep Bruxism-A Systematic Review with Narrative Summary and Future Perspectives. J Clin Med. 2021 May 21;10(11):2245. doi: 10.3390/jcm10112245. PMID 34064229
• Schaffarczyk M, Rogers B, Reer R, Gronwald T. Validity of the Polar H10 Sensor for Heart Rate Variability Analysis during Resting State and Incremental Exercise in Recreational Men and Women. Sensors (Basel). 2022 Aug 30;22(17):6536. doi: 10.3390/s22176536. PMID 36081005

Identifiers

NCT: NCT07070947 · EMGBruxism

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗