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A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients

A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06894472
Enrollment
30
Registered
2025-03-25
Start date
2025-03-26
Completion date
2025-05-01
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism

Brief summary

This study examines the effect of electromyography biofeedback on masticatory muscles hyperactivity on patients with bruxism.

Detailed description

Bruxism is a movement disorder characterized by excessive activity of the masticatory muscles, resulting in teeth clenching and grinding. It affects 50% to 95% of the adult population. Unlike normal, voluntary chewing movements associated with eating, bruxism involves involuntary jaw muscle contractions that cause tension, leading to muscle soreness and pain. Common symptoms include localized muscle tenderness, orofacial pain, anxiety, stress, fatigue, headaches (especially in the temporal region), restricted mouth opening, and temporomandibular joint stiffness. These symptoms can disrupt sleep, causing transitions from deep to light sleep, increased micro-arousals, and sleep fragmentation, leading to daytime fatigue that impacts social life and work performance. Bruxism can also lead to masticatory muscle hypertrophy (especially the masseter), tongue burning, linea alba on the cheeks, excessive tooth wear, damage to dental prosthetics, changes in saliva secretion, severe craniofacial pain, and TMJ stiffness. Common treatments for bruxism-related pain often involve medications like Botox, clonazepam, or diazepam, but these are typically temporary and do not address the underlying causes. Moreover, long-term use of these medications may cause complications, and their high cost can limit accessibility. Non-pharmacological treatments for bruxism include biofeedback, muscle relaxation exercises, occlusal splint therapy, and psychotherapy. Biofeedback, which provides real-time information on bodily functions, helps individuals recognize and modify harmful behaviors. Electromyography (EMG) biofeedback, recognized as effective for temporomandibular disorders (including bruxism), is endorsed by the American Association of Psychophysiology and Biofeedback (AAPB) as an evidence-based intervention. This study aims to compare the effects of EMG biofeedback training versus oral medications in reducing masticatory muscle hyperactivity in bruxism patients, focusing on addressing the underlying pathophysiology, a topic that, to the authors' knowledge, has not been explored in previous research.

Interventions

Participants in the experimental group will receive surface electromyography (SEMG) feedback training, targeting the Masseter muscle, for 40 minutes per session according to the Evidence-Based practice since longer practice may become counterproductive due to fatigue and loss of focus. The frequency of the sessions will be 3 sessions/week for 4 weeks.

Pharmacotherapy will be received by all participants in the two groups in the form of multi relaxant (cyclobenzaprine) 10 MG twice daily for 4 weeks & anti inflammatory (non steroidal anti-inflammatory drugs).

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Twenty adult subjects with definite mild to moderate bruxism examined by a dentist prior to the study. * Tenderness of masticatory muscles on palpation grade one and two according to the digital palpating scale * Mild to moderate myofascial pain around the temporomandibular joint causing discomfort in the morning.

Exclusion criteria

* Took any Botox or PRP injection treatment for this condition for the last six months * Had any advanced periodontal disease. * Any intraoral fixed splints. * Pregnancy. * Under psychiatric care. * Parkinson * Have any visual or auditory impairment. * Any cervical posture abnormalities.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Masseter Hyperactivity4 weeksThe assessment of Masseter muscle hyperactivity will be carried out by the digital palpating scale according to the following criteria: Grade Zero (0): when the muscle palpated and there is no pain or tenderness reported by the patient. Grade (1): Recorded if the patient response the palpation is uncomfortable (tenderness or soreness). Grade (2): is recorded if the patient experiences definite discomfort or pain. Grade (3): is recorded if the patient shows evasive action or eye tearing or verbalizes a desire not to have the area palpated again.

Countries

Egypt

Contacts

Primary ContactSara Abdullah mohamed elsamahy, PhD
Saraaelsamahy@gmail.com+20 11 51401438

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026