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

Not Applicable

Not yet recruiting

• Conditions: Bruxism
• Interventions: Other: Electromyography biofeedback; Drug: Pharmacotherapy

• Registration Number: NCT06894472
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-03-26
• Primary Completion: 2025-04-26
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electromyography biofeedback + Pharmacotherapy	Electromyography biofeedback	This group will be treated with electromyography biofeedback for one month with a frequency of 3 sessions/week in addition to the pharmacotherapy which prescribed by the dentist.
Electromyography biofeedback + Pharmacotherapy	Pharmacotherapy	This group will be treated with electromyography biofeedback for one month with a frequency of 3 sessions/week in addition to the pharmacotherapy which prescribed by the dentist.
Pharmacotherapy	Pharmacotherapy	This group will be treated only with the pharmacotherapy which prescribed by the dentist.

Primary Outcome Measures

Name	Time	Method
Assessment of Masseter Hyperactivity	4 weeks	The 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.

Trial Locations

Locations (1)

Misr University for Science and Technology; 🇪🇬 Giza, Egypt