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

Beni-Suef University

Status

Not yet enrolling

Conditions

Bruxism

Treatments

Drug: Pharmacotherapy

Other: Electromyography biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT06894472

FPTBSUREC/0805/2325

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

20 to 25 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Electromyography biofeedback + Pharmacotherapy

Experimental group

Description:

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.

Treatment:

Other: Electromyography biofeedback

Drug: Pharmacotherapy

Pharmacotherapy

Other group

Description:

This group will be treated only with the pharmacotherapy which prescribed by the dentist.

Treatment:

Drug: Pharmacotherapy