Clinical trial NCT06894472: A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients
Official title: A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bruxism
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Masseter Hyperactivity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for Science and Technology
Study officials:
affiliation: Lecturer
name: Sara Abdullah mohamed elsamahy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Mohamed Farouk Abdel-Latif, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Amal Ahmed Mohamed Morsi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Wafaa Atef Abd Allah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ass. Lecturer
name: Myassar Ayman Amine, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: