EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles

PHASE4RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2026

Study Completion Date

December 1, 2026

Conditions
Myofascial Pain Syndrome (MPS)Masticatory Muscle Pain
Interventions
DRUG

Botulinum toxin injection

Patients will receive a total of 20 units of botulinum toxin type A (Botox) injected into each masseter muscle. The injections will be administered at three standardized sites on each side using a fine needle to ensure accurate delivery. Muscle activity will be recorded using electromyography (EMG) before the injection, and follow-up EMG measurements will be taken at one month and four months post-treatment to evaluate changes in muscle activity and treatment efficacy.

DEVICE

Occlusal splint

Patients with myofascial pain syndrome will receive custom-made occlusal splints to wear during sleep. These splints help reduce abnormal muscle activity and relieve pain by redistributing bite forces. EMG measurements will be taken before and during treatment to monitor changes in muscle activity.

COMBINATION_PRODUCT

Botulinum toxin + Occlusal splint combined

Patients will receive both botulinum toxin injections (20 units per masseter muscle, injected at three standardized points per side) and will use occlusal splints during sleep. EMG measurements will be conducted before treatment, and at follow-up visits to assess the combined effect of pharmacological and mechanical therapy on muscle activity.

Trial Locations (1)

34116

RECRUITING

Istanbul University, Istanbul

All Listed Sponsors
lead

Istanbul University

OTHER