Evaluation of the Effects of Occlusal Splint and Masseter Botulinum Toxin Injections on Head and Neck Muscles Using Electromyography

Status: Recruiting
Location: See location...
Intervention Type: Drug, Combination product, Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). MPS is a common subtype of temporomandibular disorders (TMD), frequently involving the masticatory and cervical muscles. Despite various treatment modalities, there is still no universally accepted protocol. In this study, 56 adult participants of both sexes, without missing teeth and within a normal body mass index (BMI) range, will be randomly assigned to four groups: BTX-A injection only, occlusal splint only, combined BTX-A and splint therapy, and an untreated control group. Surface electromyography (EMG) will be used to assess muscle activity in the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. EMG recordings will be performed at baseline, 4 weeks, and 12 weeks after the intervention. Pain levels and symptom severity will be assessed using the DC/TMD symptom questionnaire and the Visual Analog Scale (VAS). BTX-A injections will be administered by a neurology specialist (20 IU per masseter muscle), and occlusal splints will be custom-fabricated and fitted for each participant. This study seeks to determine the neuromuscular effects of these treatments-both alone and in combination-on masticatory and cervical muscles and to provide insight into the development of more comprehensive and effective treatment strategies for MPS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Having a diagnosis of myofascial pain syndrome

• No missing teeth

• No history of previous temporomandibular disorder treatment

• Absence of an arthrogenic temporomandibular disorder

Locations
Other Locations
Turkey
Istanbul University
RECRUITING
Istanbul
Contact Information
Primary
Afra Avar, DDS
afraavar@gmail.com
+905398757502
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 56
Treatments
Experimental: Botulinum toxin injection group
Patients will receive a total of 20 units of botulinum toxin injected into the masseter muscle on each side. EMG measurements will be taken before and after treatment to evaluate changes in muscle activity.
Experimental: Occlusal splint group
Patients will use occlusal splints during sleep. EMG recordings will assess the effect of splint therapy on muscle activity.
Experimental: Botulinum toxin + Occlusal splint combined group
Patients will receive 20 units of botulinum toxin injections into the masseter muscle on each side and use occlusal splints during sleep. EMG will monitor the combined effect on muscle activity.
No_intervention: Control group
Patients will not receive any active treatment. EMG measurements will observe natural changes over time.
Related Therapeutic Areas
Sponsors
Leads: Istanbul University

This content was sourced from clinicaltrials.gov