Actively Recruiting
EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
Led by Istanbul University · Updated on 2025-07-24
56
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myofascial pain syndrome
- No missing teeth
- No history of previous temporomandibular disorder treatment
- No presence of arthrogenic temporomandibular disorder
You will not qualify if you...
- Pregnancy or lactation
- Osteoporosis or bisphosphonate use
- Previous botulinum toxin injection to the masseter region
- Bleeding disorders or use of anticoagulant medications
- Presence of systemic muscular or neurological diseases such as myasthenia gravis or ALS
- Active infection, open wound, or skin condition in the facial area
- Facial aesthetic procedures within the last six months
- Severe psychiatric disorders or regular use of psychiatric medications
- Unlikely to comply with study protocol or complete follow-up
- Body mass index outside the normal range, including underweight or overweight
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istanbul University
Istanbul, Vezneciler, Turkey (Türkiye), 34116
Actively Recruiting
Research Team
A
Afra Avar, DDS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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