Electromyographic changes in masseter and sternocleidomastoid muscles can be applied to diagnose of temporomandibular disorders: An observational study.
Kwang-Ho Choi, O Sang Kwon, Lakhyung Kim...
https://pubmed.ncbi.nlm.nih.gov/34141576Actively Recruiting
Phase 4
Age: 18Years - 55Years
All Genders
ID07082972
Evaluation of the Effects of Occlusal Splint and Masseter Botulinum Toxin Injections on Head and Neck Muscles Using Electromyography
Led by Istanbul University · Updated on 2025-07-24
56
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections on the muscle activity of the head and neck in adults diagnosed with myofascial pain syndrome (MPS). This condition often involves pain in the jaw and neck muscles and is a common type of temporomandibular disorder. The study aims to understand how these treatments alone or combined affect muscle function and to help develop better treatment strategies for MPS. The study will include 56 adult participants who will be randomly assigned to one of four groups: BTX-A injections only, occlusal splint therapy only, combined BTX-A and splint therapy, or no treatment (control group). BTX-A will be injected into the masseter muscles at three standardized points on each side by a neurologist, while occlusal splints will be custom-made for participants to wear during sleep. Muscle activity will be recorded using surface electromyography (EMG) before treatment and at 4 and 12 weeks after treatment. Participants will complete questionnaires about their symptoms and pain levels at each visit. EMG will measure the activity of several muscles, including the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius. The study will monitor changes in muscle function and pain over 12 weeks. All procedures are supervised by professionals to ensure safety, and statistical analysis will compare the effects among the different groups to assess the treatments' impact on muscle activity and symptoms.
CONDITIONS
Brief Title
EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
Who Can Participate
Age: 18Years - 55Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of myofascial pain syndrome
- No missing teeth
- No history of previous temporomandibular disorder treatment
- Absence of arthrogenic temporomandibular disorder
- Adults aged 18 to 55 years
- Normal body mass index (BMI) range
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
- Systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS)
- Active infection, open wound, or skin condition on the face
- Facial aesthetic procedures within the last six months
- Severe psychiatric disorders or regular psychiatric medication use
- 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
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Initial treatment with follow-up assessments over 12 weeks
Participants receive either botulinum toxin injections into the masseter muscles, custom-made occlusal splints to wear during sleep, both treatments combined, or no treatment in the control group. EMG measurements are taken before treatment to evaluate muscle activity.
1 treatment visit (in-person) with EMG measurements at baseline, 4 weeks, and 12 weeks
Follow-up
Duration - 12 weeks post-treatment
Participants are monitored with repeat EMG measurements and pain assessments to evaluate the short- and long-term effects of the intervention or observation period.
2 follow-up visits (in-person) at 4 weeks and 12 weeks
Trial Site Locations
Total: 1 location
1
Istanbul University
Istanbul, Vezneciler, Turkey (Türkiye), 34116
Actively Recruiting
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Research Team
A
Afra Avar, DDS
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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Published Research Related To This Trial
Botulinum toxin treatment of temporomandibular joint pain in patients with bruxism: A prospective and randomized clinical study.
D I Kaya, H Ataoglu
https://pubmed.ncbi.nlm.nih.gov/33723117Which Treatment Is Effective for Bruxism: Occlusal Splints or Botulinum Toxin?
Mehmet Emre Yurttutan, Kevser Tütüncüler Sancak, Ayşegül Mine Tüzüner
https://pubmed.ncbi.nlm.nih.gov/31302066