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โ† Trials
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EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles

RecruitingPhase 4Ages 18 Years - 55 YearsAllIstanbul University
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In plain words

What the trial is, and whether it could suit you

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, spl

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Having a diagnosis of myofascial pain syndrome 2. No missing teeth 3. No history of previous temporomandibular disorder treatment 4. Absence of an arthrogenic temporomandibular disorder Exclusion Criteria: * Pregnancy or lactation; osteoporosis and bisphosphonate use * Previous botulinum toxin injection to the masseter region * Bleeding disorders or use of anticoagulant medications * Presence of systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS) * Active infection, open wound, or dermatological condition in the facial area * Undergoing other facial aesthetic procedures (e.g., fillers, PRP, etc.) within the last six months * Individuals with severe psychiatric disorders or those on regular psychiatric medications * Patients who are unlikely to comply with the study protocol or complete the follow-up period * Individuals with a body mass index (BMI) outside the normal range, including underweight or overweight participants, will be excluded from the study.
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What it tests

  • Botulinum toxin injection
  • Occlusal splint
  • Botulinum toxin + Occlusal splint combined
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Where

1 site
Istanbul University
Istanbul, Turkey (Tรผrkiye)
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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