NCT07082972 EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
| NCT ID | NCT07082972 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Istanbul University |
| Condition | Myofascial Pain Syndrome (MPS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 56 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Olcay Şakar, Phd Prof.
STUDY DIRECTOR
Istanbul University
Frequently Asked Questions
Who can join the NCT07082972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Myofascial Pain Syndrome (MPS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07082972 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07082972 currently recruiting?
Yes, NCT07082972 is actively recruiting participants. Contact the research team at afraavar@gmail.com for enrollment information.
Where is the NCT07082972 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07082972 clinical trial?
NCT07082972 is sponsored by Istanbul University. The principal investigator is Olcay Şakar, Phd Prof. at Istanbul University. The trial plans to enroll 56 participants.