Occlusal splint and masseter Botox effects on jaw and neck muscles
Official title: Evaluation of the Effects of Occlusal Splint and Masseter Botulinum Toxin Injections on Head and Neck Muscles Using Electromyography
Run by Istanbul University · NCT07082972 · Data updated 2026-11-12
We will test whether a custom jaw splint, Botox injections into the masseter muscles, or both, can change head and neck muscle activity in adults with myofascial pain syndrome.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Vezneciler) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT07082972 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with myofascial pain syndrome who have normal BMI, no missing teeth, no prior TMD treatment, and who can attend visits at Istanbul University are ideal candidates.
✕Probably not a fit
People who are pregnant or lactating, have missing teeth, BMI outside the normal range, systemic neuromuscular or bleeding disorders, recent facial aesthetic procedures, or prior masseter Botox are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, parallel-group trial that will enroll 56 adults with myofascial pain syndrome and normal BMI and full dentition, randomly assigning them to one of four groups: masseter Botox only, occlusal splint only, combined Botox and splint, or no treatment. Botox (20 IU per masseter, delivered at three sites per side) will be given by a neurologist and splints will be custom-made from hard vinyl acetate for the upper jaw. Surface electromyography (EMG) of masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles will be recorded at baseline, 4 weeks, and 12 weeks to measure changes in muscle activity. All procedures and follow-up EMG recordings will take place at Istanbul University in Istanbul.
Why it matters
Potential benefit: If successful, the treatments could reduce abnormal head and neck muscle activity and help guide better non‑surgical management of myofascial pain syndrome.
How similar studies have gone: Previous studies of masseter Botox and of occlusal splints for TMD-related muscle pain have shown mixed but sometimes promising results, so combining them in a randomized design addresses an open question.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Istanbul University
Istanbul, Vezneciler, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Afra Avar, DDS
- Email: afraavar@gmail.com
- Phone: +905398757502
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.