EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles

Launched by ISTANBUL UNIVERSITY · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying ways to help people who have myofascial pain syndrome (MPS), a condition that causes muscle pain in the jaw and neck area. The study is looking at two treatments: special mouthpieces called occlusal splints, and injections of botulinum toxin (often known as Botox) into the jaw muscles. Researchers want to see how each treatment works alone and if combining them helps reduce muscle activity and pain better than either one by itself. They will use a test called electromyography (EMG) to measure muscle activity and also ask participants about their pain levels over a 12-week period.

Adults who have been diagnosed with MPS, have all their teeth, and have not had previous treatment for this jaw disorder may be eligible to join. Participants will be randomly placed into one of four groups: Botox injections only, occlusal splints only, both treatments together, or no treatment. Those in the Botox group will receive injections from a specialist, and those in the splint group will get a custom-made mouthpiece to wear. Throughout the study, muscle activity and pain will be checked at the start, after 4 weeks, and again at 12 weeks. The goal is to better understand how these treatments affect jaw and neck muscles and find improved ways to manage this type of muscle pain.

Gender

ALL

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.