Using an occlusal (bite) splint for jaw and neck muscle pain from bruxism
Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain: An Ultrasonographic Study
This project will try an occlusal (bite) splint for adults with bruxism and jaw muscle pain to see if symptoms and ultrasound findings improve over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07090551 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling patients from the Temporomandibular Disorders Clinic at Istanbul University Faculty of Dentistry who were suspected of masticatory muscle–origin TMD and referred for ultrasonography. Participants who have already started routine occlusal splint therapy after definitive clinical and imaging diagnosis will be followed for a 12-week treatment period without altering their care. Baseline TMD-DC symptom forms and ultrasound images will be compared with repeat forms and a second ultrasound at the end of 12 weeks to document symptom and muscle changes. The project focuses on adults with myofascial pain or local myalgia related to bruxism and uses standard clinical measures and imaging to track outcomes.
Who should consider this trial
Good fit: Adults (age 18+) with bruxism and diagnosed masticatory muscle pain or myofascial pain who have not received prior TMD treatment are ideal candidates.
Not a fit: Patients whose TMD stems from joint disorders (e.g., disc displacement or arthropathy), those under 18, or those with prior TMD treatment are unlikely to benefit from inclusion in this protocol.
Why it matters
Potential benefit: If successful, occlusal splint therapy could reduce jaw pain and muscle tension and show matching improvements on ultrasound, supporting its use as a noninvasive treatment option.
How similar studies have performed: Occlusal splints are widely used and have shown symptomatic benefit in some prior studies, but evidence for consistent objective muscle changes on imaging is mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients who have presented to the Faculty of Dentistry at Istanbul University with temporomandibular disorder (TMD) complaints, Patients diagnosed with myospasm and/or myofascial pain syndrome in the masseter and/or temporalis muscles prior to treatment, Patients with no physical or mental disabilities, Patients over the age of 18, Patients who have not previously received any treatment for TMD. Exclusion Criteria: Patients with any type of TMD other than masticatory muscle disorders, Patients who have previously received any form of TMD treatment, Patients under the age of 18.
Where this trial is running
Istanbul
- Istanbul University Faculty of Dentistry — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: berk bilgen, phd — Istanbul University
- Study coordinator: enes akpınar, des
- Email: enesakpinar@istanbul.edu.tr
- Phone: 0090 5395847509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.