Ultrasonographic evaluation of the effect of splint therapy on masseter muscle and blood flow in patients with bruxism.
Eda Didem Yalcin, Elif Meltem Aslan Ozturk
https://pubmed.ncbi.nlm.nih.gov/35816105Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID07090551
Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain: An Ultrasonographic Study
Led by Istanbul University · Updated on 2026-05-05
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of occlusal splint therapy on head and neck muscles in patients with myofascial pain and bruxism related to temporomandibular disorders (TMD). The study focuses on patients who have previously visited a specialized clinic for TMD complaints and have been diagnosed with masticatory muscle disorders using clinical and radiographic evaluations, along with ultrasonographic imaging. The purpose is to evaluate changes in muscle thickness, elasticity, symptoms, and pain after treatment. Participants will be randomly assigned to one of two groups. The first group consists of patients undergoing routine occlusal splint therapy for 12 weeks, while the second group serves as a control and does not receive treatment during the study period. Both groups will have ultrasonographic imaging performed at the start and end of the 12-week period. The treatment group will follow their usual clinical care, and the control group will maintain their place in the treatment queue without intervention. During the study, participants will complete the Diagnostic Criteria for Temporomandibular Disorders (TMD-DC) form at baseline and after 12 weeks to assess symptom and pain changes. Ultrasonographic imaging will measure the thickness and elasticity of several head and neck muscles at both time points. The researchers will compare imaging and questionnaire results within and between groups to evaluate the impact of occlusal splint therapy on muscle morphology and function over the study period.
CONDITIONS
Brief Title
Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain
Who Can Participate
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants with myofascial pain receive occlusal splint therapy as part of routine clinical care for 12 weeks.
Visits occur during the 12-week treatment period as part of routine care
Long-term Monitoring
Duration - At 12 weeks after baseline
Participants in both the treatment and control groups complete follow-up assessments including ultrasonographic imaging and symptom questionnaires after 12 weeks to evaluate changes.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Istanbul University Faculty of Dentistry
Istanbul, Turkey (Türkiye)
Actively Recruiting
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Research Team
E
enes akpınar, des
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effects of occlusal splint therapy on the masseter and temporalis muscles in female patients with myofascial pain syndrome: An ultrasonographic study.
Berk Bilgen, Enes Akpınar, Rabia Duman Tepe...
https://pubmed.ncbi.nlm.nih.gov/40264294