An observational study in Myofascial Pain - Dysfunction Syndrome of TMJ, sponsored by Istanbul University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Istanbul University · Observational
"Female patients who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry, with complaints of muscle pain in the maxillofacial region and who are diagnosed with myofascial pain syndrome based on the results of their examination and the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form they completed, will be included in the study. Occlusal splint therapy will be initiated for these patients. Before starting occlusal splint therapy, ultrasound images will be taken from the patients. Subsequently, the patients will undergo routine occlusal splint therapy without any intervention in their 12-week treatment process. At the end of the 12-week treatment protocol, during the final control session, patients will fill the TMD-DC form again, and the two forms will be compared to evaluate changes in their clinical symptoms and pain. Additionally, a second ultrasound imaging will be taken during the same session. In this imaging, the thickness and blood flow of the masseter and temporal muscles will be examined, and comparisons will be made with the pre-treatment ultrasound. In this way, the effects of occlusal splints on muscle morphology and blood flow will be evaluated."
The study is designed as a prospective observational clinical study. Female patients will be selected from those who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry with various maxillofacial muscle pain complaints. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.)
During the examination of these patients, Temporomandibular Disorders Diagnostic Criteria (TMD-DC) forms will be completed to reach an accurate diagnosis. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study. Individuals participating in the study will be selected from this patient group. Before starting occlusal splint therapy, ultrasound (USG) images will be taken, focusing on the masseter muscle, temporal muscle, facial artery, maxillary artery, temporal artery, and external carotid artery.
The 12-week routine treatment of these patients will proceed without any intervention. At the end of their treatment, when patients return for their final control session, they will complete the TMD-DC forms again to evaluate changes in symptoms and pain. (Evaluations will be made based on Jaw Functional Limitation Scale (JFLS) scores, pain rating, maximum mouth opening, pain during palpation of the masseter muscle, and pain during palpation of the temporal muscle.)
During the same session, a second USG will also be taken. The results obtained will be compared with the initial USG images taken before treatment. In these images, the thickness, length, and elastography values of the masseter and temporal muscles, both at rest and during clenching, will be measured, and the blood flow rates in the arteries will be assessed. Arterial assessment will be based on (Pulsatility Index) PI, (Resistive Index) RI, Peak Systolic Velocity (PS), End Diastolic Velocity (ED) , and Time-averaged maximum speed (TAMAX) values. Thus, the effect of occlusal splint therapy on muscle morphology and blood flow will be evaluated."**
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Female patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.) Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study.
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Exclusion Criteria:
Female patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study will be selected from this patient group.
Other: Ultrasound imaging
To investigate the mechanism of action of occlusal splints, a routinely applied treatment method for myogenic temporomandibular disorders, ultrasound images will be taken from all patients before and after treatment, and measurements will be conducted based on these images.
"Changes observed after treatment in the temporal and masseter muscles, as well as in the blood flow of their associated arteries."
Ultrasound images taken before and after the application of the occlusal splint will be compared to assess the length, elastography, thickness in the open-mouth position, and thickness during clenching of the masseter and temporal muscles. This comparison will determine the effect of occlusal splints on these two muscles. Additionally, blood flow in the facial artery, temporal artery, maxillary artery, and external carotid artery will be examined to evaluate whether the treatment causes any changes in arterial blood flow.
Time frame: 12 weeks
The effect of occlusal splints on clinical symptoms
The effect of the occlusal splint on reducing the patient's muscle pain levels, jaw opening capacity, Jaw Functional Limitation Score (JFLS), and pain levels during palpation of the relevant muscles will be examined.
Time frame: 12 weeks
Plan to share: Undecided
Ran from Feb 2024 to primary completion in Jul 2024, 5 months.
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