CompletedNot Applicable

Evaluation of the Effect of Occlusal Splint Use on Masticatory Muscles

Turkey (Türkiye)24 participantsStarted 2024-02-01

Plain-language summary

"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."

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female patients who presented with muscle pain complaints to Istanbul University Faculty of Dentistry * Patients diagnosed with myospasm and/or myofascial pain syndrome in the masseter and/or temporal muscles * Patients who have not previously received occlusal splint therapy * Patients without any physical or mental disabilities * Patients over the age of 18 * Patients with no missing teeth Exclusion Criteria: * Patients with any temporomandibular disorders (TMD) other than masticatory muscle disorders * Male patients * Patients who have previously received any TMD treatment * Patients under the age of 18 * Patients with any physical or mental disabilities * Patients with missing teeth

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

"Changes observed after treatment in the temporal and masseter muscles, as well as in the blood flow of their associated arteries."

Timeframe: 12 weeks

Trial details

NCT IDNCT06675747

SponsorIstanbul University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-01

View on ClinicalTrials.gov More Myofascial Pain - Dysfunction Syndrome of TMJ trials