Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
NCT07090551

Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain

Led by Istanbul University · Updated on 2026-05-05

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study group will be selected from patients who previously presented with various temporomandibular disorder (TMD) complaints to the "Temporomandibular Disorders Clinic" of the Department of Complete and Removable Dentures at the Faculty of Dentistry, Istanbul University. During routine examinations, TMD-DC (Diagnostic Criteria for Temporomandibular Disorders) forms are completed to aid in achieving an accurate diagnosis. Subsequently, patients suspected of having TMD of masticatory muscle origin but without a definitive diagnosis are routinely referred for ultrasonographic (USG) imaging. Patients meeting these criteria will be included in the study. Participants will be divided into two groups. The first group will consist of patients who have already undergone USG imaging during their routine examination, have been definitively diagnosed with masticatory muscle disorders based on clinical and radiographic findings, and have initiated routine occlusal splint therapy in the clinic. The 12-week treatment process of these patients will not be altered in any way. At the final follow-up session after the 12-week routine treatment protocol, the TMD-DC form completed at baseline will be re-administered, and the two forms will be compared to evaluate changes in symptoms and pain levels. Another USG imaging will also be performed at this session. The second group, serving as the control group, will include patients who have previously undergone USG imaging during routine examination and have received a definitive diagnosis of masticatory muscle disorders based on clinical and radiographic evaluations, but have not yet begun treatment. Patients whose turn for treatment begins during the study period will be excluded from this group. At the end of the 12-week period, the TMD-DC form will be re-administered, and a second USG imaging will be performed. This process will not interfere with the patients' position in the treatment queue, and treatment will commence as scheduled. In the second USG session, changes in the thickness and elasticity of the masseter, temporalis, trapezius, sternocleidomastoid, and splenius capitis muscles will be assessed by comparing the two imaging records.

CONDITIONS

Official 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

Eligible

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
Not Eligible

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

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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

CONTACT

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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