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

NCT07090551 | Recruiting

• 1 other identifier: 2025/130
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Myofacial Pain Syndrome; Local Myalgia; Masticatory Muscle Pain; Bruxism

Keywords

myofacial pain syndrome; bruxism; ultrasonography; occlusal splint; masseter muscle; splenius capitis muscle

Outcome Measures

Primary Outcomes (1)

• ultrasonography results

  The masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles will be evaluated using ultrasonography. For each muscle, elastography values, thickness at rest, and thickness during maximum clenching will be measured. All parameters will be recorded both before the initiation of treatment and three months after treatment, and the values will be compared accordingly.

  3 months

Secondary Outcomes (1)

• dc/tmd form results

  3 mouths

Study Arms (2)

control group

NO INTERVENTION

Patients in the control group present with myofascial pain; however, no treatment will be administered to them. Ultrasonographic images taken at baseline and at the end of the three-month period will be compared both within the control group and with the patient group receiving occlusal splint therapy.

occlusal splint group

EXPERIMENTAL

Ultrasonographic imaging will be performed on patients with myofascial pain who undergo occlusal splint therapy, both prior to treatment and at the end of the treatment period (three months after the initiation of therapy). These data will be compared within the treatment group and against the control group.

Device: occlusal splint therapy

Interventions

occlusal splint therapy DEVICE

Patients with myofascial pain will receive occlusal splint therapy, which is a clinically accepted treatment method.

occlusal splint group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Yalcin ED, Aslan Ozturk EM. Ultrasonographic evaluation of the effect of splint therapy on masseter muscle and blood flow in patients with bruxism. Cranio. 2025 Jan;43(1):135-143. doi: 10.1080/08869634.2022.2088575. Epub 2022 Jul 11.

  PMID: 35816105 RESULT

• Bilgen B, Akpinar E, Tepe RD, Karabas HC, Sakar O. Effects of occlusal splint therapy on the masseter and temporalis muscles in female patients with myofascial pain syndrome: An ultrasonographic study. Cranio. 2025 Sep;43(5):868-878. doi: 10.1080/08869634.2025.2490297. Epub 2025 Apr 22.

  PMID: 40264294 RESULT

MeSH Terms

Conditions

Facial Neuralgia; Bruxism

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Tooth Diseases; Habits; Behavior

Study Officials

• berk bilgen, phd

  Istanbul University

  PRINCIPAL INVESTIGATOR

• olcay şakar, phd, prof.

  Istanbul University

  STUDY DIRECTOR

Central Study Contacts

enes akpınar, des

CONTACT

0090 5395847509; enesakpinar@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher performing the ultrasonographic imaging is blinded to the group allocation of the patients. The study is designed as a single-blind trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: Patients who present with various temporomandibular disorder (TMD) complaints to the "Temporomandibular Disorders Clinic" of the Department of Prosthodontics at Istanbul University Faculty of Dentistry undergo routine clinical examinations, during which TMD-DC (Diagnostic Criteria for Temporomandibular Disorders) forms are completed to aid in reaching an accurate diagnosis. Based on clinical findings and form results, patients suspected of having masticatory muscle disorders but lacking a definitive diagnosis are referred for ultrasonographic (USG) imaging to investigate potential myofascial trigger points, pathological changes, or muscle atrophy in the masticatory muscles. Subsequently, USG results are evaluated in conjunction with the clinical findings and TMD-DC assessments to establish a definitive diagnosis. If the presence of myospasm or myofascial pain syndrome originating from the masseter and/or temporalis muscles is confirmed, occlusal splint therapy is init

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: May 5, 2025
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

TU (1)