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NCT Number: NCT07090551

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

berk bilgen, phd

PRINCIPAL_INVESTIGATOR

enes akpınar, dds

CONTACT

[email protected]

0090 5395847509

enes akpınar, dds

SUB_INVESTIGATOR

olcay şakar, phd, prof.

SUB_INVESTIGATOR

About this study

The study is designed as a prospective observational clinical research. The study group will consist of patients who previously presented with various temporomandibular disorder (TMD) complaints to the "Temporomandibular Disorders Clinic" of the Department of Prosthodontics at the Faculty of Dentistry, Istanbul University. During routine examinations, patients are asked to complete the TMD-DC (Diagnostic Criteria for Temporomandibular Disorders) forms to facilitate accurate diagnosis. Subsequently, patients who are suspected of having TMD of masticatory muscle origin but for whom a definitive diagnosis cannot be established are routinely referred for ultrasonographic (USG) imaging. Patients who meet these criteria will be included in the study.

Participants will be divided into two groups. The first group will comprise patients who have previously undergone USG imaging for routine diagnostic purposes, have been definitively diagnosed with masticatory muscle disorders based on clinical and radiographic examinations, and have initiated occlusal splint therapy as part of routine clinical care. The 12-week treatment protocol of these patients will not be altered in any way. At the final follow-up session at the end of the 12-week treatment period, the TMD-DC form previously completed at baseline will be re-administered, and the two forms will be compared to evaluate changes in patients' symptoms and pain levels. Additionally, a second USG imaging will be performed at this session.

The second group will consist of patients who have undergone USG imaging for routine diagnostic purposes, have been definitively diagnosed with masticatory muscle disorders based on clinical and radiographic findings, but have not yet begun treatment due to waiting their turn in the treatment queue. Patients who start occlusal splint therapy during the study period will be excluded from the control group. This group will serve as the control group of the study. At the end of the 12-week observation period, participants in this group will again complete the TMD-DC form and undergo a second USG imaging. This process will not affect their place in the treatment queue, and treatment will be initiated when their turn arrives.

In the final USG session, the thickness and elasticity of the masseter, temporalis, trapezius, sternocleidomastoid, and splenius capitis muscles will be compared between the two imaging sessions. In this way, the effects of occlusal splints on the morphology and elasticity of the head and neck muscles will be evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

occlusal splint therapy

Device

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

Primary outcomes

  1. ultrasonography results

    Time frame: 3 months

    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.

Secondary outcomes

  1. dc/tmd form results

    Time frame: 3 mouths

    Through the use of DC/TMD forms, all patients in both groups will undergo assessments of mandibular movements, muscle palpation findings, the degree of functional jaw limitation, depression and anxiety questionnaires, and pain questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

enes akpınar, des

CONTACT

[email protected]

0090 5395847509

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain: An Ultrasonographic Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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