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

May 2, 2026 updated by: Berk Bilgen, Istanbul University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul University Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • berk bilgen, phd
        • Sub-Investigator:
          • enes akpınar, dds
        • Sub-Investigator:
          • olcay şakar, phd, prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
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.
Experimental: occlusal splint group
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
Patients with myofascial pain will receive occlusal splint therapy, which is a clinically accepted treatment method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 mouths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: berk bilgen, phd, Istanbul University
  • Study Director: olcay şakar, phd, prof., Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

May 5, 2026

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

July 21, 2025

First Posted (Actual)

July 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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