Evaluation of the Effect of Occlusal Splint Use on Masticatory Muscles

November 4, 2024 updated by: Berk Bilgen, Istanbul University

Ultrasonographic Evaluation of the Effect of Occlusal Splint Therapy on the Masseter and Temporal Muscles in Patients with Myofascial Pain Syndrome

"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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed as a prospective observational clinical study. Female patients will be selected from those who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry with various maxillofacial muscle pain complaints. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.)

During the examination of these patients, Temporomandibular Disorders Diagnostic Criteria (TMD-DC) forms will be completed to reach an accurate diagnosis. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study. Individuals participating in the study will be selected from this patient group. Before starting occlusal splint therapy, ultrasound (USG) images will be taken, focusing on the masseter muscle, temporal muscle, facial artery, maxillary artery, temporal artery, and external carotid artery.

The 12-week routine treatment of these patients will proceed without any intervention. At the end of their treatment, when patients return for their final control session, they will complete the TMD-DC forms again to evaluate changes in symptoms and pain. (Evaluations will be made based on Jaw Functional Limitation Scale (JFLS) scores, pain rating, maximum mouth opening, pain during palpation of the masseter muscle, and pain during palpation of the temporal muscle.)

During the same session, a second USG will also be taken. The results obtained will be compared with the initial USG images taken before treatment. In these images, the thickness, length, and elastography values of the masseter and temporal muscles, both at rest and during clenching, will be measured, and the blood flow rates in the arteries will be assessed. Arterial assessment will be based on (Pulsatility Index) PI, (Resistive Index) RI, Peak Systolic Velocity (PS), End Diastolic Velocity (ED) , and Time-averaged maximum speed (TAMAX) values. Thus, the effect of occlusal splint therapy on muscle morphology and blood flow will be evaluated."**

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University

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
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Female patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.) Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
Female patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study will be selected from this patient group.
Other: Ultrasound imaging
To investigate the mechanism of action of occlusal splints, a routinely applied treatment method for myogenic temporomandibular disorders, ultrasound images will be taken from all patients before and after treatment, and measurements will be conducted based on these images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Changes observed after treatment in the temporal and masseter muscles, as well as in the blood flow of their associated arteries."
Time Frame: 12 weeks
Ultrasound images taken before and after the application of the occlusal splint will be compared to assess the length, elastography, thickness in the open-mouth position, and thickness during clenching of the masseter and temporal muscles. This comparison will determine the effect of occlusal splints on these two muscles. Additionally, blood flow in the facial artery, temporal artery, maxillary artery, and external carotid artery will be examined to evaluate whether the treatment causes any changes in arterial blood flow.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of occlusal splints on clinical symptoms
Time Frame: 12 weeks
The effect of the occlusal splint on reducing the patient's muscle pain levels, jaw opening capacity, Jaw Functional Limitation Score (JFLS), and pain levels during palpation of the relevant muscles will be examined.
12 weeks

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Study Director: Olcay Sakar, Prof. Dr. Lecturer, 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)

February 1, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

August 20, 2024

Study Registration Dates

First Submitted

November 2, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/03-Rev-1

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

product manufactured in and exported from the U.S.

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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