Evaluation of the Effect of Occlusal Splint Use on Masticatory Muscles

NCT06675747 | Completed

• 1 other identifier: 2024/03-Rev-1
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

"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."

Conditions

Myofascial Pain - Dysfunction Syndrome of TMJ

Keywords

myofascial pain; temporomandibular disorders; occlusal splint; ultrasonography; masseter muscle; temporal muscle

Outcome Measures

Primary Outcomes (1)

• "Changes observed after treatment in the temporal and masseter muscles, as well as in the blood flow of their associated arteries."

  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 Outcomes (1)

• The effect of occlusal splints on clinical symptoms

  12 weeks

Study Arms (1)

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

Interventions

Ultrasound imaging OTHER

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.

study group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females were eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Olcay Sakar, Prof. Dr. Lecturer

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD DDS, Research Assistant at Department of Prosthodontics

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: February 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 20, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

TU (1)