NCT05228327

Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

Evaluation of the Effects of Occlusal Splint and Intramuscular Injection in Patients With Myofascial Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Myofascial pain is one of the common symptoms in patients with temporomandibular joint disorders. Occlusal splint use, trigger point injections and the combination of this two methods are primary treatment options. Patients were divided into 3 groups and this three treatment was applied. We aimed to investigate the clinical and ultrasonographic effects of the treatments. Patients in the treatment groups were reexamined at 1st and 3rd months, and their clinic and ultrasonographic records were repeated. 16 healthy volunteers were also included in the study. No treatment was applied, only clinical and ultrasonographic records were taken once.

Detailed description

48 patients who had myofacial pain and were diagnosed with according to Diagnostic Criteria for Temporomandibular Disorders were included in the study. There were 16 patients in each group. Group 1 was treated with occlusal splint, Group 2 was treated with occlusal splint and masseter muscle lidocaine injection, Group 3 was treated with masseter muscle lidocaine injection and Group 4 consisted of healthy volunteers. Visual analogue scale used for pain evaluation. Also, maximum mouth opening, lateral and protrusion movements of all groups were measured before any treatment. Masseter muscle volume was evaluated by ultrasonography whereas masseter muscle elasticity was evaluated by elastography before the masseter muscle lidocaine injection and occlusal splint treatment. In Group 2 and Group 3, masseter muscle injections were repeated two more times, on 7th and 14th days. Clinical and ultrasonographic measurements were repeated at 1st and 3rd months.

Conditions

• Myofacial Pain

Interventions

Type	Name	Description
DEVICE	Occlusal splint treatment	Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.
PROCEDURE	Masticatory muscle injection	Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week.
COMBINATION_PRODUCT	Combination of occlusal splint and masticatory muscle injection treatments	Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Occlusal splint was also made and they started to use the day which first injection was made. And continue to use the occlusal splint for 3 months. Injection was repeated 3 times, once a week.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-08-01
• Completion: 2021-11-01
• First posted: 2022-02-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: Turkey (Türkiye)