Clinical trial NCT05228327: Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain
Official title: Evaluation of the Effects of Occlusal Splint and Intramuscular Injection in Patients With Myofascial Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofacial Pain
Keywords: Myofacial Pain
Trigger point injection
Occlusal splint
Ultrasonography
Elastography
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A prospective randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Indication of muscle pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree,
* Having minimum three trigger points in the masseter muscles on palpation (active or latent),
* No medical or surgical treatment for temporomandibular joint in the last 3 months,
* No history of occlusal splint treatment,
* Not had a masticatory muscle injection or dry needling before,
* Absence of active caries and pulpal lesions,
* No missing teeth other than the third molar,

Exclusion Criteria:

* Intra-Articular Disorders or Degenerative Joint Disease indication according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree,
* Presence of active infection in the masseter trigger point area,
* Being in the mixed dentition period,
* The patient has used an occlusal splint before,
* Known allergy to local anesthetics,
* Having a needle phobia,
* Presence of congenital head and neck deformity,
* Having systemic joint disease,
* Presence of cardiovascular disease, thyroid disease, diabetes, hypertension, renal failure, isolated muscle disease, rheumatological and neurological disease,
* Having a history of trauma in the head and neck region in the last 2 years,
* Presence of malignancy or having undergone head and neck radiotherapy/chemotherapy in the last 2 years,
* Presence of bleeding disorder,
* Use of analgesic, corticosteroid and anticonvulsant drugs,
* Presence of fibromyalgia diagnosis,
* Being treated by a neurologist for neurological disorders and/or neuropathic pain and/or headache,
* Pregnancy or lactation,
* Having a known psychiatric disorder and using antidepressants in the last 6 months,
* Having drug and/or alcohol addiction,
* Being under active orthodontic treatment.

Primary outcomes:
measure: The change of the elasticity of masseter muscle
timeFrame: Before the treatment (day 0), in the 1st and 3rd months of the treatment
measure: The change of the pain score
timeFrame: Before the treatment (day 0), in the 1st and 3rd months of the treatment
measure: The change of the maximum mouth opening
timeFrame: Before the treatment (day 0), in the 1st and 3rd months of the treatment
measure: The change of the volume of masseter muscle
timeFrame: Before the treatment (day 0), in the 1st and 3rd months of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Dental School
state: Unkapani
Study officials:
affiliation: Medipol University
name: Reyhan Saglam, PhD
role: STUDY_DIRECTOR
affiliation: Medipol University
name: Irmak Durur Subasi, Prof
role: STUDY_CHAIR
affiliation: Medipol University
name: Gulsum Sayin Ozel, Assis. Prof
role: STUDY_CHAIR
affiliation: Medipol University
name: Cagri Delilbasi, Prof
role: STUDY_CHAIR
References:
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citation: Bilici IS, Emes Y, Aybar B, Yalcin S. Evaluation of the effects of occlusal splint, trigger point injection and arthrocentesis in the treatment of internal derangement patients with myofascial pain disorders. J Craniomaxillofac Surg. 2018 Jun;46(6):916-922. doi: 10.1016/j.jcms.2018.03.018. Epub 2018 Mar 31.