Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-11-01

Brief Summary

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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.

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Detailed Description

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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

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Myofacial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A prospective randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Occlusal Splint Group

Only occlusal splint was made for this patients.

Group Type ACTIVE_COMPARATOR

Occlusal splint treatment

Intervention Type DEVICE

Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.

Masticatory muscle injection group

Only intramuscular injection was applied to this patients. Intramuscular injectable form of Lidocaine Hydrochloride (20mg/ml, Jetokain Simplex, ADEKA, Samsun, Turkey) was injected. 0,3 ml was injected to all trigger points.

Group Type ACTIVE_COMPARATOR

Masticatory muscle injection

Intervention Type PROCEDURE

Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week.

Occlusal splint and masticatory muscle injection combination group

Intramuscular injectable form of Lidocaine Hydrochloride (20mg/ml, Jetokain Simplex, ADEKA, Samsun, Turkey) was injected. 0,3 ml was injected to all trigger points. Patients were started to use their occlusal splints in the evening of the injection day.

Group Type ACTIVE_COMPARATOR

Combination of occlusal splint and masticatory muscle injection treatments

Intervention Type COMBINATION_PRODUCT

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.

Control group

16 healthy volunteers was involved. Not given any treatment to these volunteers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Occlusal splint treatment

Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.

Intervention Type DEVICE

Masticatory muscle injection

Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week.

Intervention Type PROCEDURE

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes