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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05228327
Enrollment
64
Registered
2022-02-08
Start date
2020-08-01
Completion date
2021-11-01
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofacial Pain

Keywords

Myofacial Pain, Trigger point injection, Occlusal splint, Ultrasonography, Elastography

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.

Interventions

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

PROCEDUREMasticatory muscle injection

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

COMBINATION_PRODUCTCombination 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.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A prospective randomized controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The change of the elasticity of masseter muscleBefore the treatment (day 0), in the 1st and 3rd months of the treatmentmasseter muscle elasticity was evaluated by shear-wave sonoelastography
The change of the pain scoreBefore the treatment (day 0), in the 1st and 3rd months of the treatmentSeverity of the pain evaluated by the visual analog scale (VAS), rated from 0 (no pain) to 10 (the worst pain)
The change of the maximum mouth openingBefore the treatment (day 0), in the 1st and 3rd months of the treatmentmaximum mouth opening was measured by the reference of right upper and lower central incisors.
The change of the volume of masseter muscleBefore the treatment (day 0), in the 1st and 3rd months of the treatmentmasseter muscle volume was measured by ultrasonography

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026