Skip to main content
OpenTrials
Completed

NCT Number: NCT05228327

Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Dental School

Istanbul, Unkapani, 34083, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occlusal splint treatment

Device

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

Masticatory muscle injection

Procedure

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

Combination of occlusal splint and masticatory muscle injection treatments

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.

Primary outcomes

  1. The change of the elasticity of masseter muscle

    Time frame: Before the treatment (day 0), in the 1st and 3rd months of the treatment

    masseter muscle elasticity was evaluated by shear-wave sonoelastography

  2. The change of the pain score

    Time frame: Before the treatment (day 0), in the 1st and 3rd months of the treatment

    Severity of the pain evaluated by the visual analog scale (VAS), rated from 0 (no pain) to 10 (the worst pain)

  3. The change of the maximum mouth opening

    Time frame: Before the treatment (day 0), in the 1st and 3rd months of the treatment

    maximum mouth opening was measured by the reference of right upper and lower central incisors.

  4. The change of the volume of masseter muscle

    Time frame: Before the treatment (day 0), in the 1st and 3rd months of the treatment

    masseter muscle volume was measured by ultrasonography

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2022
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.