Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

January 6, 2025 updated by: reyhansaglam, Istanbul Medipol University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Unkapani
      • Istanbul, Unkapani, Turkey, 34083
        • Istanbul Medipol University Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Occlusal Splint Group
Only occlusal splint was made for this patients.
Device: Occlusal splint treatment
Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.
Active Comparator: 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.
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.
Active Comparator: 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.
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.
No Intervention: Control group
16 healthy volunteers was involved. Not given any treatment to these volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before the treatment (day 0), in the 1st and 3rd months of the treatment
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)
Before the treatment (day 0), in the 1st and 3rd months of the treatment
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.
Before the treatment (day 0), in the 1st and 3rd months of the treatment
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
Before the treatment (day 0), in the 1st and 3rd months of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Director: Reyhan Saglam, PhD, Medipol University
  • Study Chair: Irmak Durur Subasi, Prof, Medipol University
  • Study Chair: Gulsum Sayin Ozel, Assis. Prof, Medipol University
  • Study Chair: Cagri Delilbasi, Prof, Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66291034-604.01.01-E.66330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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