Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

NCT05228327 | Completed DMC

• 1 other identifier: 66291034-604.01.01-E.66330
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofacial Pain

Keywords

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

Outcome Measures

Primary Outcomes (4)

• The change of the elasticity of masseter muscle

  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

  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

  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

  masseter muscle volume was measured by ultrasonography

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

Study Arms (4)

Occlusal Splint Group

ACTIVE COMPARATOR

Only occlusal splint was made for this patients.

Device: Occlusal splint treatment

Masticatory muscle injection group

ACTIVE COMPARATOR

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

Occlusal splint and masticatory muscle injection combination group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

Occlusal splint treatment DEVICE

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

Occlusal Splint Group

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.

Masticatory muscle injection group

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.

Occlusal splint and masticatory muscle injection combination group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Dental School

Istanbul, Unkapani, 34083, Turkey (Türkiye)

Location

Related Publications (7)

• Ozturk M, Caliskan E, Habibi HA. Shear wave elastography of temporomandibular joint disc and masseter muscle stiffness in healthy children and adolescents: a preliminary study. Oral Radiol. 2021 Oct;37(4):618-624. doi: 10.1007/s11282-020-00501-7. Epub 2021 Jan 8.

  PMID: 33417097 RESULT

• Olchowy A, Wieckiewicz M, Winocur E, Dominiak M, Dekkers I, Lasecki M, Olchowy C. Great potential of ultrasound elastography for the assessment of the masseter muscle in patients with temporomandibular disorders. A systematic review. Dentomaxillofac Radiol. 2020 Dec 1;49(8):20200024. doi: 10.1259/dmfr.20200024. Epub 2020 Mar 9.

  PMID: 32150452 RESULT

• Olchowy C, Wieckiewicz M, Sconfienza LM, Lasecki M, Seweryn P, Smardz J, Hnitecka S, Dominiak M, Olchowy A. Potential of Using Shear Wave Elastography in the Clinical Evaluation and Monitoring of Changes in Masseter Muscle Stiffness. Pain Res Manag. 2020 Nov 12;2020:4184268. doi: 10.1155/2020/4184268. eCollection 2020.

  PMID: 33273992 RESULT

• Costa YM, Ariji Y, Ferreira DMAO, Bonjardim LR, Conti PCR, Ariji E, Svensson P. Muscle hardness and masticatory myofascial pain: Assessment and clinical relevance. J Oral Rehabil. 2018 Aug;45(8):640-646. doi: 10.1111/joor.12644. Epub 2018 May 28.

  PMID: 29745983 RESULT

• Tuna SH, Celik OE, Ozturk O, Golpinar M, Aktas A, Balcioglu HA, Keyf F, Sahin B. The effects of stabilization splint treatment on the volume of masseter muscle in sleep bruxism patients. Cranio. 2018 Sep;36(5):286-293. doi: 10.1080/08869634.2017.1377433. Epub 2017 Sep 18.

  PMID: 28920539 RESULT

• Ozkan F, Cakir Ozkan N, Erkorkmaz U. Trigger point injection therapy in the management of myofascial temporomandibular pain. Agri. 2011 Jul;23(3):119-25. doi: 10.5505/agri.2011.04796.

  PMID: 21935818 RESULT

• 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.

  PMID: 29692327 RESULT

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Reyhan Saglam, PhD

  Medipol University

  STUDY DIRECTOR

• Irmak Durur Subasi, Prof

  Medipol University

  STUDY CHAIR

• Gulsum Sayin Ozel, Assis. Prof

  Medipol University

  STUDY CHAIR

• Cagri Delilbasi, Prof

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phd

Model Details: A prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 8, 2022
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)