Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

Myofacial Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05228327
• Other study ID #: 66291034-604.01.01-E.66330
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: January 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain
• Myofacial Pain

Intervention

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

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.

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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Dental School	Istanbul	Unkapani

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Bilici IS, Emes Y, Aybar B, Yalçin 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):916-92 — View Citation

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. Review. — View Citation

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 Radio — View Citation

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 — View Citation

Ozkan F, Cakir Özkan 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. — View Citation

Öztürk M, Çaliskan 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 202 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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