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Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

Primary Purpose

Myofacial Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Occlusal splint treatment

Masticatory muscle injection

Combination of occlusal splint and masticatory muscle injection treatments

About this trial

This is an interventional treatment trial for Myofacial Pain focused on measuring Myofacial Pain, Trigger point injection, Occlusal splint, Ultrasonography, Elastography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Istanbul Medipol University Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Arm Label

Occlusal Splint Group

Masticatory muscle injection group

Occlusal splint and masticatory muscle injection combination group

Control group

Arm Description

Only occlusal splint was made for this patients.

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.

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.

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

Outcomes

Primary Outcome Measures

The change of the elasticity of masseter muscle

masseter muscle elasticity was evaluated by shear-wave sonoelastography

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)

The change of the maximum mouth opening

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

The change of the volume of masseter muscle

masseter muscle volume was measured by ultrasonography

Secondary Outcome Measures

Full Information

NCT ID

NCT05228327

First Posted

January 11, 2022

Last Updated

February 9, 2022

Sponsor

Istanbul Medipol University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05228327

Brief Title

Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

August 1, 2021 (Actual)

Study Completion Date

November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myofacial Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

A prospective randomized controlled clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Occlusal Splint Group

Arm Type

Active Comparator

Arm Description

Only occlusal splint was made for this patients.

Arm Title

Masticatory muscle injection group

Arm Type

Active Comparator

Arm Description

Arm Title

Occlusal splint and masticatory muscle injection combination group

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Occlusal splint treatment

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Masticatory muscle injection

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

Combination of occlusal splint and masticatory muscle injection treatments

Intervention Description

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 Outcome Measure Information:

Title

The change of the elasticity of masseter muscle

Description

masseter muscle elasticity was evaluated by shear-wave sonoelastography

Time Frame

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

Title

The change of the pain score

Description

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

Time Frame

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

Title

The change of the maximum mouth opening

Description

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

Time Frame

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

Title

The change of the volume of masseter muscle

Description

masseter muscle volume was measured by ultrasonography

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reyhan Saglam, PhD

Organizational Affiliation

Medipol University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Irmak Durur Subasi, Prof

Organizational Affiliation

Medipol University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gulsum Sayin Ozel, Assis. Prof

Organizational Affiliation

Medipol University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Cagri Delilbasi, Prof

Organizational Affiliation

Medipol University

Official's Role

Study Chair

Facility Information:

Facility Name

Istanbul Medipol University Dental School

City

Istanbul

State/Province

Unkapani

ZIP/Postal Code

34083

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33417097

Citation

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.

Results Reference

result

PubMed Identifier

32150452

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 Radiol. 2020 Dec 1;49(8):20200024. doi: 10.1259/dmfr.20200024. Epub 2020 Mar 9. Erratum In: Dentomaxillofac Radiol. 2022 Sep 1;51(7):20200024c.

Results Reference

result

PubMed Identifier

33273992

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 Nov 12;2020:4184268. doi: 10.1155/2020/4184268. eCollection 2020.

Results Reference

result

PubMed Identifier

29745983

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.

Results Reference

result

PubMed Identifier

28920539

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. Epub 2017 Sep 18.

Results Reference

result

PubMed Identifier

21935818

Citation

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.

Results Reference

result

PubMed Identifier

29692327

Citation

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.

Results Reference

result

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Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

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