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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
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Active Comparator

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

First Posted
January 11, 2022
Last Updated
February 9, 2022
Sponsor
Istanbul Medipol University Hospital
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Arm Title
Occlusal splint and masticatory muscle injection combination group
Arm Type
Active Comparator
Arm Description
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.
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
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
No
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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