Myofacial PainNCT05228327
Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain
A study testing Occlusal splint treatment, Masticatory muscle injection and Combination of occlusal splint and masticatory muscle injection treatments in people with Myofacial Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofacial Pain
- What is being tested?
- Occlusal splint treatment, Masticatory muscle injection and Combination of occlusal splint and masticatory muscle injection treatments
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Who cannot join
- 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,
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Dental School
Istanbul, Unkapani, 34083
About this study
Official title: 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.
Read the 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.
- Conditions
- Myofacial Pain
- Being tested
- Occlusal splint treatment, Masticatory muscle injection, Combination of occlusal splint and masticatory muscle injection treatments
- Keywords
- Myofacial Pain, Trigger point injection, Occlusal splint, Ultrasonography, Elastography
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal splint treatmentDevice
Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.
Masticatory muscle injectionProcedure or surgery
Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week.
Combination of occlusal splint and masticatory muscle injection treatmentsCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Splint Group | Active comparator | Only occlusal splint was made for this patients. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the elasticity of masseter muscle
masseter muscle elasticity was evaluated by shear-wave sonoelastography
Measured: 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)
Measured: 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.
Measured: 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
Measured: Before the treatment (day 0), in the 1st and 3rd months of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Aug 2020
- Primary completion1 Aug 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A prospective randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reyhansaglam, Istanbul Medipol University Hospital
- Investigators
- Reyhan Saglam, PhD, Study director, Medipol UniversityIrmak Durur Subasi, Prof, Study chair, Medipol UniversityGulsum Sayin Ozel, Assis. Prof, Study chair, Medipol UniversityCagri Delilbasi, Prof, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228327
- Sponsor's protocol ID
- 66291034-604.01.01-E.66330
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33417097Olchowy 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.
PubMed 32150452Olchowy 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.
PubMed 33273992Costa 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.
PubMed 29745983Tuna 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.
PubMed 28920539Ozkan 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.
PubMed 21935818Bilici 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.
PubMed 29692327
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Occlusal Splint and Intramuscular Injection in Patients With Myofascial Pain
- ClinicalTrials.gov ID
- NCT05228327
- Acronym / sponsor ID
- 66291034-604.01.01-E.66330
- Conditions
- Myofacial Pain
- Keywords
- Myofacial Pain, Trigger point injection, Occlusal splint, Ultrasonography, Elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Occlusal Splint Group | Active comparator | Device: Occlusal splint treatmentOnly occlusal splint was made for this patients. |
| Masticatory muscle injection group | Active comparator | Procedure: Masticatory muscle injectionOnly 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. |
| Occlusal splint and masticatory muscle injection combination group | Active comparator | Combination Product: Combination of occlusal splint and masticatory muscle injection treatmentsIntramuscular 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. |
| Control group | No intervention | –16 healthy volunteers was involved. Not given any treatment to these volunteers. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusal splint treatmentOcclusal splint was made for 16 patients and they used just this occlusal splint for 3 months. | Device | Occlusal Splint Group |
| Masticatory muscle injectionLidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week. | Procedure or surgery | Masticatory muscle injection group |
| Combination of occlusal splint and masticatory muscle injection treatmentsLidocaine 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. | Combination product | Occlusal splint and masticatory muscle injection combination group |
Primary outcome
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
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)
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Results publication: PubMed 33417097Ozturk 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 publication: PubMed 32150452Olchowy 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.
- Results publication: PubMed 33273992Olchowy 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 publication: PubMed 29745983Costa 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 publication: PubMed 28920539Tuna 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 publication: PubMed 21935818Ozkan 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 publication: PubMed 29692327Bilici 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reyhan Saglam, PhD study director
Medipol University
Irmak Durur Subasi, Prof study chair
Medipol University
Gulsum Sayin Ozel, Assis. Prof study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal splint treatment, Masticatory muscle injection and Combination of occlusal splint and masticatory muscle injection treatments in people with Myofacial Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the elasticity of masseter muscle (time frame: Before the treatment (day 0), in the 1st and 3rd months of the treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05228327, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.