Myofascial Pain - Dysfunction Syndrome of TMJNCT06675747
Evaluation of the Effect of Occlusal Splint Use on Masticatory Muscles
An observational study of Myofascial Pain - Dysfunction Syndrome of TMJ, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
"Female patients who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry, with complaints of muscle pain in the maxillofacial region and who are diagnosed with myofascial pain syndrome based on the results of their examination and the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Myofascial Pain - Dysfunction Syndrome of TMJ
- What is being tested?
- Ultrasound imaging
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 20 Aug 2024
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.) Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study.
Who may be able to join
- Female patients who presented with muscle pain complaints to Istanbul University Faculty of Dentistry
- Patients diagnosed with myospasm and/or myofascial pain syndrome in the masseter and/or temporal muscles
- Patients who have not previously received occlusal splint therapy
- Patients without any physical or mental disabilities
- Patients over the age of 18
- Patients with no missing teeth
Who cannot join
- Patients with any temporomandibular disorders (TMD) other than masticatory muscle disorders
- Male patients
- Patients who have previously received any TMD treatment
- Patients under the age of 18
- Patients with any physical or mental disabilities
- Patients with missing teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Evaluation of the Effect of Occlusal Splint Therapy on the Masseter and Temporal Muscles in Patients with Myofascial Pain Syndrome
"Female patients who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry, with complaints of muscle pain in the maxillofacial region and who are diagnosed with myofascial pain syndrome based on the results of their examination and the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form they completed, will be included in the study. Occlusal splint therapy will be initiated for these patients. Before starting occlusal splint therapy, ultrasound images will be taken from the patients. Subsequently, the patients will undergo routine occlusal splint therapy without any intervention in their 12-week treatment process. At the end of the 12-week treatment protocol, during the final control session, patients will fill the TMD-DC form again, and the two forms will be compared to evaluate changes in their clinical symptoms and pain. Additionally, a second ultrasound imaging will be taken during the same session. In this imaging, the thickness and blood flow of the masseter and temporal muscles will be examined, and comparisons will be made with the pre-treatment ultrasound. In this way, the effects of occlusal splints on muscle morphology and blood flow will be evaluated."
Read the detailed description
The study is designed as a prospective observational clinical study. Female patients will be selected from those who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry with various maxillofacial muscle pain complaints. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.)
During the examination of these patients, Temporomandibular Disorders Diagnostic Criteria (TMD-DC) forms will be completed to reach an accurate diagnosis. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study. Individuals participating in the study will be selected from this patient group. Before starting occlusal splint therapy, ultrasound (USG) images will be taken, focusing on the masseter muscle, temporal muscle, facial artery, maxillary artery, temporal artery, and external carotid artery.
The 12-week routine treatment of these patients will proceed without any intervention. At the end of their treatment, when patients return for their final control session, they will complete the TMD-DC forms again to evaluate changes in symptoms and pain. (Evaluations will be made based on Jaw Functional Limitation Scale (JFLS) scores, pain rating, maximum mouth opening, pain during palpation of the masseter muscle, and pain during palpation of the temporal muscle.)
During the same session, a second USG will also be taken. The results obtained will be compared with the initial USG images taken before treatment. In these images, the thickness, length, and elastography values of the masseter and temporal muscles, both at rest and during clenching, will be measured, and the blood flow rates in the arteries will be assessed. Arterial assessment will be based on (Pulsatility Index) PI, (Resistive Index) RI, Peak Systolic Velocity (PS), End Diastolic Velocity (ED) , and Time-averaged maximum speed (TAMAX) values. Thus, the effect of occlusal splint therapy on muscle morphology and blood flow will be evaluated."**
- Being tested
- Ultrasound imaging
- Keywords
- myofascial pain, temporomandibular disorders, occlusal splint, ultrasonography, masseter muscle, temporal muscle
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imagingOther
To investigate the mechanism of action of occlusal splints, a routinely applied treatment method for myogenic temporomandibular disorders, ultrasound images will be taken from all patients before and after treatment, and measurements will be conducted based on these images.
| Study group | Role | What they receive |
|---|---|---|
| study group | Female patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study will be selected from this patient group. Receives: Other: Ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Changes observed after treatment in the temporal and masseter muscles, as well as in the blood flow of their associated arteries."
Ultrasound images taken before and after the application of the occlusal splint will be compared to assess the length, elastography, thickness in the open-mouth position, and thickness during clenching of the masseter and temporal muscles. This comparison will determine the effect of occlusal splints on these two muscles. Additionally, blood flow in the facial artery, temporal artery, maxillary artery, and external carotid artery will be examined to evaluate whether the treatment causes any changes in arterial blood flow.
Measured: 12 weeks
Secondary outcomes (1)
The effect of occlusal splints on clinical symptoms
The effect of the occlusal splint on reducing the patient's muscle pain levels, jaw opening capacity, Jaw Functional Limitation Score (JFLS), and pain levels during palpation of the relevant muscles will be examined.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Feb 2024
- Primary completion1 Jul 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain - Dysfunction Syndrome of TMJStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berk Bilgen, Istanbul University
- Investigators
- Olcay Sakar, Prof. Dr. Lecturer, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675747
- Sponsor's protocol ID
- 2024/03-Rev-1
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yalcin ED, Aslan Ozturk EM. Ultrasonographic evaluation of the effect of splint therapy on masseter muscle and blood flow in patients with bruxism. Cranio. 2025 Jan;43(1):135-143. doi: 10.1080/08869634.2022.2088575. Epub 2022 Jul 11.
PubMed 35816105
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Effect of Occlusal Splint Therapy on the Masseter and Temporal Muscles in Patients with Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06675747
- Acronym / sponsor ID
- 2024/03-Rev-1
- Keywords
- myofascial pain, temporomandibular disorders, occlusal splint, ultrasonography, masseter muscle, temporal muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 5 Nov 2024 (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.
"Female patients who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry, with complaints of muscle pain in the maxillofacial region and who are diagnosed with myofascial pain syndrome based on the results of their examination and the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form they completed, will be included in the study. Occlusal splint therapy will be initiated for these patients. Before starting occlusal splint therapy, ultrasound images will be taken from the patients. Subsequently, the patients will undergo routine occlusal splint therapy without any intervention in their 12-week treatment process. At the end of the 12-week treatment protocol, during the final control session, patients will fill the TMD-DC form again, and the two forms will be compared to evaluate changes in their clinical symptoms and pain. Additionally, a second ultrasound imaging will be taken during the same session. In this imaging, the thickness and blood flow of the masseter and temporal muscles will be examined, and comparisons will be made with the pre-treatment ultrasound. In this way, the effects of occlusal splints on muscle morphology and blood flow will be evaluated."
Detailed description
The study is designed as a prospective observational clinical study. Female patients will be selected from those who applied to the 'Temporomandibular Disorders (TMD) Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry with various maxillofacial muscle pain complaints. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.)
During the examination of these patients, Temporomandibular Disorders Diagnostic Criteria (TMD-DC) forms will be completed to reach an accurate diagnosis. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study. Individuals participating in the study will be selected from this patient group. Before starting occlusal splint therapy, ultrasound (USG) images will be taken, focusing on the masseter muscle, temporal muscle, facial artery, maxillary artery, temporal artery, and external carotid artery.
The 12-week routine treatment of these patients will proceed without any intervention. At the end of their treatment, when patients return for their final control session, they will complete the TMD-DC forms again to evaluate changes in symptoms and pain. (Evaluations will be made based on Jaw Functional Limitation Scale (JFLS) scores, pain rating, maximum mouth opening, pain during palpation of the masseter muscle, and pain during palpation of the temporal muscle.)
During the same session, a second USG will also be taken. The results obtained will be compared with the initial USG images taken before treatment. In these images, the thickness, length, and elastography values of the masseter and temporal muscles, both at rest and during clenching, will be measured, and the blood flow rates in the arteries will be assessed. Arterial assessment will be based on (Pulsatility Index) PI, (Resistive Index) RI, Peak Systolic Velocity (PS), End Diastolic Velocity (ED) , and Time-averaged maximum speed (TAMAX) values. Thus, the effect of occlusal splint therapy on muscle morphology and blood flow will be evaluated."**
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: Ultrasound imagingFemale patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study will be selected from this patient group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients will be selected from those who present with various maxillofacial muscle pain complaints to the 'Temporomandibular Disorders Clinic' at the Department of Prosthodontics, Istanbul University Faculty of Dentistry. Only female patients will be included in the study, as temporomandibular disorders caused by masticatory muscles are observed approximately four times more frequently in women than in men, and for muscle studies, it is recommended to examine a single gender group for scientific consistency. (Studies combining male and female participants have been found to have lower reliability due to significant differences in muscle volume and thickness between genders.) Female patients diagnosed with myofascial pain syndrome and for whom occlusal splint therapy is planned will be included in the study.
Key inclusion criteria (6 listed)
- Female patients who presented with muscle pain complaints to Istanbul University Faculty of Dentistry
- Patients diagnosed with myospasm and/or myofascial pain syndrome in the masseter and/or temporal muscles
- Patients who have not previously received occlusal splint therapy
- Patients without any physical or mental disabilities
- Patients over the age of 18
Key exclusion criteria (6 listed)
- Patients with any temporomandibular disorders (TMD) other than masticatory muscle disorders
- Male patients
- Patients who have previously received any TMD treatment
- Patients under the age of 18
- Patients with any physical or mental disabilities
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 |
|---|---|---|
| Ultrasound imagingTo investigate the mechanism of action of occlusal splints, a routinely applied treatment method for myogenic temporomandibular disorders, ultrasound images will be taken from all patients before and after treatment, and measurements will be conducted based on these images. | Other | study group |
Primary outcome
"Changes observed after treatment in the temporal and masseter muscles, as well as in the blood flow of their associated arteries."
Time frame: 12 weeks
Ultrasound images taken before and after the application of the occlusal splint will be compared to assess the length, elastography, thickness in the open-mouth position, and thickness during clenching of the masseter and temporal muscles. This comparison will determine the effect of occlusal splints on these two muscles. Additionally, blood flow in the facial artery, temporal artery, maxillary artery, and external carotid artery will be examined to evaluate whether the treatment causes any changes in arterial blood flow.
1 secondary outcome
The effect of occlusal splints on clinical symptoms
Time frame: 12 weeks
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 5 Nov 2024.
- Background: PubMed 35816105Yalcin ED, Aslan Ozturk EM. Ultrasonographic evaluation of the effect of splint therapy on masseter muscle and blood flow in patients with bruxism. Cranio. 2025 Jan;43(1):135-143. doi: 10.1080/08869634.2022.2088575. Epub 2022 Jul 11.
- Individual participant dataSharing planned: Undecided
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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.
Olcay Sakar, Prof. Dr. Lecturer study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain - Dysfunction Syndrome of TMJ, run by Istanbul University 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 6 inclusion and 6 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 5 Nov 2024. 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?
"Changes observed after treatment in the temporal and masseter muscles, as well as in the blood flow of their associated arteries." (time frame: 12 weeks). 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 NCT06675747, which also lists 1 linked publication.
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 5 Nov 2024.