Myofascial Pain Syndrome (MPS)Phase 4NCT07082972
EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
A Phase 4 study testing Botulinum toxin injection, Occlusal splint and Botulinum toxin + Occlusal splint combined in people with Myofascial Pain Syndrome (MPS) and Masticatory Muscle Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Myofascial Pain Syndrome (MPS), Masticatory Muscle Pain
- What is being tested?
- Botulinum toxin injection, Occlusal splint and Botulinum toxin + Occlusal splint combined
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a diagnosis of myofascial pain syndrome
- No missing teeth
- No history of previous temporomandibular disorder treatment
- Absence of an arthrogenic temporomandibular disorder
Who cannot join
- Pregnancy or lactation; osteoporosis and bisphosphonate use
- Previous botulinum toxin injection to the masseter region
- Bleeding disorders or use of anticoagulant medications
- Presence of systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS)
- Active infection, open wound, or dermatological condition in the facial area
- Undergoing other facial aesthetic procedures (e.g., fillers, PRP, etc.) within the last six months
Show all 9Show fewer
- Individuals with severe psychiatric disorders or those on regular psychiatric medications
- Patients who are unlikely to comply with the study protocol or complete the follow-up period
- Individuals with a body mass index (BMI) outside the normal range, including underweight or overweight participants, will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Istanbul, Vezneciler, 34116
Afra Avar, DDS, 05398757502, afraavar@gmail.com
afraavar@gmail.com
About this study
Official title: Evaluation of the Effects of Occlusal Splint and Masseter Botulinum Toxin Injections on Head and Neck Muscles Using Electromyography
This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). MPS is a common subtype of temporomandibular disorders (TMD), frequently involving the masticatory and cervical muscles. Despite various treatment modalities, there is still no universally accepted protocol. In this study, 56 adult participants of both sexes, without missing teeth and within a normal body mass index (BMI) range, will be randomly assigned to four groups: BTX-A injection only, occlusal splint only, combined BTX-A and splint therapy, and an untreated control group. Surface electromyography (EMG) will be used to assess muscle activity in the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. EMG recordings will be performed at baseline, 4 weeks, and 12 weeks after the intervention. Pain levels and symptom severity will be assessed using the DC/TMD symptom questionnaire and the Visual Analog Scale (VAS). BTX-A injections will be administered by a neurology specialist (20 IU per masseter muscle), and occlusal splints will be custom-fabricated and fitted for each participant. This study seeks to determine the neuromuscular effects of these treatments-both alone and in combination-on masticatory and cervical muscles and to provide insight into the development of more comprehensive and effective treatment strategies for MPS.
Read the detailed description
This study is a prospective, randomized, controlled, parallel-group clinical trial designed to investigate the effects of occlusal splints and BTX-A injections in adult patients with myofascial pain syndrome (MPS), as diagnosed by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). A total of 56 adult participants (both male and female) will be recruited and randomly divided into four equal groups (n=14): (1) BTX-A injection only, (2) occlusal splint only, (3) BTX-A combined with occlusal splint, and (4) control group receiving no treatment. All participants must be within the normal BMI range and have complete dentition.
Exclusion criteria include pregnancy or lactation, systemic neuromuscular or bleeding disorders, prior BTX-A treatment in the masseter region, recent facial aesthetic procedures, and any condition that may hinder study compliance.
BTX-A will be injected into the masseter muscles at three standardized sites per side (total 20 IU per muscle) using a 1 ml syringe with a 26-gauge, 13 mm needle. The injections will be performed by a neurologist in a hospital setting. For participants in the occlusal splint group, upper jaw impressions will be taken using alginate, and splints will be fabricated from 2 mm thick hard vinyl acetate sheets. Splints will be positioned intraorally with autopolymerizing acrylic resin to ensure consistent fit and occlusal contact.
EMG measurements will be conducted at Bezmialem Vakıf University using surface electrodes placed over the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. The skin will be cleaned with 70% alcohol, and electrode placement will follow anatomical landmarks. Recordings will be obtained during maximal voluntary clenching with participants seated and relaxed. Measurements will be taken before treatment, at 4 weeks, and at 12 weeks post-intervention to monitor short- and long-term effects.
All patients will complete the DC/TMD symptom questionnaire and rate their pain using a Visual Analog Scale (VAS) at each time point. Statistical analysis will be performed using SPSS v22. Parametric and non-parametric methods will be applied based on data distribution. Intergroup comparisons will be performed using one-way ANOVA or Kruskal-Wallis tests, and intragroup comparisons will utilize repeated measures ANOVA or Friedman tests. Chi-square tests will be used for categorical data. A significance level of p<0.05 will be considered statistically meaningful.
The study was approved by the Clinical Research Ethics Committee of Istanbul University Faculty of Dentistry and will be funded by the university (BAP). All procedures will be carried out under professional supervision to ensure safety and reliability of data collection.
- Being tested
- Botulinum toxin injection, Occlusal splint, Botulinum toxin + Occlusal splint combined
- Keywords
- Myofascial Pain Syndrome (MPS), Botulinum Toxin, Occlusal Splint, Bruxism, Head and neck muscles, Sternocleidomastoid muscle (SCM), Masseter muscle, Splenius capitis muscle, Electromyography
- Medical subject headings
- Myofascial Pain Syndromes, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injectionDrug
Patients will receive a total of 20 units of botulinum toxin type A (Botox) injected into each masseter muscle. The injections will be administered at three standardized sites on each side using a fine needle to ensure accurate delivery. Muscle activity will be recorded using electromyography (EMG) before the injection, and follow-up EMG measurements will be taken at one month and four months post-treatment to evaluate changes in muscle activity and treatment efficacy.
Occlusal splintDevice
Patients with myofascial pain syndrome will receive custom-made occlusal splints to wear during sleep. These splints help reduce abnormal muscle activity and relieve pain by redistributing bite forces. EMG measurements will be taken before and during treatment to monitor changes in muscle activity.
Botulinum toxin + Occlusal splint combinedCombination product
Patients will receive both botulinum toxin injections (20 units per masseter muscle, injected at three standardized points per side) and will use occlusal splints during sleep. EMG measurements will be conducted before treatment, and at follow-up visits to assess the combined effect of pharmacological and mechanical therapy on muscle activity.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin injection group | Experimental | Patients will receive a total of 20 units of botulinum toxin injected into the masseter muscle on each side. EMG measurements will be taken before and after treatment to evaluate changes in muscle activity. Receives: Drug: Botulinum toxin injection |
| Occlusal splint group | Experimental | Patients will use occlusal splints during sleep. EMG recordings will assess the effect of splint therapy on muscle activity. Receives: Device: Occlusal splint |
| Botulinum toxin + Occlusal splint combined group | Experimental | Patients will receive 20 units of botulinum toxin injections into the masseter muscle on each side and use occlusal splints during sleep. EMG will monitor the combined effect on muscle activity. Receives: Combination Product: Botulinum toxin + Occlusal splint combined |
| Control group | No intervention | Patients will not receive any active treatment. EMG measurements will observe natural changes over time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography results
Electromyographic (EMG) recordings will be used to assess changes in electrical activity in the masseter, temporalis, sternocleidomastoid (SCM), trapezius, and splenius capitis muscles. These muscles are often overactive in individuals with bruxism, parafunctional habits, and postural issues.
Baseline EMG recordings will be taken at week 0, with follow-up measurements at the 1st and 12th weeks to observe short- and mid-term effects. EMG activity in the masseter and temporalis muscles will be evaluated to assess changes following botulinum toxin injections, focusing on potential reductions in muscle hyperactivity. Occlusal splint therapy will be analyzed in terms of its effect on normalizing muscle activity over time. The combined treatment group will be examined for additive or prolonged effects. The control group will serve as a reference to monitor natural variations in EMG activity.
Measured: 12 week
Secondary outcomes (2)
Diagnostic Criteria for Temporomandibular Disorders - Clinical Examination Form
Using the DC/TMD Clinical Examination Form, secondary outcomes will be assessed, including the precise location of pain reported by the patients, the characteristics and range of jaw opening movements, as well as the presence and intensity of pain elicited during manual palpation of the masticatory muscles and temporomandibular joint. These evaluations will help to comprehensively understand the functional limitations and pain patterns associated with temporomandibular disorders and will complement the primary outcomes measured in the study.
Measured: 12 week
Evaluation of Pain and Jaw Function as Secondary Outcomes
As another secondary outcome, pain intensity and jaw functional limitations will be evaluated using a validated pain and jaw function limitation questionnaire. This self-reported tool will allow for the assessment of patients' perceived levels of orofacial pain and the impact of temporomandibular disorders on daily jaw functions such as chewing, speaking, and yawning. These data will support the clinical findings and contribute to a more comprehensive understanding of the functional burden caused by myofascial pain.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Syndrome (MPS)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with myofascial pain syndrome will be included, and their muscle activity will be measured using electromyography (EMG).
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berk Bilgen, Istanbul University
- Investigators
- Olcay Şakar, Phd Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082972
- Sponsor's protocol ID
- 2025/150 Rev-1
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi KH, Kwon OS, Kim L, Lee SM, Jerng UM, Jung J. Electromyographic changes in masseter and sternocleidomastoid muscles can be applied to diagnose of temporomandibular disorders: An observational study. Integr Med Res. 2021 Dec;10(4):100732. doi: 10.1016/j.imr.2021.100732. Epub 2021 May 16.
PubMed 34141576Kaya DI, Ataoglu H. Botulinum toxin treatment of temporomandibular joint pain in patients with bruxism: A prospective and randomized clinical study. Niger J Clin Pract. 2021 Mar;24(3):412-417. doi: 10.4103/njcp.njcp_251_20.
PubMed 33723117Yurttutan ME, Tutunculer Sancak K, Tuzuner AM. Which Treatment Is Effective for Bruxism: Occlusal Splints or Botulinum Toxin? J Oral Maxillofac Surg. 2019 Dec;77(12):2431-2438. doi: 10.1016/j.joms.2019.06.005. Epub 2019 Jun 19.
PubMed 31302066
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Occlusal Splint and Masseter Botulinum Toxin Injections on Head and Neck Muscles Using Electromyography
- ClinicalTrials.gov ID
- NCT07082972
- Acronym / sponsor ID
- 2025/150 Rev-1
- Keywords
- Myofascial Pain Syndrome (MPS), Botulinum Toxin, Occlusal Splint, Bruxism, Head and neck muscles, Sternocleidomastoid muscle (SCM), Masseter muscle, Splenius capitis muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
This randomized controlled clinical trial aims to evaluate the individual and combined effects of occlusal splint therapy and botulinum toxin type A (BTX-A) injections into the masseter muscle on the activity of head and neck muscles in patients diagnosed with myofascial pain syndrome (MPS). MPS is a common subtype of temporomandibular disorders (TMD), frequently involving the masticatory and cervical muscles. Despite various treatment modalities, there is still no universally accepted protocol. In this study, 56 adult participants of both sexes, without missing teeth and within a normal body mass index (BMI) range, will be randomly assigned to four groups: BTX-A injection only, occlusal splint only, combined BTX-A and splint therapy, and an untreated control group. Surface electromyography (EMG) will be used to assess muscle activity in the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. EMG recordings will be performed at baseline, 4 weeks, and 12 weeks after the intervention. Pain levels and symptom severity will be assessed using the DC/TMD symptom questionnaire and the Visual Analog Scale (VAS). BTX-A injections will be administered by a neurology specialist (20 IU per masseter muscle), and occlusal splints will be custom-fabricated and fitted for each participant. This study seeks to determine the neuromuscular effects of these treatments-both alone and in combination-on masticatory and cervical muscles and to provide insight into the development of more comprehensive and effective treatment strategies for MPS.
Detailed description
This study is a prospective, randomized, controlled, parallel-group clinical trial designed to investigate the effects of occlusal splints and BTX-A injections in adult patients with myofascial pain syndrome (MPS), as diagnosed by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). A total of 56 adult participants (both male and female) will be recruited and randomly divided into four equal groups (n=14): (1) BTX-A injection only, (2) occlusal splint only, (3) BTX-A combined with occlusal splint, and (4) control group receiving no treatment. All participants must be within the normal BMI range and have complete dentition.
Exclusion criteria include pregnancy or lactation, systemic neuromuscular or bleeding disorders, prior BTX-A treatment in the masseter region, recent facial aesthetic procedures, and any condition that may hinder study compliance.
BTX-A will be injected into the masseter muscles at three standardized sites per side (total 20 IU per muscle) using a 1 ml syringe with a 26-gauge, 13 mm needle. The injections will be performed by a neurologist in a hospital setting. For participants in the occlusal splint group, upper jaw impressions will be taken using alginate, and splints will be fabricated from 2 mm thick hard vinyl acetate sheets. Splints will be positioned intraorally with autopolymerizing acrylic resin to ensure consistent fit and occlusal contact.
EMG measurements will be conducted at Bezmialem Vakıf University using surface electrodes placed over the masseter, temporalis, sternocleidomastoid, splenius capitis, and trapezius muscles. The skin will be cleaned with 70% alcohol, and electrode placement will follow anatomical landmarks. Recordings will be obtained during maximal voluntary clenching with participants seated and relaxed. Measurements will be taken before treatment, at 4 weeks, and at 12 weeks post-intervention to monitor short- and long-term effects.
All patients will complete the DC/TMD symptom questionnaire and rate their pain using a Visual Analog Scale (VAS) at each time point. Statistical analysis will be performed using SPSS v22. Parametric and non-parametric methods will be applied based on data distribution. Intergroup comparisons will be performed using one-way ANOVA or Kruskal-Wallis tests, and intragroup comparisons will utilize repeated measures ANOVA or Friedman tests. Chi-square tests will be used for categorical data. A significance level of p<0.05 will be considered statistically meaningful.
The study was approved by the Clinical Research Ethics Committee of Istanbul University Faculty of Dentistry and will be funded by the university (BAP). All procedures will be carried out under professional supervision to ensure safety and reliability of data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients with myofascial pain syndrome will be included, and their muscle activity will be measured using electromyography (EMG).
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin injection group | Experimental | Drug: Botulinum toxin injectionPatients will receive a total of 20 units of botulinum toxin injected into the masseter muscle on each side. EMG measurements will be taken before and after treatment to evaluate changes in muscle activity. |
| Occlusal splint group | Experimental | Device: Occlusal splintPatients will use occlusal splints during sleep. EMG recordings will assess the effect of splint therapy on muscle activity. |
| Botulinum toxin + Occlusal splint combined group | Experimental | Combination Product: Botulinum toxin + Occlusal splint combinedPatients will receive 20 units of botulinum toxin injections into the masseter muscle on each side and use occlusal splints during sleep. EMG will monitor the combined effect on muscle activity. |
| Control group | No intervention | –Patients will not receive any active treatment. EMG measurements will observe natural changes over time. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having a diagnosis of myofascial pain syndrome
- No missing teeth
- No history of previous temporomandibular disorder treatment
- Absence of an arthrogenic temporomandibular disorder
Key exclusion criteria (9 listed)
- Pregnancy or lactation; osteoporosis and bisphosphonate use
- Previous botulinum toxin injection to the masseter region
- Bleeding disorders or use of anticoagulant medications
- Presence of systemic muscular or neurological diseases (e.g., myasthenia gravis, ALS)
- Active infection, open wound, or dermatological condition in the facial area
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 |
|---|---|---|
| Botulinum toxin injectionPatients will receive a total of 20 units of botulinum toxin type A (Botox) injected into each masseter muscle. The injections will be administered at three standardized sites on each side using a fine needle to ensure accurate delivery. Muscle activity will be recorded using electromyography (EMG) before the injection, and follow-up EMG measurements will be taken at one month and four months post-treatment to evaluate changes in muscle activity and treatment efficacy. | Drug | Botulinum toxin injection group |
| Occlusal splintPatients with myofascial pain syndrome will receive custom-made occlusal splints to wear during sleep. These splints help reduce abnormal muscle activity and relieve pain by redistributing bite forces. EMG measurements will be taken before and during treatment to monitor changes in muscle activity. | Device | Occlusal splint group |
| Botulinum toxin + Occlusal splint combinedPatients will receive both botulinum toxin injections (20 units per masseter muscle, injected at three standardized points per side) and will use occlusal splints during sleep. EMG measurements will be conducted before treatment, and at follow-up visits to assess the combined effect of pharmacological and mechanical therapy on muscle activity. | Combination product | Botulinum toxin + Occlusal splint combined group |
Primary outcome
Electromyography results
Time frame: 12 week
Electromyographic (EMG) recordings will be used to assess changes in electrical activity in the masseter, temporalis, sternocleidomastoid (SCM), trapezius, and splenius capitis muscles. These muscles are often overactive in individuals with bruxism, parafunctional habits, and postural issues. Baseline EMG recordings will be taken at week 0, with follow-up measurements at the 1st and 12th weeks to observe short- and mid-term effects. EMG activity in the masseter and temporalis muscles will be evaluated to assess changes following botulinum toxin injections, focusing on potential reductions in muscle hyperactivity. Occlusal splint therapy will be analyzed in terms of its effect on normalizing muscle activity over time. The combined treatment group will be examined for additive or prolonged effects. The control group will serve as a reference to monitor natural variations in EMG activity.
2 secondary outcomes
Diagnostic Criteria for Temporomandibular Disorders - Clinical Examination Form
Time frame: 12 week
Evaluation of Pain and Jaw Function as Secondary Outcomes
Time frame: 12 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 34141576Choi KH, Kwon OS, Kim L, Lee SM, Jerng UM, Jung J. Electromyographic changes in masseter and sternocleidomastoid muscles can be applied to diagnose of temporomandibular disorders: An observational study. Integr Med Res. 2021 Dec;10(4):100732. doi: 10.1016/j.imr.2021.100732. Epub 2021 May 16.
- Background: PubMed 33723117Kaya DI, Ataoglu H. Botulinum toxin treatment of temporomandibular joint pain in patients with bruxism: A prospective and randomized clinical study. Niger J Clin Pract. 2021 Mar;24(3):412-417. doi: 10.4103/njcp.njcp_251_20.
- Background: PubMed 31302066Yurttutan ME, Tutunculer Sancak K, Tuzuner AM. Which Treatment Is Effective for Bruxism: Occlusal Splints or Botulinum Toxin? J Oral Maxillofac Surg. 2019 Dec;77(12):2431-2438. doi: 10.1016/j.joms.2019.06.005. Epub 2019 Jun 19.
- 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.
Olcay Şakar, Phd Prof. 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?
A Phase 4 study testing Botulinum toxin injection, Occlusal splint and Botulinum toxin + Occlusal splint combined in people with Myofascial Pain Syndrome (MPS) and Masticatory Muscle Pain, 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afra Avar, DDS (+905398757502, afraavar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography results (time frame: 12 week). 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 NCT07082972, which also lists 3 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 24 Jul 2025.