Tinnitus, SubjectiveNCT05830604
Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders
A study testing Occlusal Splint Treatment- Non Invasive treatment in people with Tinnitus, Subjective and Temporomandibular Disorder, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Treatment of Temporomandibular Joint Disorder can help reduce subjective tinnitus levels. This treatment changes the electrical activity of the patient's chewing muscles. For this reason, the relationship between muscular change and tinnitus levels can be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective, Temporomandibular Disorder
- What is being tested?
- Occlusal Splint Treatment- Non Invasive treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2021to 21 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Patients with chronic subjective tinnitus
- Patients with Wilkes Stage 1-2
Who cannot join
- Patients with Wilkes Stage 3-4-5
- Patients with tinnitus due to audiological, neurological, metabolic or pathological reasons
- Patients with objective tinnutus
- Patients with normal tinnitus
- Mentally retarded patients
- Hearing loss, use of ototoxic drugs
Show all 13Show fewer
- Those with ear diseases such as acute ostitis media, perforated tympanic membrane
- Those with Meniere's disease
- Patients with middle ear pathology
- Those with intracranial pathology
- Those with traumatic cervical spine injury
- Patients with severe depression diagnosed by a psychologist
- Patients who have received TMB treatment in the last two months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Science University
Kütahya, 43100
About this study
Treatment of Temporomandibular Joint Disorder can help reduce subjective tinnitus levels. This treatment changes the electrical activity of the patient's chewing muscles. For this reason, the relationship between muscular change and tinnitus levels can be evaluated.
Read the detailed description
The study will be conducted with patients who routinely apply to Kütahya Health Sciences University Faculty of Dentistry. 70 patients with temporomandibular disease accompanied by tinnitus and bruxism will be included in the study. Demographic data such as age, gender, and systemic disease, drug and trauma history data will be collected.
TMD findings of the patients will be classified according to Wilkes classification. The Wilkes classification is as follows:
- Stage 1 (early period): No pain or limitation of jaw movements, only reciprocal click during or after chewing. Mild anterior disc displacement in radiological evaluation.
- Stage 2 (early/intermediate): Mild to moderate pain with reciprocal clicking and periodic locking. Change in disc position.
- Stage 3 (intermediate): Joint tenderness with frequent pain. Ongoing crash. On the radiological image, changes in disc position and deformation with adhesions.
- Stage 4 (intermediate/late): Chronic pain that gets worse from time to time and limitation in jaw movements. Change in the shape and position of the disc and the shape of the condyle. Multiple adhesions with hard tissue changes.
- Stage 5 (late stage): pain that occurs from time to time with crepitation.
Bruxism data (time of onset, whether it is felt during the day/night, fatigue, difficulty in opening the mouth in the morning, stressful period) are questioned and examination findings (disc displacement, masseter hypertrophy on inspection, linea alba, attrition of teeth, fractures in restorations and teeth, muscle and joint pain) , facial asymmetry, mouth opening) will be recorded. The characteristics of tinnitus (objective/subjective, duration, in which ear, increasing and decreasing factors, type) and hearing loss, vertigo will be questioned.
Patients will be divided into two groups. Group I will consist of Wilkes Stage 1-2 patients with temporomandibular intra-articular disorder. Group II will consist of patients with both Wilkes Stage 1-2 temporomandibular intra-articular disorder and bruxism.
In order to measure the muscle strength of the patients before the treatment, EMG containing right-left M. Masseters will be taken in order to easily reach the chewing muscles and to minimize the patient's discomfort. The analog EMG signal will be amplified using a differential amplifier with a high common-mode rejection ratio (bandwidth 5 KHz, peak-to-peak input range 200 μV). The average of the signals is over 500 ms. (Micromed, Italy)
Superficial EMG will be taken following the following protocol:
To reduce skin impedance, the skin will be cleaned before electrode placement and recordings will be made after 5-6 minutes.
Superficial electrodes will be placed on the right and left masseter muscles, with the upper pole of the electrode parallel to the intersection between the tragus-labial commissura and the exocantion-gonion lines. The grounding electrode will be placed in the forehead area.
For all tests, patients will be seated with their head unsupported and asked to maintain a natural upright position.
To avoid any effects of fatigue, a rest period of at least 3 minutes will be allowed between tests. The average EMG potential for each of the muscles will be set to 100%.
To standardize EMG potentials, two 10 mm thick cotton rolls will be placed on each subject's mandibular first and second molars, and maximum voluntary clamping of 5 seconds will be recorded. For 5 seconds, the patient will be encouraged to maintain the same level of contraction. EMG data analysis for all tests, the best 3-s period (the one with the most stable signal) will be automatically selected by the software and used for all subsequent analysis.
Electromyographic activity will then be recorded with a maximum voluntary squeeze at the intercuspal position; The patient will be invited to squeeze as hard as possible and maintain the same level of contraction for 5 seconds. Electromyographic activity will also be taken again while the patient is at rest.
For each subject, the EMG potentials of the analyzed muscles recorded during the maximum voluntary clamping tests will be expressed as a percentage of the average potential recorded during the standardization test (maximum voluntary clamping on cotton rolls).
(μV/μV×100). To assess muscle symmetry, the EMG waves of the masseter muscles will then be compared by calculating a percent overlap coefficient (POC, %). POC is an index of the symmetrical distribution of muscle activity determined by occlusion. The index ranges from 0% to 100%: a POC of 100% will be achieved when two paired muscles contract with perfect symmetry.
Tinnitus and bruxism will be evaluated by the patient with the VAS score. Tinnitus level will additionally be measured with the Tinnitus Handicap Inventory. Then, an occlusal splint will be prepared for the patients. It will be recommended to use them for 24 weeks. Postoperative EMG, Tinnitus Handicap Inventory and VAS scores will be re-evaluated after the use of the occlusal splint.
The obtained data beam when; Age, gender, disease findings, preoperative and postoperative Tinnitus Handicap Inventory and VAS scores, masseter and temporal muscle strength in EMG will be compared and evaluated.
- Conditions
- Tinnitus, Subjective, Temporomandibular Disorder
- Being tested
- Occlusal Splint Treatment- Non Invasive treatment
- Medical subject headings
- Tinnitus, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal Splint Treatment- Non Invasive treatmentProcedure or surgery
Each patient in the study had temporomandibular disorder. The first-line routine treatment of this disease is an occlusal splint. This treatment was applied to each patient. Surgical intervention was not performed.
| Study group | Role | What they receive |
|---|---|---|
| TMD Wilkes Stage I-II and Subjective Tinnitus | Active comparator | Patients with subjective tinnitus and temporomandibular disorder. It was treated with an occlusal splint. Receives: Procedure: Occlusal Splint Treatment- Non Invasive treatment |
| TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism | Active comparator | Patients with subjective tinnitus and temporomandibular disorder and bruxism. It was treated with an occlusal splint. Receives: Procedure: Occlusal Splint Treatment- Non Invasive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseters Activity
To evaluate the symmetry and electrical activity of masseters by surface EMG
Measured: 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start21 Dec 2021
- Primary completion21 Jun 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkan Altay, DDS, Kutahya Health Sciences University
- Investigators
- Elif Çoban, DDS, Principal investigator, https://avesis.ksbu.edu.tr/elif.coban/iletisimMehmet Ç. Ulucan, DDS, Principal investigator, https://avesis.ksbu.edu.tr/mehmetcagatay.ulucanSelver S. Başak, DDS, Principal investigator, https://avesis.ksbu.edu.tr/selversuna.basakBerceste Güler, DDS, Principal investigator, https://avesis.ksbu.edu.tr/berceste.gulerMerve Akdeniz Leblebiciler, MD, Principal investigator, https://avesis.ksbu.edu.tr/merve.akdenizleblebicierVural Kavuncu, MD, Principal investigator, https://avesis.ksbu.edu.tr/vural.kavuncu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830604
- Sponsor's protocol ID
- 2021-09/07
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05830604
- Acronym / sponsor ID
- 2021-09/07
- Conditions
- Tinnitus, Subjective, Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 26 Apr 2023 (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.
Treatment of Temporomandibular Joint Disorder can help reduce subjective tinnitus levels. This treatment changes the electrical activity of the patient's chewing muscles. For this reason, the relationship between muscular change and tinnitus levels can be evaluated.
Detailed description
The study will be conducted with patients who routinely apply to Kütahya Health Sciences University Faculty of Dentistry. 70 patients with temporomandibular disease accompanied by tinnitus and bruxism will be included in the study. Demographic data such as age, gender, and systemic disease, drug and trauma history data will be collected.
TMD findings of the patients will be classified according to Wilkes classification. The Wilkes classification is as follows:
- Stage 1 (early period): No pain or limitation of jaw movements, only reciprocal click during or after chewing. Mild anterior disc displacement in radiological evaluation.
- Stage 2 (early/intermediate): Mild to moderate pain with reciprocal clicking and periodic locking. Change in disc position.
- Stage 3 (intermediate): Joint tenderness with frequent pain. Ongoing crash. On the radiological image, changes in disc position and deformation with adhesions.
- Stage 4 (intermediate/late): Chronic pain that gets worse from time to time and limitation in jaw movements. Change in the shape and position of the disc and the shape of the condyle. Multiple adhesions with hard tissue changes.
- Stage 5 (late stage): pain that occurs from time to time with crepitation.
Bruxism data (time of onset, whether it is felt during the day/night, fatigue, difficulty in opening the mouth in the morning, stressful period) are questioned and examination findings (disc displacement, masseter hypertrophy on inspection, linea alba, attrition of teeth, fractures in restorations and teeth, muscle and joint pain) , facial asymmetry, mouth opening) will be recorded. The characteristics of tinnitus (objective/subjective, duration, in which ear, increasing and decreasing factors, type) and hearing loss, vertigo will be questioned.
Patients will be divided into two groups. Group I will consist of Wilkes Stage 1-2 patients with temporomandibular intra-articular disorder. Group II will consist of patients with both Wilkes Stage 1-2 temporomandibular intra-articular disorder and bruxism.
In order to measure the muscle strength of the patients before the treatment, EMG containing right-left M. Masseters will be taken in order to easily reach the chewing muscles and to minimize the patient's discomfort. The analog EMG signal will be amplified using a differential amplifier with a high common-mode rejection ratio (bandwidth 5 KHz, peak-to-peak input range 200 μV). The average of the signals is over 500 ms. (Micromed, Italy)
Superficial EMG will be taken following the following protocol:
To reduce skin impedance, the skin will be cleaned before electrode placement and recordings will be made after 5-6 minutes.
Superficial electrodes will be placed on the right and left masseter muscles, with the upper pole of the electrode parallel to the intersection between the tragus-labial commissura and the exocantion-gonion lines. The grounding electrode will be placed in the forehead area.
For all tests, patients will be seated with their head unsupported and asked to maintain a natural upright position.
To avoid any effects of fatigue, a rest period of at least 3 minutes will be allowed between tests. The average EMG potential for each of the muscles will be set to 100%.
To standardize EMG potentials, two 10 mm thick cotton rolls will be placed on each subject's mandibular first and second molars, and maximum voluntary clamping of 5 seconds will be recorded. For 5 seconds, the patient will be encouraged to maintain the same level of contraction. EMG data analysis for all tests, the best 3-s period (the one with the most stable signal) will be automatically selected by the software and used for all subsequent analysis.
Electromyographic activity will then be recorded with a maximum voluntary squeeze at the intercuspal position; The patient will be invited to squeeze as hard as possible and maintain the same level of contraction for 5 seconds. Electromyographic activity will also be taken again while the patient is at rest.
For each subject, the EMG potentials of the analyzed muscles recorded during the maximum voluntary clamping tests will be expressed as a percentage of the average potential recorded during the standardization test (maximum voluntary clamping on cotton rolls).
(μV/μV×100). To assess muscle symmetry, the EMG waves of the masseter muscles will then be compared by calculating a percent overlap coefficient (POC, %). POC is an index of the symmetrical distribution of muscle activity determined by occlusion. The index ranges from 0% to 100%: a POC of 100% will be achieved when two paired muscles contract with perfect symmetry.
Tinnitus and bruxism will be evaluated by the patient with the VAS score. Tinnitus level will additionally be measured with the Tinnitus Handicap Inventory. Then, an occlusal splint will be prepared for the patients. It will be recommended to use them for 24 weeks. Postoperative EMG, Tinnitus Handicap Inventory and VAS scores will be re-evaluated after the use of the occlusal splint.
The obtained data beam when; Age, gender, disease findings, preoperative and postoperative Tinnitus Handicap Inventory and VAS scores, masseter and temporal muscle strength in EMG will be compared and evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMD Wilkes Stage I-II and Subjective Tinnitus | Active comparator | Procedure: Occlusal Splint Treatment- Non Invasive treatmentPatients with subjective tinnitus and temporomandibular disorder. It was treated with an occlusal splint. |
| TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism | Active comparator | Procedure: Occlusal Splint Treatment- Non Invasive treatmentPatients with subjective tinnitus and temporomandibular disorder and bruxism. It was treated with an occlusal splint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients with chronic subjective tinnitus
- Patients with Wilkes Stage 1-2
Key exclusion criteria (13 listed)
- Patients with Wilkes Stage 3-4-5
- Patients with tinnitus due to audiological, neurological, metabolic or pathological reasons
- Patients with objective tinnutus
- Patients with normal tinnitus
- Mentally retarded patients
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 Treatment- Non Invasive treatmentEach patient in the study had temporomandibular disorder. The first-line routine treatment of this disease is an occlusal splint. This treatment was applied to each patient. Surgical intervention was not performed. | Procedure or surgery | TMD Wilkes Stage I-II and Subjective Tinnitus, TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism |
Primary outcome
Masseters Activity
Time frame: 6th months
To evaluate the symmetry and electrical activity of masseters by surface EMG
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 26 Apr 2023.
- 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.
Elif Çoban, DDS principal investigator
https://avesis.ksbu.edu.tr/elif.coban/iletisim
Mehmet Ç. Ulucan, DDS principal investigator
https://avesis.ksbu.edu.tr/mehmetcagatay.ulucan
Selver S. Başak, DDS principal investigator
https://avesis.ksbu.edu.tr/selversuna.basak
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- Non Invasive treatment in people with Tinnitus, Subjective and Temporomandibular Disorder, run by Kutahya Health Sciences 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 3 inclusion and 13 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 26 Apr 2023. 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?
Masseters Activity (time frame: 6th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2023.