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Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders

Primary Purpose

Tinnitus, Subjective, Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Occlusal Splint Treatment- Non Invasive treatment
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients older than 18 years Patients with chronic subjective tinnitus Patients with Wilkes Stage 1-2 Exclusion Criteria: 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 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

Sites / Locations

  • Kütahya Health Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TMD Wilkes Stage I-II and Subjective Tinnitus

TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism

Arm Description

Patients with subjective tinnitus and temporomandibular disorder. It was treated with an occlusal splint.

Patients with subjective tinnitus and temporomandibular disorder and bruxism. It was treated with an occlusal splint.

Outcomes

Primary Outcome Measures

Masseters Activity
To evaluate the symmetry and electrical activity of masseters by surface EMG

Secondary Outcome Measures

Full Information

First Posted
March 16, 2023
Last Updated
April 24, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05830604
Brief Title
Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders
Official Title
Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective, Temporomandibular Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMD Wilkes Stage I-II and Subjective Tinnitus
Arm Type
Active Comparator
Arm Description
Patients with subjective tinnitus and temporomandibular disorder. It was treated with an occlusal splint.
Arm Title
TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism
Arm Type
Active Comparator
Arm Description
Patients with subjective tinnitus and temporomandibular disorder and bruxism. It was treated with an occlusal splint.
Intervention Type
Procedure
Intervention Name(s)
Occlusal Splint Treatment- Non Invasive treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Masseters Activity
Description
To evaluate the symmetry and electrical activity of masseters by surface EMG
Time Frame
6th months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years Patients with chronic subjective tinnitus Patients with Wilkes Stage 1-2 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Çoban, DDS
Organizational Affiliation
https://avesis.ksbu.edu.tr/elif.coban/iletisim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Ç. Ulucan, DDS
Organizational Affiliation
https://avesis.ksbu.edu.tr/mehmetcagatay.ulucan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Selver S. Başak, DDS
Organizational Affiliation
https://avesis.ksbu.edu.tr/selversuna.basak
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berceste Güler, DDS
Organizational Affiliation
https://avesis.ksbu.edu.tr/berceste.guler
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Merve Akdeniz Leblebiciler, MD
Organizational Affiliation
https://avesis.ksbu.edu.tr/merve.akdenizleblebicier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vural Kavuncu, MD
Organizational Affiliation
https://avesis.ksbu.edu.tr/vural.kavuncu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kütahya Health Science University
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders

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