Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05830604
Other study ID # 2021-09/07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 21, 2021
Est. completion date December 21, 2022

Study information

Verified date April 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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: 1. 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. 2. Stage 2 (early/intermediate): Mild to moderate pain with reciprocal clicking and periodic locking. Change in disc position. 3. Stage 3 (intermediate): Joint tenderness with frequent pain. Ongoing crash. On the radiological image, changes in disc position and deformation with adhesions. 4. 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. 5. 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 21, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Occlusal Splint Treatment- Non Invasive treatment
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.

Locations

Country Name City State
Turkey Kütahya Health Science University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Masseters Activity To evaluate the symmetry and electrical activity of masseters by surface EMG 6th months
See also
  Status Clinical Trial Phase
Recruiting NCT05006963 - Tele-Rehabilitation in Patients With Temporomandibular Dysfunction N/A
Completed NCT04102306 - Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders
Not yet recruiting NCT05297604 - Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders Phase 2
Recruiting NCT06035341 - The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction N/A
Recruiting NCT03849534 - Treatment of Temporomandibular Disorders in Children and Adolsecents N/A
Not yet recruiting NCT05021874 - The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures. N/A
Recruiting NCT05232604 - How is Aerobic Exercise Compared to Localized Pain Relief Exercises in Patients With Jaw Pain and Neck Pain? N/A
Completed NCT04557878 - Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction Phase 2
Completed NCT03726060 - Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders N/A
Not yet recruiting NCT06123351 - Forward Head Posture Correction Impact on Temporomandibular Dysfunction N/A
Completed NCT03619889 - The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder N/A
Completed NCT01000389 - A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism N/A
Completed NCT00743223 - The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder N/A
Completed NCT03300297 - Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder N/A
Completed NCT06065826 - Forward Head Posture and Myogenic TMD Association in Smartphone Overuse
Completed NCT04087005 - Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial N/A
Recruiting NCT03696706 - Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction Phase 2
Completed NCT04041271 - Jaw Kinematics and Muscle Activation in Patients With Non-specific Chronic Neck Pain
Recruiting NCT03096301 - Photobiomodulation in Temporomandibular Disorder N/A
Not yet recruiting NCT06052722 - The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders N/A