- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05402228
Investigation of the Aural Symptoms and Dizziness in Patients With Temporomandibular Joint Disorders
120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3) according to DC/TMD axis I diagnostic criteria.
maximum mouth opening, TMJ sound, pain levels, tinnitus, and dizziness are evaluated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3) according to DC/TMD axis I diagnostic criteria.
Demographic data of all patients participating in the study will be obtained. Then, physical examination will reveal maximum mouth opening, right and left lateral movement, deflexion, deviation. Accompanying tinnitus, ear fullness and dizziness will be questioned.
All measurements, including maximum mouth opening, and physical examination will be performed with patients sitting upright in an anatomical position in a chair. All measurements will be performed by the same physical therapist with 7 years of experience in TMD.
In the measurement of maximum mouth opening, patients will be asked to open their mouths as wide as possible. The distance between the anterior incisors is measured with the help of a ruler suitable for millimeter measurement. Maximum mouth opening distance is a physical examination method frequently used to determine the motion and function of the jaw joint. Functional mouth opening is accepted as 35-40 mm (12).
For the evaluation of TMJ sound, the TMJ is palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh is noted.
Pain levels are measured using a 10-point visual analog scale (VAS). The presence of bruxism is determined on physical examination based on the presence of abnormal tooth wear, tooth marks in the buccal region, tooth marks on the tongue, and hypertrophy of the masseter muscle.
The sense of fullness in the ear, tinnitus, and dizzyness, which the patients reported themselves, is questioned. The relationship between having TMD, clinical characteristics and dizziness will be evaluated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kucukcekmece
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Istanbul, Kucukcekmece, Turkey, 34303
- Kanuni Sultan Suleyman Training and Research Hospital
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Istanbul, Kucukcekmece, Turkey, 34307
- Kanuni Sultan Suleyman Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- being 18-65 years of age
- diagnosed with TMD
Exclusion Criteria:
- Lack of cognitive ability to understand test instructions, illliteracy, aphasia, presence of a known psychiatric illness
- Patients under the age of 18 and over the age of 65
- Having another systemic disease that will cause TMD (cancer, rheumatological diseases)
- Presence of disease that will increase a anotherural symptoms or cause d d (presence of disease of vertigo, history of vertigo)
- Presence of a history of cervical pain, cervical spondylosis, cervical disc herniation
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximum mouth opening
Time Frame: 1 day
|
maximum mouth opening
|
1 day
|
right and left lateral movement, deflexion, and deviation
Time Frame: 1 day
|
right and left lateral movement, deflexion, and deviation
|
1 day
|
TMJ sound
Time Frame: 1 day
|
the TMJis palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh was noted.
|
1 day
|
visual analog scale
Time Frame: 1 day
|
It is use for evaluate the pain intensity.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bruxism
Time Frame: 1 day
|
it is determined on physical examination based on the presence of abnormal tooth wear, tooth marks in the buccal region, tooth marks on the tongue, and hypertrophy of the masseter muscle.
|
1 day
|
the presence of bruxism, tinnitus and dizzeness
Time Frame: 1 day
|
the presence of bruxism, tinnitus and dizzeness
|
1 day
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Vestibular Diseases
- Sensation Disorders
- Jaw Diseases
- Hearing Disorders
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Joint Diseases
- Vertigo
- Dizziness
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Tinnitus
Other Study ID Numbers
- KAEK/2022.03.55
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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