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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05402228
Other study ID # KAEK/2022.03.55
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 27, 2022
Est. completion date June 15, 2022

Study information

Verified date July 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 15, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
temporomandbular joint disorders
no intervention

Locations

Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Kucukcekmece
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Kucukcekmece

Sponsors (2)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximum mouth opening maximum mouth opening 1 day
Primary right and left lateral movement, deflexion, and deviation right and left lateral movement, deflexion, and deviation 1 day
Primary TMJ sound the TMJis palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh was noted. 1 day
Primary visual analog scale It is use for evaluate the pain intensity. 1 day
Secondary bruxism 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
Secondary the presence of bruxism, tinnitus and dizzeness the presence of bruxism, tinnitus and dizzeness 1 day
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