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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04708938
Other study ID # 68869993-511.06-E.239934
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date December 1, 2021

Study information

Verified date May 2022
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to examine the effect of high voltage electrical stimulation on pain, temporomandibular joint mobility, cervical mobility, head position, tender points and joint sounds in individuals with temporomandibular disorders.


Description:

28 individuals who meet the TMER / Research Diagnostic Criteria classification will be randomly divided into 2 groups. Exercise with high voltage electrical stimulation (YVES) will be applied to the 1st group and only exercise will be applied to the 2nd group. The second group will be the control group of the study. Both groups will be informed about the disease before starting the study before the treatment and patient education will be given about the situations that need attention. Again, 2 groups will be given an exercise program from the day they start the treatment, 3 times a week for 4 weeks during the treatment. As sociodemographic information of the individuals, age, gender, height, weight, body mass index, marital and educational status, occupation, smoking and alcohol use, patient history, family history and complaint sides will be recorded. Before starting treatment, individuals will be evaluated for pain, temporomandibular joint mobility, cervical mobility, tender points, and joint sounds: 1. Pain with Visual Analogue Scale (VAS), 2. TMJ mobility with a ruler, 3. Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer, 4. Head position with universal goniometer and ImageJ software, 5. Sensitive points with algometer, 6. Joint sounds will be evaluated as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion). After 4 weeks of treatment, the measurements will be repeated.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Individuals who have been diagnosed with TMER, - Comply with the TMD / RDC classification, - Have Class I-II-III occlusion, - Volunteer to participate in the study, and fill out the informed consent form will be included. Exclusion Criteria: - Acute trauma, - Surgery history, - Neurological or psychiatric conditions, - Trigeminal or postherpatic neuralgia, - Dental or orofacial infection, - Intraoral infection or tumor, - Oligodontics and anadontics, - High voltage electrical stimulation contraindications, - Any disease diagnosed in the shoulder and neck areas, - Receiving another treatment and, - Individuals under the age of 18 will be excluded in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High voltage electrical stimulation+exercise therapy
The effect of high voltage electrical stimulation on temporomandibular disorders
Exercise therapy
The effect of high voltage electrical stimulation on temporomandibular disorders

Locations

Country Name City State
Turkey Gazi University, Faculty of Health Sciences Ankara None Selected

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain on temporomandibular joint Pain with Visual Analogue Scale (VAS) Before and after treatment, 4 weeks apart. It takes 10 seconds.
Primary Change in temporomandibular joint mobility Temporomandibular joint mobility with a ruler Before and after treatment, 4 weeks apart. It takes 3 minutes.
Primary Change in cervical mobility Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer Before and after treatment, 4 weeks apart. It takes 5 minutes.
Primary Change in head position Head position with universal goniometer and ImageJ software Before and after treatment, 4 weeks apart. It takes 3 minutes.
Primary Change in tender points Tender points with algometer Before and after treatment, 4 weeks apart. It takes 10 minutes.
Primary Change in joint sounds Joint sounds as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion) Before and after treatment, 4 weeks apart. It takes 2 minutes.
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