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IRCT20211020052823N1 IRCT 2021-12-22 Shahid Beheshti University of Medical Sciences Comparative Effectiveness of Transcutaneous Electrical Nerve Stimulation, Low Level Laser Therapy and Occlusal Splint in the Treatment of Muscular TMJ Disorders Comparative Effectiveness of Transcutaneous Electrical Nerve Stimulation, Low Level Laser Therapy and Occlusal Splint in the Treatment of Muscular TMJ Disorders 2021-11-11 anticipated 30 Complete https://irct.ir/trial/59465 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients assign to 3 treatment groups through randomized block design. Subjects will be divided into 5 blocks of 6 patients for a total of 30 patients. In each block patients are randomly assigned to a specific treatment in Excel. So, in this randomized block design patients will receive random treatment based on their arrival. N/A Temporomandibular Joint (TMJ) Disorders. Intervention 1: Control group: Occlusal Splint Group (using for 3 months over night). Intervention 2: Intervention group: Low Level Laser Therapy- 8 sessions- on the 18 spots on Temporalis and Masseter Muscle bilaterally. Intervention 3: Intervention group: Transcutaneous Electrical Nerve Stimulation (TENS)- 8 sessions- apply on Temporalis and Masseter muscles. time: 20 min- frequency: 180 Hz- width: 45 us. Yes - There is a plan to make this available What will be shared: All patient's data including: Age, gender, treatment groups and treatment result are shareable. When: Simultaneous with published result To whom: Researchers of Academic Institutions Conditions: Quantitative Analysis Where to obtain: Nazieh Andollah Kookhi 00989183746219 nazikookhi@gmail.com How to obtain: Approximately one month after receiving email Comments:
public Majid Sedaghat Monfared
Daneshjou Blvd.
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 Majidsedaghatmonfared@gmail.com Shahid Beheshti University of Medical Sciences scientific Majid Sedaghat Monfared
Daneshjou Blvd.
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 majidsedaghatmonfared@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 1. Patient’s age between 20 to 60 years old 2- Chronic Myofascial Pain Disorder for more than 3 months 3- Diagnosis of Temporomandibular Disorder (base on RDC/TMD) 20 years 60 years Both Recent fracture of mandible bone History of recent trauma to the face Congenital disorder of jaws History of treatment for TMD in the past month Systemic disease of muscle Fibromyalgia History of Cancer Cutaneous lesion in the site that apply laser and tens Pregnancy History of Chemotherapy and Radiotherapy Psychological Disorder Dental and Oral Disease Wearing denture and Partial denture Treatment - Devices Treatment - Devices Treatment - Devices Control group: Occlusal Splint Group (using for 3 months over night) Intervention group: Low Level Laser Therapy- 8 sessions- on the 18 spots on Temporalis and Masseter Muscle bilaterally Intervention group: Transcutaneous Electrical Nerve Stimulation (TENS)- 8 sessions- apply on Temporalis and Masseter muscles. time: 20 min- frequency: 180 Hz- width: 45 us. The effect of treatment on Muscular Pain Level. Timepoint: Measuring the Muscular Pain Level at the beginning of the trail, just after treatment, one month, and 3 months after treatment. Method of measurement: Visual Analog Scale. Maximum Mouth Opening. Timepoint: Before intervention, just after treatment, 1 month and 3 months after treatment. Method of measurement: Millimeter. Right Lateral Movement of Mandible. Timepoint: Before intervention, just after, 1 month and 3 month after treatment. Method of measurement: Millimeters. Left Lateral Movement of Mandible. Timepoint: Before intervention, just after, 1 month and 3 months after treatment. Method of measurement: Millimeter. Protrusion. Timepoint: Before intervention, just after, 1 month and 3 months after treatment. Method of measurement: Millimeter. Pain during eating hard food. Timepoint: Before intervention, just after, 1 month and 3 months after treatment. Method of measurement: Visual Analog Scale. Pain during eating soft food. Timepoint: Before intervention, just after, 1 month and 3 months after treatment. Method of measurement: Visual Analog Scale. Pain during speaking. Timepoint: Before intervention, just after, 1 month and 3 months after treatment. Method of measurement: Visual Analog Scale. Pain during laughing. Timepoint: Before intervention, just after, 1 month and 3 months after treatment. Method of measurement: Visual Analog Scale. Pain during yawning. Timepoint: Before intervention, just after, 1 month and 3 months after treatment. Method of measurement: Visual Analog Scale. Shahid Beheshti University of Medical Sciences Approved 2020-09-08 Ethics Committee of Shahid Beheshti University of Medical Sciences Department of Prosthodontics, School of Dentistry, Shahid Beheshti University of Medical Science, Daneshjou Blvd, Velenjak St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)