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IRCT20211010052719N1 IRCT 2021-10-26 Shahid Beheshti University of Medical Sciences Investigation of the effects of three conservative treatment methods on temporomandibular disorders Investigation of the effects of three conservative treatment methods on temporomandibular disorders 2020-09-10 anticipated 30 Complete https://irct.ir/trial/59463 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly allocated to 3 treatment groups. A central randomization unit was contacted by phone to ensure allocation concealment and assign the enrolled patient to each treatment group. The central randomization unit had prepared a list of numbers from 1 to 30 that were allocated randomly to 3 equal groups using a website (https://www.random.org.) which generated a list of random numbers in 3 columns. Before randomization, the first column was considered the Stabilization splint treatment group, the second column the low level laser treatment group, and the third column the combination treatment group (low level laser + Stabilization splint). N/A Temporomandibular disorders. Intervention 1: Stabilization splint treatment group: Splints are made according to Okeson's instructions and necessary adjustments are made. The patient is instructed to use the splint for 12 hours a day for three months. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment. Intervention 2: Low level Laser treatment group: A diode laser device, noncontact mode, continuous wave, 0.1 W (100 mW), 810 nm, 6 J / cm, 2,60 s / session are used, which is performed in three sessions per week for three weeks ( A total of nine sessions). The laser is applied to the origin, insertion, and body areas of the masseter muscle and the anterior, middle, and posterior parts of the temporalis muscle , as well as to the center of the upper joint space, about one cm in front of the tragus. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment. Intervention 3: Combination treatment group: This group of treatments is initially treated with low level laser according to the mentioned protocol. Then, immediately after the end of the laser treatment, they are treated with a splint according to the protocol for three months. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Data will be analyzed and presented in the final report of the results such as articles as tables and figures.
public Zahra Afshari
Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 19839-63113 +98 31 5366 4431 afsharyzhr1@gmail.com Shahid Beheshti University of Medical Sciences scientific Zahra Afshari
Daneshjoo Blvd, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 19839-63113 +98 31 5366 4431 afsharyzhr1@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Chronic orofacial pain (more than three months) with or without restriction in opening the mouth. Diagnosis of Temporomandibular disorder (Axis I) based on the RDC / TMD diagnostic criteria. History of no previous treatment for TMD during the last month. Having natural dentition 18 years 60 years Both Recent fracture of mandibular bone. History of recent facial trauma Congenital / developmental disorders of the jaw. Systemic musculoskeletal disease. Fibromyalgia. Previous or current history of the cancer. Skin lesions at the laser site. Pregnancy. Diagnosis of Temporomandibular disorder of articular origin based on the RDC / TMD diagnostic criteria. M26.6 Temporomandibular joint disorders Treatment - Devices Treatment - Devices Treatment - Devices Stabilization splint treatment group: Splints are made according to Okeson's instructions and necessary adjustments are made. The patient is instructed to use the splint for 12 hours a day for three months. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment. Low level Laser treatment group: A diode laser device, noncontact mode, continuous wave, 0.1 W (100 mW), 810 nm, 6 J / cm, 2,60 s / session are used, which is performed in three sessions per week for three weeks ( A total of nine sessions). The laser is applied to the origin, insertion, and body areas of the masseter muscle and the anterior, middle, and posterior parts of the temporalis muscle , as well as to the center of the upper joint space, about one cm in front of the tragus. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment. Combination treatment group: This group of treatments is initially treated with low level laser according to the mentioned protocol. Then, immediately after the end of the laser treatment, they are treated with a splint according to the protocol for three months. The outcomes are evaluated at intervals before splint treatment, one month, three months, after the start of treatment. Pain intensity. Timepoint: Before treatment, immediately after treatment, one month and three months after the end of treatment. Method of measurement: visual scale analogue (VAS). Maximum mouth opening with NO assistance. Timepoint: Before treatment, immediately after treatment, one month and three months after the end of treatment. Method of measurement: By ruler in millimeters. Right & left and anterior lateral movement of mandible. Timepoint: Before treatment, immediately after treatment, one month and three months after the end of treatment. Method of measurement: By ruler in millimeters. Functional limitations of jaw. Timepoint: Before treatment, immediately after treatment, one month and three months after the end of treatment. Method of measurement: visual scale analogue (VAS). Shahid Beheshti University of Medical Sciences Approved 2020-09-09 the Ethics Committee of Shahid Beheshti University of Medical Sciences Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)