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IRCT20230812059121N1 IRCT 2023-09-18 Semnan University of Medical Sciences Investigating the effect of laser acupuncture on the quality of life of patients with temporomandibular disorders Investigating the quality of life and pain and maximum mouth opening in patients with temporomandibular disorders referring to the jaw and face pain clinic of Semnan Faculty of Dentistry with the complementary treatment of laser acupuncture. 2023-08-14 anticipated 20 Complete https://irct.ir/trial/71961 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first stage, patients are included in the study by meeting the criteria for entering the study. Therefore, our sampling method is easy at this stage. In the second stage, they are divided into two groups A and B using the block randomization method. Then, in the third step, using the table of random numbers, we determine which group will receive treatment and which group will receive placebo, Blinding description: The patients are informed that this plan is a study and includes two treatment and control groups, but they do not know about their group, and a dental student measures the variables of the study before and after the treatment, who is blind to the groupings. The executive officer of the plan informs the physiotherapist about the groups to use the laser for the treatment group and the guiding light of the device for the control group. N/A temporomandibular disorders. Intervention 1: Intervention group: Laser therapy with LUMIX 2 HFPL low power diode laser machine made in Italy with wavelength nm810, output power mw500 and energy density j/cm2 21, frequency 13 kHz, output energy J 16.4 and modulation 100% with continuous waveform for 3 minutes. It takes 30 minutes for each acupuncture point, for a total of 10 points. The points under treatment include: GB20, SI19, ST6, ST7, LI4, which will be treated bilaterally. Both groups visit twice a week for a total of 10 sessions. Intervention 2: Control group: Only the guiding light of the device will be used as laser acupuncture in the same areas and with the same frequency and time as the first group. Yes - There is a plan to make this available What will be shared: Information on the main outcome is shared When: شروع دوره دسترسی 4ماه پس از چاپ نتایج To whom: محققین شاغل در موسسات دانشگاهی و علمی Conditions: It can be used by mentioning the source Where to obtain: Maryam Shiransab with email address:shirin1998f@gmail.com How to obtain: Accept the request until 2 months later Comments:
public Rasool Bagheri
hefdah shahrivar
semnan Iran (Islamic Republic of) 35187-94431 +98 910 073 7438 Rasool.bagheri@ymail.com Semnan University of Medical Sciences scientific Nahid Karbasi
Hefdeh Shahrivar Street
semnan Iran (Islamic Republic of) 3518794431 +98 913 397 8074 sov.karbasi@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with a history of pain with VAS≥4 in masticatory muscles and/or temporomandibular joint during jaw movements or function (TMD muscle disorders (Class Ia, Ib) or anterior displacement of the disc with or without return (Class IIa, IIb) or arthralgia ( Class IIIa) based on (RDC/TMD) Limitations in jaw movements (mouth opening < 40 mm or side movements < 8 mm) Jaw sound while opening and closing the mouth Deviation during opening and closing the mouth no limit no limit Both Patients with a history of acute trauma Patients who have been treated for temporomandibular joint disorders in the last month Any pain with other origins such as decayed teeth, impacted teeth, other pathological lesions or neurological disorders in the head and neck area People with congenital and neoplastic diseases in the TMJ range People with joint diseases such as osteoarthritis and rheumatoid arthritis or suffering from hypermobility syndrome Uncontrolled systemic problems with disability (ASA II or higher) including diabetes, thyroid disease, kidney disease, epilepsy and people with cerebrovascular problems People with bleeding diseases or users of anticoagulants Users of corticosteroid drugs Cardiac patients or those with a pacemaker Pregnant or breastfeeding mothers Patients with psychiatric disorders such as severe depression and psychosis Patients with any severe orthognathic deformities Patients with posterior edentulousness M26.60 Temporomandibular joint disorder, unspecified Treatment - Devices Treatment - Devices Intervention group: Laser therapy with LUMIX 2 HFPL low power diode laser machine made in Italy with wavelength nm810, output power mw500 and energy density j/cm2 21, frequency 13 kHz, output energy J 16.4 and modulation 100% with continuous waveform for 3 minutes. It takes 30 minutes for each acupuncture point, for a total of 10 points. The points under treatment include: GB20, SI19, ST6, ST7, LI4, which will be treated bilaterally. Both groups visit twice a week for a total of 10 sessions. Control group: Only the guiding light of the device will be used as laser acupuncture in the same areas and with the same frequency and time as the first group. Quality of life. Timepoint: The beginning and end of the study and One month after the last treatment session. Method of measurement: questionnaire. Maximum mouth opening. Timepoint: The beginning and end of the study and One month after the last treatment session. Method of measurement: Ruler with millimeter division. Pain. Timepoint: The beginning and end of the study and One month after the last treatment session. Method of measurement: Visual Analogue Scale. Faculty of Physiotherapy Approved 2023-08-17 Semnan University of Medical Sciences dental clinic،hefdah shahrivar Blvd semnan Semnan Iran (Islamic Republic of)