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IRCT20130812014333N180 IRCT 2022-02-08 Kermanshah University of Medical Sciences Effect of different photobiomodulation laser therapy in orthodontic pain reduction Effect of different photobiomodulation laser therapy in orthodontic pain reduction caused by elastic separator: randomized control trial 2022-03-01 anticipated 24 Complete https://irct.ir/trial/61668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Generate random numbers using online software. Divided quadrants will be drawn on 24 sheets of paper (in the number of patients) and random numbers will be written on each quadrant. Then, each of the papers will be placed in an envelope. Each patient removes an envelope and based on that, the method of placement of elastic seperator will be done in each quadrant. The production of random numbers and allocation concealment will be done by an impartial observer, Blinding description: Laser light with a wavelength of 940 nm is not visible to the human eye and no heat is generated. Therefore, both the patient and the operator were blind (on or off) when using the laser. The laser radiation will be performed by the dentist's assistant. The operator will not know which quadrant is treated with the laser on and which is treated with the laser off. However, complete blinding of the patient will not be possible, and only blinding for laser on or off will be possible. N/A Orthodontic Pain. Intervention 1: In the first intervention group, a laser quadrant unit is turned on; Apply the laser for the first quarter of 120 seconds (60 seconds for each buccal or lumbar). At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied. Intervention 2: In the second intervention group, 60 seconds lingual or palatal, and we reduce the time by half (that is, 30 seconds for each groceries). At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied. Intervention 3: In the third intervention group, a silent laser is used. At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied. Intervention 4: Laser is not performed in the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Amin Golshah
Faculty of Dentistry, Shariati Ave
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 amin.golshah@gmail.com Kermanshah University of Medical Sciences scientific Dr Amin Golshah
Faculty of Dentistry, Shariati Ave
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 amin.golshah@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age 18 to 30 years In both jaws, all teeth are fully erupted by the second molar before treatment, and the second premolars, first and second molars are in contact, allowing to put 2 elastic separators in the mesial and distal of the first four molars. 18 years 30 years Both Dependence on psychotropic drugs History of taking anticonvulsants and antidepressants History of chronic systemic diseases such as liver, lung, heart and kidney diseases, etc. History of neuropathic disorders, glossopharyngeal neuralgia, etc.). Diabetes and metabolic diseases Infectious diseases, autoimmune diseases, immune defects, AIDS Pregnancy Symptoms of infection or periodontal disease History of tooth extraction from 2 weeks ago Z51.8 Encounter for other specified aftercare Treatment - Other Treatment - Other Treatment - Other Other In the first intervention group, a laser quadrant unit is turned on; Apply the laser for the first quarter of 120 seconds (60 seconds for each buccal or lumbar). At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied. In the second intervention group, 60 seconds lingual or palatal, and we reduce the time by half (that is, 30 seconds for each groceries). At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied. In the third intervention group, a silent laser is used. At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied. Laser is not performed in the control group. Pain. Timepoint: 0, 1, 6, 12, 24, 48 hours after Separator placement. Method of measurement: Using Visual Analogue Scale. Kermanshah University of Medical Sciences Approved 2022-01-10 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)