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IRCT20210514051292N1 IRCT 2022-05-11 Birjand University of Medical Sciences Investigating the effect of laser in orthodontics Comparing low level laser therapy and laser acupuncture effects on reducing pain in orthodontic patients 2022-04-21 anticipated 45 Complete https://irct.ir/trial/62702 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with the above conditions were divided into three groups randomly and by blocking method (blocks of size 3) into one of three groups: intervention 1 and intervention 2 or control. Patients were divided into three groups: Simpler2 diode laser as group A, Wiser 3 laser diode as group B and control group as group C. First, various blocks of size 3 were created (ABC, ACB, BAC, BCA, CAB, CBA). One of these blocks was randomly selected and divided into one of three groups A, B or C according to the order mentioned in the patients' selected block. Then randomization was performed for other patients, Blinding description: This study is single-blinded in which patients are unaware that they are receiving laser therapy or placebo. In both treatment groups and placebo, the laser is placed in the same way and with the same specifications in the desired points, and the light and sound of the laser beep are on for both groups, but the radiation is done only for the treatment group. N/A Pain in orthodontics. Intervention 1: Intervention group 1: For patients in this group, a Simpler2 diode laser (Doctor Smile Simpler, made in Italy) with a wavelength of 980 nm with a biomodeling handpiece will be used with the following parameters: 1 watt output energy, 1 cm square cross-sectional area, continuous mode ), Dose 150 joules per square centimeter, time 150 seconds in total. The laser diode will be in contact with the soft tissue. Intervention 2: Intervention group 2: For patients in this group, a Wiser 3 diode laser (Doctor Smile, made in Italy) with a wavelength of 808 nm with a biomodeling handpiece with the following parameters will be used: 200 mW output energy, 0.28 cm cm cross-sectional area, continuous mode continuous), energy dose 21 joules per square centimeter, time 30 seconds at each point, 8 points (points sl18-st6-st7-li4 on both sides), total time 4 minutes. The diode laser will be used in contact with the tissue. Intervention 3: Control group: For this group, the device is kept in the same position as the previous groups for patients, but no treatment is provided. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no need.
public Behzad Ghadiri
No. 88, Saeedi 12 Ave, West Saeedi street, Modares Blvd, Birjand
birjand Iran (Islamic Republic of) 9713784168 +98 912 142 5303 behzad.ghadiri.14@gmail.com Birjand University of Medical Sciences scientific Behzad ghadiri
No. 88, Saeedi 12 Ave, West Saeedi street, Modares Blvd, Birjand
Birjand Iran (Islamic Republic of) 9713784168 +98 912 142 5303 behzad.ghadiri.14@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Patients that are treated for the first time using a fixed orthodontic appliance. Having no systemic diseases. Having fully erupted permanent teeth. Having no chronic or neural pain. 18 years 40 years Both Patients who are pregnant. Patients who use systemic medications (analgesics, antibiotics, anti-inflammatory drugs, antidepressants, and bisphosphonates). Patients with pathological conditions associated with teeth, gingiva, or periodontium. G89 Pain, not elsewhere classified Treatment - Other Treatment - Other Placebo Intervention group 1: For patients in this group, a Simpler2 diode laser (Doctor Smile Simpler, made in Italy) with a wavelength of 980 nm with a biomodeling handpiece will be used with the following parameters: 1 watt output energy, 1 cm square cross-sectional area, continuous mode ), Dose 150 joules per square centimeter, time 150 seconds in total. The laser diode will be in contact with the soft tissue. Intervention group 2: For patients in this group, a Wiser 3 diode laser (Doctor Smile, made in Italy) with a wavelength of 808 nm with a biomodeling handpiece with the following parameters will be used: 200 mW output energy, 0.28 cm cm cross-sectional area, continuous mode continuous), energy dose 21 joules per square centimeter, time 30 seconds at each point, 8 points (points sl18-st6-st7-li4 on both sides), total time 4 minutes. The diode laser will be used in contact with the tissue. Control group: For this group, the device is kept in the same position as the previous groups for patients, but no treatment is provided. Pain score. Timepoint: Immediately, 6 hours, 12 hours, 1 day, 2 days, 3 days, 4 days and 5 days after orthodontic applique placement. Method of measurement: Visual Analogue Scale. Birjand University of Medical Sciences Approved 2021-10-09 Ethics committee of Birjand University of Medical Sciences Birjand University of Medical Sciences, Moalem street, Birjand Birjand South Khorasan Iran (Islamic Republic of)