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IRCT20190610043853N1 IRCT 2020-01-14 Tehran University of Medical Sciences Evaluation Of the effect of Low-level laser therapy on pain Evaluation of the effect of low-level laser therapy on pain control caused by Elastomeric Separators in Orthodontic patients 2019-07-22 anticipated 25 Complete https://irct.ir/trial/40258 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples were randomly allocated to the study groups by using block random method (blocks of size 4) using in Excel software. The last two samples were assigned to the study groups by simple randomization method, Blinding description: In this study, the patient and the observer (data collector) are not informed about which study groups they are placed in. In regards to blinding, the patient in the non-radiation group receives a palcebo light, which is not a laser type and can be a light cure device. The person who does data analysis is not involved in the intervention procedure. N/A pain. Intervention 1: Intervention group: laser radiation in one quadrant of mouth The study is Split-mouth design so the intervention group and the control group are both in the same person. One side of patient (one half jaw) is as the intervention group and the other half as the control group which receiving placebo radiation. 24 hours before placing separators on the upper first molar, the first dose of low power 810 nm diode laser with a power of 0.3 W and energy of 3.75 J / cm2 and spot area = 0.8 cm2 and a continuous 10 seconds will be radiated on the location of radiation. The second radiation will be done at the time of placement and the third dose in 24 hours after the separators are placed. The patient's pain will be measured using the VAS method based on self-perception at 0, 2, 6, 24, 72 hours and 5 days after placement of separators, and recorded the data and the amount of pain between the two groups are compared. Intervention 2: Control group: non-radiation laser in opposite side of the same jaw in the same person. The control group receives an inactive radiation as placebo at times like the intervention group. The method of measuring pain is as same as intervention group. Yes - There is a plan to make this available What will be shared: All data is received after the receipt of the article resulting from the study can be shared When: Access 4 months after the publication of the paper resulting from the research To whom: Researchers working in academic and academic institutions Conditions: All analyzes that do not need to identify samples and re-access them to data can be done Where to obtain: Refer to the author of the article How to obtain: Perform correspondence with the submitter and send the information file Comments:
public Seyed Amirhossein Mirhashemi
Tehran University of Medical Sciences, Faculty of Dentistry, Not reaching the Hakim highway, above the Atomic Energy Organization, End of the North Amirabad St, Kargar Ave.
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5950 mirhashemi@tums.ac.ir Tehran University of Medical Sciences scientific Seyed Amirhossein Mirhashemi
Tehran University of Medical Sciences, Faculty of Dentistry, Not reaching the Hakim highway, above the Atomic Energy Organization, End of the North Amirabad St, Kargar Ave.
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5950 mirhashemi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Twenty-five volunteer patients who are eligible for orthodontic treatment Both male and female Age between 18 and 30 years old 18 years 30 years Both Having specific Systemic disease Having specific Mental problem Having specific Dental or Periodontal problem Using specific Medication R52 Pain, not elsewhere classified Prevention Prevention Intervention group: laser radiation in one quadrant of mouth The study is Split-mouth design so the intervention group and the control group are both in the same person. One side of patient (one half jaw) is as the intervention group and the other half as the control group which receiving placebo radiation. 24 hours before placing separators on the upper first molar, the first dose of low power 810 nm diode laser with a power of 0.3 W and energy of 3.75 J / cm2 and spot area = 0.8 cm2 and a continuous 10 seconds will be radiated on the location of radiation. The second radiation will be done at the time of placement and the third dose in 24 hours after the separators are placed. The patient's pain will be measured using the VAS method based on self-perception at 0, 2, 6, 24, 72 hours and 5 days after placement of separators, and recorded the data and the amount of pain between the two groups are compared. Control group: non-radiation laser in opposite side of the same jaw in the same person. The control group receives an inactive radiation as placebo at times like the intervention group. The method of measuring pain is as same as intervention group. Pain. Timepoint: 0hours, 2 hours, 6hours, 24hours, 72hours and 5 days after laser. Method of measurement: visual analogue scale. Tehran University of Medical Sciences Approved 2019-01-28 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Faculty of Dentistry, Not reaching the Hakim highway, above the Atomic Energy Organization, End of the North Amirabad St, Kargar Ave. Tehran Tehran Iran (Islamic Republic of)