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IRCT20221018056237N1 IRCT 2022-11-02 Islamic Azad University The effect of low level laser therapy in fixed orthodontic treatment The effect of low level laser therapy at canine movement in fixed orthodontic treatment among adult 2022-11-22 anticipated 15 Complete https://irct.ir/trial/66416 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: split mouth design, Randomization description: The design of the study is split mouth and the side of the intervention ( laser radiation) and control side ( placebo ) in the mouth will be determined by simple randomization .The random sequence will be carried out by an independent person by flipping the coin .The side of the radiation and the non - radiation for each patient will be placed in a letter and will be opened directly before the laser irradiation starts , Blinding description: The participants ( patients ) are completely unaware which side, laser will be radiated and which side is placebo. N/A Low level laser therapy and canine movement during fixed orthodontic treatment. Intervention 1: Intervention group: After alignment of teeth, in retraction phase, at intervention side, irradiation of GA-AL-AS diode laser (Ilase, USA) will be done with 3 weeks intervals ( for 9weeks). Laser will operate at 940 nm wavelength in a continuous mode. Irradiation will deliver through the 0.04 cm2 diameter optical fiber tip in light contact with the oral mucosa.( 5 points at buccal and 5 points at palatal). The target area will irradiate on these sites, for 3seconds in each point. ( Mesial and distal to the cervical area of the canine, Mesial and distal to the apical area of the canine, One point in the middle of the root). The power output set at 100 mW for 3 sec at each point made the cumulative of 7.5 J/cm2 energy density. Intervention 2: Control group: After alignment phase laser will not irradiate at placebo side and just red marker of laser will be on. Yes - There is a plan to make this available What will be shared: The total data will be shared. (all collected unidentified IPD) When: Access will start from 2023 . To whom: For researchers who working at academic institutions. Conditions: In order to use in the scientific research, data can be used. Where to obtain: Fatemeh shirini 00989351513752 aisashirini@gmail.com How to obtain: After submitting the request, it will be answered at the earliest possible time. Comments:
public Fatemeh Shirini
No1, west 16th, South Vahid Ave, Sazman barnameh Ave, Hejazi Blv, Tehran, Iran
Tehran Iran (Islamic Republic of) 1484986517 +98 21 4411 0127 aisashirini@gmail.com Islamic Azad University scientific Fatemeh Shirini
No1, west 16th, South Vahid Ave, Sazman barnameh Ave, Hejazi Blv, Tehran, Iran
Tehran Iran (Islamic Republic of) 1484986517 +98 21 4411 0127 aisashirini@gmail.com Islamic Azad University Iran (Islamic Republic of) Patient should be older than 18 years Patient should have all permanent teeth (except third molar) There should be a possibility of placing brackets to all of the maxillary teeth Requiring extraction of premolars bilaterally in the maxillary arch Patient should have good oral hygiene 18 years no limit Both History of orthodontic treatment Presence of systemic disease Severe dental displacement Treatment - Devices Treatment - Devices Intervention group: After alignment of teeth, in retraction phase, at intervention side, irradiation of GA-AL-AS diode laser (Ilase, USA) will be done with 3 weeks intervals ( for 9weeks). Laser will operate at 940 nm wavelength in a continuous mode. Irradiation will deliver through the 0.04 cm2 diameter optical fiber tip in light contact with the oral mucosa.( 5 points at buccal and 5 points at palatal). The target area will irradiate on these sites, for 3seconds in each point. ( Mesial and distal to the cervical area of the canine, Mesial and distal to the apical area of the canine, One point in the middle of the root). The power output set at 100 mW for 3 sec at each point made the cumulative of 7.5 J/cm2 energy density. Control group: After alignment phase laser will not irradiate at placebo side and just red marker of laser will be on. Rate of canine movement. Timepoint: T0 (before laser therapy), after 6weeks, after 9weeks, after 12 weeks. Method of measurement: Intra oral scanner. Islamic Azad University Approved 2022-10-03 Ethics committee of the Dental branch of Tehran Azad Islamic University No9, Dental branch of Islamic Azad University, 9th Neyestan, Pasdaran Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)