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IRCT20120220009086N4 IRCT 2019-06-01 Hamedan University of Medical Sciences Investigating the effect of intra-oral LED device and low level laser therapy on the rate of orthodontic maxillary canine movement compared with control group: a randomized clinical trial Investigating the effect of intra-oral LED device and low level laser therapy on the rate of orthodontic maxillary canine movement compared with control group: a randomized clinical trial 2019-06-10 anticipated 60 Complete https://irct.ir/trial/38327 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into 4 classes (gender-based and bracket-based) randomized block randomization methods. The size of the blocks is variable and is determined by the software. This randomization is coordinated by an individual outside the research team in all cases, Blinding description: Patients are blinded to intervention. Patients in the control group use a light-curing device with a protective coating in place of radiation, and radiation is done on days 0, 3, 30, and 60 according to the laser protocol. In this research, the person who collects the data, as well as the statistical advisor, are not aware of the allocation of groups, LED lasers and controls. N/A Anomalies of tooth position of fully erupted teeth. Intervention 1: Intervention group1: Laser therapy is performed using the China Gigaa laser machine (dental diode laser Gigaa). The laser used is Ga Al As laser with a wavelength of 810 nm and a power of 100 μW. Diameter of laser tip in contact with tissue is 3.1 mm. Energy density is 4 Jules per square centimeter. Therapy is performed on days 0 and 3 and then on the day of spring activation (monthly) for 4 months (days 0, 3, 30 and 60) for 2 months. The laser is projected to 3 points at the buccal surface of the canine teeth, a point in the cervical, one point in the apical region, and one point in the middle region of root, at each point for 3 seconds. Similarly, 3 regions on the palatal surface of the canine also will be be irradiated. Intervention 2: Intervention group2: The patients are trained in this group and they are advised to use the biolight device for 5 minutes everyday for two months. This intra-oral LED device is made up of 640 nm wavelength and 20 mw / cm2 power diodes. The device consists of 2 pairs of LEDs on the right or left that are located in the canine area of the tooth space. Intervention 3: Control group: For patients in the control group, a similar light device with a protective coating is used , and radiation is performed on days 0, 3, 30 and 60 according to the laser protocol. Yes - There is a plan to make this available What will be shared: laser versus LED light groups rate of tooth movement data set all collected deidentified IPD are to be shared When: starting 6 months after publication, the data will be available for 20 years To whom: the data will be available only for people working in academic institutions Conditions: no types of analyses on the documents is allowed Where to obtain: the preferred way of communication is via email mozhde.borjali@yahoo.com the postal address is, Hamadan dental school, in front of Mardom park, Shahid Fahmideh street, Hamadan telephone number is +98 81 3838 1059 fax number is +98 81 3838 1085 the contact person is Mozhde Borjali How to obtain: the requests will be discussed and the data would be available in three months Comments:
public Mozhde Borjali
in front of Mardom park, Shahid Fahmideh street, Hamadan
Hamadan Iran (Islamic Republic of) 6517838741 +98 81 3838 1059 mozhde.borjali@yahoo.com Hamedan University of Medical Sciences scientific Mozhde Borjali
in front of Mardom park, Shahid Fahmideh street, Hamadan
Hamadan Iran (Islamic Republic of) 6517838741 +98 81 3838 1059 mozhde.borjali@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) orthodontic treatment plan that needs extraction of maxillary first premolar unilaterally or bilaterally presence of maxillary canine, second premolar and first molar at the side of extraction of first premolar 15 years 25 years Both canine root dilaceration long-term consuming nonsteroidal anti inflammatory drugs a and hormonal supplements parafunctional habits crossbite in canine area poor periodontal health pregnancy and lactating history of previous fixed orthodontic treatment M26.3 Anomalies of tooth position of fully erupted tooth or teeth Treatment - Devices Treatment - Devices Placebo Intervention group1: Laser therapy is performed using the China Gigaa laser machine (dental diode laser Gigaa). The laser used is Ga Al As laser with a wavelength of 810 nm and a power of 100 μW. Diameter of laser tip in contact with tissue is 3.1 mm. Energy density is 4 Jules per square centimeter. Therapy is performed on days 0 and 3 and then on the day of spring activation (monthly) for 4 months (days 0, 3, 30 and 60) for 2 months. The laser is projected to 3 points at the buccal surface of the canine teeth, a point in the cervical, one point in the apical region, and one point in the middle region of root, at each point for 3 seconds. Similarly, 3 regions on the palatal surface of the canine also will be be irradiated. Intervention group2: The patients are trained in this group and they are advised to use the biolight device for 5 minutes everyday for two months. This intra-oral LED device is made up of 640 nm wavelength and 20 mw / cm2 power diodes. The device consists of 2 pairs of LEDs on the right or left that are located in the canine area of the tooth space. Control group: For patients in the control group, a similar light device with a protective coating is used , and radiation is performed on days 0, 3, 30 and 60 according to the laser protocol. Rate of tooth movement. Timepoint: at start of study, 1,2 and 3 months after intervention. Method of measurement: 3D scanner and software. Pain. Timepoint: two weeks after intervention. Method of measurement: modified McGill questionair. Rotation of the canine. Timepoint: at start of study, 1,2 and 3 months after intervention. Method of measurement: 3D scanner and software. Hamedan University of Medical Sciences Approved 2019-05-06 Ethics committee of Hamadan University of Medical Sciences in front of Mardom park, Shahid Fahmideh street, Hamadan hamadan Hamadan Iran (Islamic Republic of)