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87 This study and the use of the prototype Biolux LED device have received Investigational testing authorization from Health Canada. At this time the Biolux LED device is not available for use outside of research studies. The information in this form is intended to help you understand exactly what we are asking of you, so that you can decide whether or not you want to participate in this study. Please read this consent form and the BIOLUX User Guide for Patients carefully and ask all the questions you might have before deciding whether or not to participate in this study. Your participation in this study is entirely voluntary and a decision not to participate will not in any way affect any future treatment. Why is the study being done? The purpose of the study is to evaluate the effectiveness of a LED phototherapy on the rate of OTM. The LED device is thought to provide light energy to bone tissue cells which absorb the light energy and convert to chemical energy. This energy is subsequently used in bone regeneration and growth. Traditional orthodontic treatment with appliances typically takes 12 to 36 months and LED phototherapy may shorten this treatment period, to the benefit of the patient. This study is intended to include that participation of approximately 40 patients in a University of Toronto Faculty of Dentistry Graduate Orthodontic clinic. What will you be asked to do? Your LED device will be programmed in accordance with the specific therapy that best applies to your condition. Subsequently, you will be shown how to wear the headset, how to connect the various components, and how to power on and off the device. More detailed information about the use of the LED device is contained in the BIOLUX User Guide for Patients document. Finally, your study orthodontist/dentist will define with you a schedule for your specific therapy program, including planned follow-up visits (typically at 2 six week internals), where the study orthodontist/dentist will take records to measure tooth positioning and also adjust the orthodontic appliances as per the regular planned orthodontic treatment. Each visit to the study orthodontist/dentist is typically 1 hour long. The entire study duration is expected to be 90 days. Treatment with the LED device will be carried out on one quadrant of your mouth, while thePDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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