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88 contralateral (opposite) side will not be treated and serve as control for comparison purpose. If after 90 days of treatment the study orthodontist/dentist deems it desirable, treatment with the LED device on the contralateral (opposite) side may occur for a further 90 days to balance the bilateral mechanics. IT IS CRITICAL FOR THE OUTCOME OF THIS STUDY AND YOUR OWN SAFETY THAT YOU ADHERE TO THE TREATMENT SCHEDULE THAT YOUR STUDY ORTHODONTIST/DENTIST HAS IDENTIFIED FOR YOU. Potential harms / risks / benefits Although this LED therapy has been researched in the medical literature with respect to healing wounds, increased blood circulation and stimulation of soft tissue and bone growth, the Biolux LED device is an experimental device that has not yet been approved by Health Canada for use outside of research studies like this one. Some known limited risks, although rare, are associated with placing the LED source on the surface of the skin. These risks and discomforts may include: • Skin allergic reaction (such as hives, swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing and, if not treated promptly, could become life-threatening) due to contact with the device or its components. The types of plastic materials that may come into contact with the skin include polyurethane, polycarbonate, neoprene, nylon and styrene-butadiene. No latex is included in the Biolux LED device. • If you are, or will be, using any medication, herbal or “natural” remedy, during the course of this study, please inform your study orthodontist/dentist immediately. Please checkPDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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