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37 variability that a larger sample size would be intended to overcome and was within the sample size range needed for detection of a clinically relevant difference between groups. This study relied on the benefits of the split-mouth design that permits intra-patient comparison. As opposed to inter-patient comparisons, intra-patient comparisons require much smaller sample sizes since each individual acts as his/her own control. Therefore, differences in rates of OTM between patients due to different biological conditions (e.g., differences in bone density and bone metabolism) or orthodontic appliances and biomechanics are reduced, if not eliminated. In essence, since all parameters are the same on both side of the mouth and the intervention is delivered to only half of the dental arch, this permits the evaluation of the clinical effects of the IR-LED phototherapy. There are 2 major challenges to the validity of the split- mouth design: A) the possibility that there might be a systemic effect from the LED phototherapy; and B) the possibility of photoleakage to the contralateral side of the dental arch. A) The split-mouth design and the possibility of a systemic effect of LED phototherapy It is expected that the greatest effects of the LED would to be at the site of LED administration. This assumption is based on the concept of the Basic Multicellular Unit of bone remodelling, where there is compartmentalization and the creation of a local vascular environment for bone remodelling (Eriksen, 2010). The basic mechanisms of bone remodelling between a targeted situation (e.g. application of a orthodontic force) versus resting state also differ. The regulation of non-targeted bone remodelling occurs through the activities of hormones like parathyroid hormone, thyroxine, growth hormone and estrogen whereas the mechanisms of localized bone remodelling are thought to involve osteocytes and RANKL (Eriksen, 2010; Boyce and Xing, 2008). In contrast, in a targeted situation osteocytes mechano-PDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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