Photobiomodulation LED Devices for Home Use: Design, Function and Potential: A Pilot Study.

Abstract

Background/Objectives: Many commercial light-emitting diode (LED) devices are available for consumer home usage. The performance characteristics in respect to the dosimetry of many of the devices, currently on direct sale to the public, have not been subject to formal appraisal. In order to 'bridge the gap' between the evidence-based photobiomodulation therapy (PBMT) community and other interested parties, an evaluation is made of a selection of torch type hand-held LED PBMT products currently available for home use. Methods: Five randomly chosen intra-oral and hand-held LED PBMT devices were selected. The optical delivery parameters of the devices were measured, including the beam divergence angle, surface area exposure as well as the output power at the level of the LEDs. The surface and sub-surface temperature changes in porcine tissue samples were assessed under standardised conditions. The manufacturer's patient instructions were correlated to the measured optical parameters. Calculations were made of irradiance and surface radiant exposure. Consumer satisfaction ratings and feedback data were collated, and a relevant statistical analysis conducted. Results: The results were heterogeneous with a wide range of applied wavelengths, output power and irradiance. Power output stability was variable, and, together with a wide beam divergence angle of 74°, the manufacturer's directions for dosimetry were found to be inconsistent with an accurate dose delivery. Conclusions: The manufacturer's proposed dosimetry fails to consider the relevance of the beam divergence angle and optical attenuation in view of the scatter and absorption. Appropriate instructions on how best to gain and optimise an acceptable clinical outcome were inconsistent with an evidence-based approach. Subject to validation by well-planned clinical trials, the concept of home PBMT may open interesting new therapeutic approaches.