Biolux Research Ltd, Vancouver, Canada, has announced plans to develop a new photobiomodulation product, OrthoPulse iO™, for accelerating orthodontic treatment. To date, the company has developed extraoral photobiomodulation technology and devices for dental applications involving bone regeneration.
The company also announced preliminary results of its pilot clinical study utilizing OrthoPulse iO prototypes. The single-center, single-operator study had as its primary endpoint the alignment of the anterior teeth of the upper and/or lower arches in patients who had anterior crowding greater than 3 mm (utilizing Little’s Irregularity Index). The study compared an OrthoPulse iO treated group (N=9) to a control group (N=11), with all patients treated with the same mechanics.
Results showed the treated group of patients demonstrated an average rate of resolution of crowding (tooth movement in mm/wk) of 1.40, versus the control group of 0.32, resulting in a statistically significant (p<0.01) acceleration factor of 4.4x. An analysis of overall treatment time for the alignment phase in the completed patients showed that the average time for the treated group was 41 days (SD=24) compared to the average for the control group of 115 days (SD=38).
The device includes LED light technology embedded within a sealed intraoral mouth guard design made of biocompatible materials. The device is self-enclosed and battery-powered.
The company says it has developed significant new intellectual property for the intraoral technology and product designs, and has filed a number of US and Patent Cooperation Treaty patent applications that can be expanded to provide protection for the majority of the worldwide orthodontic market. Biolux Research intends to complete development and soft launch the new product into target markets with distribution partners by early 2014.
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