Biolux Research has released preliminary results of its pilot clinical study utilizing OrthoPulse iO prototypes for accelerating orthodontic treatment.
The company has developed extraoral photobiomodulation technology and devices for dental applications involving bone regeneration, and is now focusing on an intraoral approach for orthodontics. The main benefits of intraoral photobiomodulation are increased clinical efficacy and shorter daily treatment sessions (a few minutes per arch), according to Biolux.
The pilot study was single-center and single-operator, with the primary end point being the alignment of the anterior teeth of the upper and/or lower arches in patients who had anterior crowding greater than 3 mm. 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 had an average rate of resolution of crowding (tooth movement in mm/week) of 1.40, versus the control group of 0.32, resulting in a statistically significant (p < 0.01) acceleration factor of 4.4x, according to the company. 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, compared with the average for the control group of 115 days.
Biolux has developed new intellectual property for the intraoral technology and product designs and has filed a number of U.S. patent applications that can be expanded to provide protection for the majority of the worldwide orthodontic market. The company plans to complete development and have a soft launch of the product into target markets with distribution partners by early 2014.
