Preliminary data from a clinical study indicates that patients using the light therapy device alongside clear aligners required fewer refinements and shorter treatment times.
Biolux Technology announced preliminary results from an ongoing clinical study comparing outcomes of Invisalign patients treated with and without OrthoPulse. The study, conducted by San Francisco-based orthodontist Bella Shen Garnett, DMD, MMSc, evaluated the impact of near-infrared photobiomodulation on treatment efficiency and predictability.
Clinical Study Findings
The analysis reviewed 40 completed cases, comparing 20 consecutive patients using OrthoPulse with 20 consecutive patients in a control group. According to the data, the OrthoPulse group experienced a 54% reduction in average treatment time, completing treatment in 8.3 months compared to 18.1 months for the control group.
Patients using the device also averaged 23% fewer office visits (12.8 versus 16.6) and required 49% fewer refinements (1.1 versus 2.2). Additionally, 15% of the OrthoPulse cases were completed without any refinements, whereas the control group had no cases finish without refinement. The OrthoPulse group achieved these outcomes despite starting with a slightly higher average number of initial aligner stages (25.4 versus 21.8).
Integration into Orthodontic Workflows
“One of the biggest challenges in aligner therapy is ensuring that treatment progresses as planned. These findings suggest that OrthoPulse may help reduce the need for refinements while improving overall treatment efficiency and the patient experience,” says Shen Garnett in a release.
OrthoPulse is an FDA-cleared and EU MDR-compliant medical device that utilizes near-infrared light therapy to stimulate cellular activity linked to bone remodeling. The device is designed for 10 minutes of daily use and can be prescribed with clear aligners or fixed appliances.
According to the company, this represents the first dataset from an ongoing clinical study that is expected to expand with additional cases.
Photo: Biolux Technology
