Randomized Study of OrthoPulse Light Therapy to Speed Up Tooth Movement with Braces

What this Trial Is About

Researchers are evaluating the safety and performance of the OrthoPulse photobiomodulation device to speed up tooth movement during orthodontic treatment with fixed braces. This post-market clinical follow-up PMCF study aims to confirm if patients using OrthoPulse experience a faster rate of tooth alignment compared to those receiving standard treatment. The study is sponsored by Biolux Technology GmbH and involves adults requiring orthodontic care with permanent teeth. The study includes two groups one using the OrthoPulse device alongside fixed braces and a control group receiving standard orthodontic treatment without the device. OrthoPulse is a light-emitting diode LED device that delivers near-infrared light inside the mouth to stimulate bone activity and potentially accelerate tooth movement. The study plans to enroll 41 patients, with about half in each group. Participants will be monitored for the rate of tooth alignment over a period of 42 days after starting treatment. Assessments include measuring how quickly teeth move during the alignment phase of orthodontic treatment. Researchers will track safety and treatment progress without masking or blinding. The total duration and follow-up details are based on the alignment phase and device usage during this time.

Study of the Use of Orthopulse Photobiomodulation