Orthodontics Clinical Trial
Official title:
A Randomized and Controlled Study of the Use of Orthopulse Photobiomodulation for Acceleration of Orthodontic Tooth Movement With Fixed Appliances
This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.
The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets). ;
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