AcceleDentâ„¢ System, Used for Accelerated Orthodontic Tooth Movement, Receives United States FDA Clearance(2)
HOUSTON, Nov. 22, 2011 /PRNewswire/ -- OrthoAccel® Technologies, Inc., developer of the AcceleDent™ System, an appliance designed to accelerate orthodontic treatment, announced that it has received FDA clearance and is preparing to launch the product throughout the United States.
AcceleDent™ is a simple, removable and non-invasive appliance that a patient with braces wears in the mouth for 20 minutes per day to accelerate orthodontic tooth movement. A randomized, controlled clinical trial conducted at the University of Texas Health Science Center at San Antonio, under the guidance of Dr. Dubravko Pavlin, Professor of Orthodontics, demonstrated, with statistical significance, that tooth movement could be accelerated by 106% during the initial alignment phase and 38% to 50% during closure of extraction space. There was no evidence of damage (resorption) of tooth roots or any other adverse events caused by the appliance, thus demonstrating an excellent safety profile. Dr. Pavlin commented, "The evidence for faster tooth movement with the use of AcceleDent™ is welcomed by both orthodontists and patients since it may result in shorter orthodontic treatment time. With an increase in rate of tooth movement observed in our study the orthodontic treatment