Houston’s OrthoAccel Technologies has announced the availability of their newest product, AcceleDent Aura, to orthodontic practices throughout the United States and Canada. AcceleDent Aura’s proprietary SoftPulse Technology generates gentle micropulses that safely accelerate bone remodeling and that the company claims has been shown to accelerate tooth movement by up to 50 percent. AcceleDent represents the first successful clinical approach to accelerate orthodontic tooth movement by modulating bone biology in a non-invasive and non-pharmacological manner.
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 time could be shortened by at least 5 months during the first two stages of orthodontic treatment. This, together with excellent tolerance, lack of discomfort and ease of use reported by our patients, indicates that AcceleDent will likely become an extremely useful tool and valuable adjunct appliance in orthodontic clinical practice.”
The company cites orthodontist reports that AcceleDent Aura’s micropulses may also help reduce patient discomfort and make treatment more pleasant. By inserting the mouthpiece fitted around your existing orthodontics and wearing the activator for 20 minutes everyday, AcceleDent Aura can speed up tooth movement through the use of the device’s SoftPulse Technology and has been clinically proven to move teeth up to 50% faster in a US clinical trial. Faster tooth movement may decrease the duration of orthodontic treatment. According to OrthoAccel, SoftPulse Technology micropulses are gentle, and exert up to 8x less force than a power toothbrush. The FDA-approved AcceleDent Aura is available only by prescription from orthodontists.
“We are thrilled to present AcceleDent Aura,” says OrthoAccel CEO, Mike Lowe in a release. “AcceleDent has accelerated orthodontic treatment worldwide since 2009, and our newest product, AcceleDent Aura, brings the latest in innovative technology to the forefront. A new convenient USB connection makes charging the device simple, as well as providing access to the FastTrac patient usage report via a computer connection.”
The science behind the AcceleDent System is the result of years of research by many scientists including Dr. Jeremy Mao, DDS, PhD, inventor of the core OrthoAccel technology, chairman of the company’s scientific advisory board, and Zegarelli Endowed Chair at Columbia University College of Dental Medicine in New York. Dr. Mao’s pioneering work in the early 2000’s, which was initially conducted while he was on faculty at the University of Illinois, Chicago, was paramount in establishing the therapeutic effect of pulsatile forces in accelerating bone modeling and remodeling in the orofacial region. Dr. Mao is cited observing that “FDA clearance of AcceleDent is the culmination of sound scientific principles and proof of concept studies translated into a product that benefits society. Two independent U.S.A. clinical trials and hundreds of cases, in Europe and Australia, with children and adults treated with braces and AcceleDent, demonstrate accelerated tooth movement.”
“The Phase I Human Clinical Trial conducted at the University of Texas Dental Branch in Houston validates our previously published animal data that serves as the foundation for the concept that orthodontic treatment can be safely accelerated,” Dr. Mao is quoted commenting by Orthodontic Products Online.
Michael Kaufman , Vice President of Business Development & Marketing at OrthoAccel noted in a 2011 release that: “We have now completed two clinical trials in the U.S.A. with the AcceleDent System, and the results have consistently exceeded our expectations. With continuously increasing demand for evidence-based treatments in medicine and dentistry, we are extremely pleased to introduce the first in a series of innovative orthodontic appliances that has the ability to markedly accelerate orthodontic treatment based on sound clinical evidence.” The first clinical trial on the AcceleDent System was completed under the guidance of Dr. Jeryl English and Dr. Chung Kau at the University of Texas Health Science Center Dental Branch at Houston.
Based in Houston, Texas, OrthoAccel Technologies, Inc. is a privately owned medical device company currently engaged in the development, manufacturing, and marketing of products to enhance dental care and orthodontic treatment. AcceleDent is a simple dental device that orthodontic patients wear in the mouth for 20 minutes daily to accelerate tooth movement.
The Phase I clinical trial in 2008 in Houston, TX, above referenced, demonstrated device safety. In discussing AcceleDent with his colleagues, Dr. Chung H. Kau, DDS, MScD, MBA, PhD, M Orth, FDS, FFD (Ortho), FAMS (Ortho), the principal investigator, is cited observing: “I was encouraged by how well tolerated the device was by patients – teenagers and adults alike.”
Patients use the lightweight, hands-free AcceleDent Aura for 20 minutes each day, during which time they can freely engage in daily activities such as reading, texting or watching television. For orthodontists, offering advanced care options like AcceleDent Aura means enhanced practice differentiation. Faster orthodontic treatment promotes increased patient satisfaction, which may lead to increased patient referrals.
OrthoAccel Technologies, Inc.’s AcceleDent was launched in 2009 and has been recommended and prescribed by orthodontists worldwide. AcceleDent has also received FDA clearance as a Class II medical device.
OrthoAccel CEO Michael K. Lowe spent seven years at Philips Oral Healthcare (Royal Philips Electronics) where he worked in a variety of roles including global product management and brand management for Sonicare (Class I medical device, $350 million annual revenue). Mr. Lowe’s experience comprises a range of marketing-related disciplines including dental professional sales management, sales training, promotion and advertising, market research, pricing strategy, and channel strategy development. While at Philips, he was nominated into the prestigious High Potential global management program, was listed as a co-inventor on a business application patent related to CRM, and developed a training program, Evidence-Based Dentistry, which won a regional MEDIC process improvement award for increased dental sales. Mr. Lowe initially began working on the Sonicare business with Optiva, Inc.
For more information about the company, visit the OrthoAccel Technologies Inc. company profile on BioNews Texas.
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