Navigation Links
AcceleDent™ System, Used for Accelerated Orthodontic Tooth Movement, Receives United States FDA Clearance
Date:11/22/2011

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 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."

Michael Kaufman, Vice President of Business Development & Marketing at OrthoAccel®, remarked, "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, Houston and has since been published.

OrthoAccel® has been selling the AcceleDent™ System outside the U.S.A. since October 2009 where hundreds of orthodontic cases have been treated with AcceleDent™. As reported by orthodontists, the average orthodontic treatment time has been significantly shortened. Dr. Stewart Hawthorn, a private practice orthodontist in Winchester, UK was among the first in the world to include the AcceleDent™ System into his orthodontic treatment plan. He recently shared, "I am really surprised at how well AcceleDent™ works. It is certainly a useful adjunct to my orthodontic techniques. For those patients who are keen to reduce their treatment time I would definitely recommend it!" Indicative of the commitment to advance the understanding and efficacy of this appliance through scientific clinical evidence, OrthoAccel® has initiated clinical studies with the AcceleDent™ System in other countries. 

The science behind the AcceleDent™ System is the result of years of research by many scientists including Dr. Jeremy Mao, Professor of Orthodontics 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 remarked, "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."

Dr. Lawrence Levens, a private practice orthodontist in St Louis, MO has been anxiously awaiting the arrival of the AcceleDent™ appliance and recently stated his belief that the technology will revolutionize orthodontic treatment for patients. According to Dr. Levens, "Orthodontic manufacturers have tweaked brackets and wires for years in the hope of gaining some small advances in shortening the total treatment time patients must wear braces. That area of advancement has been tapped completely. AcceleDent™ has adapted existing technology from orthopedics that has been proven to be safe and effective in causing bones to heal more quickly and applied it to orthodontics. I can deliver the same great care to my patients but much more quickly. Who wouldn't want that?"

About OrthoAccel® Technologies, Inc.

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.

About the AcceleDent™ System

AcceleDent™ represents the first successful clinical approach to accelerate orthodontic tooth movement by modulating bone biology in a non-invasive and non-pharmacological manner. The appliance has been studied clinically as a complement to conventional fixed orthodontic appliances. It applies gentle pulsating forces to the dentition and accelerates tooth movement by stimulating a biological response of bone. More information can be found at www.acceledent.com and www.acceledent.co.uk or requested via info@orthoaccel.com


'/>"/>
SOURCE OrthoAccel Technologies, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. PharmacoFore, Inc. Announces Positive Results from a Phase I Clinical Study of Its Hydromorphone Bio-Activated Molecular Delivery™ System, and Upcoming Presentation at the 2011 BIO Business Forum During the Annual BIO International Convention in Was
2. With Launch of New ActiveHome Monitoring System, ActiveCare Announces New Head of Sales and Marketing
3. Gen-Probe Files for US Regulatory Clearance of PANTHER™ System, Fully Automated and Integrated Molecular Testing Instrument
4. Announcing 510(k) Clearance of a New Microfluidic-based IVD Test System, the uTASWako® i30 Immunoanalyzer, and AFP-L3 and DCP Assays for Liver Cancer Risk Assessment.
5. Breast Enlightenment Presents Breast Angel, the First Home Care Breast Health System, to Prevent Breast Cancer
6. Regado Biosciences, Inc. Presents Two Abstracts on the Subcutaneous Depot Formulation of Pegnivacogin, a Nuclease-Stabilized RNA Aptamer, Direct Factor IXa Inhibitor and Part of the REG2 Anticoagulant System, at the American Heart Association (AHA)
7. MedClean Technologies Signs Contract with Gamma HealthCare Inc./Danner Medical Waste for MedClean 4500 Fixed-Based System, Services, and Consumables
8. The Vanishing Oath, the First Physician-Focused Documentary on the Dangers of the American Healthcare System, Launches on DVD May 5
9. Solta Medical Announces New Fraxel re:store(R) Dual Laser System, Receives CE Mark for European Market
10. Medinol Receives CE Mark for Presillion(TM) Cobalt Chromium Coronary Stent on Rx System, an Advanced Evolution of the NIR(R) Family of Stents
11. Echo Therapeutics Announces Positive Results with the Prelude(TM) SkinPrep System, the Next-Generation Skin Permeation Medium for its Symphony(TM) Transdermal Continuous Glucose Monitoring System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... 2017 The top three players ... Healthcare, Koninklijke Philips N.V., and Schiller. Collectively, these companies ... market in 2015. Strong product portfolio and a monumental ... be aiding these players remain leaders in the fragmented ... in the global market are likely to focus on ...
(Date:2/23/2017)... YORK , February 23, 2017 ... end of day as four out of nine sectors finished ... one sector managed a flat closing. Major US indices were ... Composite ended the day at 5,860.63, slightly down by 0.09%; ... at 20,775.60; and the S&P 500 closed at 2,362.82, down ...
(Date:2/23/2017)... , Feb. 23, 2017   SeraCare Life ... global in vitro diagnostics manufacturers and clinical laboratories, ... "Catalyzing Implementation of NGS-Based Tests" to be hosted ... 2017 at 11am Eastern Standard Time (US). ... highlight the need for improved performance and global ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased ... KLS is a longtime supporter of the event. , "We are pleased that KLS ... Dr. Bob Havlik, 2017 ACPA President. "KLS Martin has a long track record of ...
(Date:2/23/2017)... Angeles, California (PRWEB) , ... February 23, 2017 ... ... Global Sports Development will host a diverse symposium on “Doping in ... of Law and Sheppard Mullin Richter & Hampton LLP. The symposium will be ...
(Date:2/23/2017)... ... February 23, 2017 , ... Healthcare Research & ... in the fight against cancer, has produced a seminal study that asked cancer ... release top-line findings in a webinar, Defining Compassionate Care Through the Voices of ...
(Date:2/23/2017)... ... February 23, 2017 , ... Curemark, LLC announced today that the Blüm ... in children aged 3-8 with Autism, is now enrolling at three new sites. These ... the United States. , “There are currently no approved drugs that address the ...
(Date:2/22/2017)... , ... February 22, 2017 , ... ... athletics. It’s enough to overwork even the sharpest brain. , Power On, a ... healthy activity without over clocking the brain. Each capsule contains Cognizin® Citicoline, a ...
Breaking Medicine News(10 mins):