OrthoAccel Technologies, Inc.

OrthoAccel Technologies, Inc.

Type	Private company
Industry	Medical devices
Founded	Houston, Texas, 2007
Key people	Michael K. Lowe (CEO)
Products	AcceleDent
Website	acceledent.com

OrthoAccel Technologies, Inc. is a privately owned medical device company based in Houston, Texas. Founded in 2007, OrthoAccel Technologies is most notable for developing AcceleDent, a device which uses "micropulses" to accelerate tooth movement when used in conjunction with dental braces. The product was released in the European and Australian markets in 2009,^[1] South Korea in 2012,^[2] and the United States since 2012.^[3] OrthoAccel's revenue increased approximately 300 percent from 2011 to 2012,^[4] and the following year OrthoAccel began selling AcceleDent in Canada.^[5] Around 40,000 AcceleDent units had been shipped to American practices as of June 2015.^[6]

History

OrthoAccel Technologies, Inc. was founded in 2007 in Houston, Texas, and a prototype for AcceleDent was developed in 2008.^[7] Originally the technology was being designed for "bone metabolism by orthopedics," where "low-magnitude, high-frequency vibrations" would stimulate bone into remodeling at a faster rate.^[6] Among the original developers was Dr. Jeremy Mao, who was then on the faculty at the University of Illinois.^[8] Later redesigned to focus on the jaw, AcceleDent is non-invasive and uses the application of micropulses to accelerate orthodontic tooth movement.^[9] Early clinical testing began in 2008 in Houston.^[1]

AcceleDent was marketed in Europe in 2009,^[7] with the first implementation of the device taking place in October 2009 at a private practice in the United Kingdom.^[1] In late 2009, the Australian Therapeutic Goods Administration approved AcceleDent for the Australian market on a limited basis.^[1] In February 2010, OrthoAccel received clearance from the Korean Food and Drug Administration (KFDA) to officially market AcceleDent in South Korea. The company Inno DMC was announced as the sole AcceleDent distributor in the country.^[2]

In the United States, AcceleDent was enrolled in an FDA Investigational Device Exemption (IDE) study in 2009, with the study concluding that the product could reduce treatment time by up to 56%. After the study, the FDA approved AcceleDent as a Class II Medical Device in 2011.^[7] AcceleDent was released in the US market in 2012, and AcceleDent Aura, the next version of the product, was subsequently released in 2013.^[7] Dr. John Graham was the first orthodontist to use the device in the United States, particularly in Arizona and Utah.^[3] OrthoAccel's revenue increased approximately 300 percent from 2011 to 2012.^[4]

In March 2013, the company received clearance from Health Canada to expand into the Canadian market. Dr. Paul Korne, former president of the Canadian Association of Orthodontists, had been one of the figures in Canada petitioning for the devices' approval.^[5] A review of the product was published in November 2014 in the Journal of Clinical Orthodontics, titled "The Effect of Vibration on the Rate of Leveling and Alignment."^[10] By June 2015, around 40,000 units had been shipped by OrthoAccel to around 2,500 American practices.^[6]

AcceleDent

AcceleDent

Product type	Medical device
Produced by	OrthoAccel
Country	United States
Introduced	2009
Markets	Europe, Australia, South Korea, United States, Canada
Website	Acceledent.com

AcceleDent is the primary product line produced by OrthoAccel Technologies. There have been two models created to date, AcceleDent and AcceleDent Aura. AcceleDent has been in use in both Europe^[1] and Australia since 2009,^[1] and South Korea since 2010.^[2] It was released in the United States market in 2012,^[3] and Canada in 2013.^[5] There have been a number of studies looking into the device's safety and effectiveness.^{[11][12][13][14][15][16]} As a Class II, FDA cleared medical device, Acceledent is only made available to patients via prescription from an orthodontist.^[17]

Features

AcceleDent is a hands-free orthodontic device^[18] that produces a "30 hertz vibration"^[19] accelerating bone remodeling, a key component of tooth movement^[18] and the speed with which braces and other orthodontic devices work.^[20] The device is used in conjunction with braces, either bracket braces or clear aligners,^[21] and increases tooth movement^[19] by thirty eight^[8] to fifty percent in orthodontic treatment.^[19] According to KING5, "on average, patients wear braces about 18 months without the Acceledent device and half the time with it."^[19] The patient bites down on the portable AcceleDent device^[8] for twenty minutes per day.^[21] It uses a USB port for charging and computer connection to AcceleDent’s FastTrac Usage report.^[8]

Research

Early trials on rate and safety

There have been a number of studies and clinical trials on the effects of the AcceleDent device.^[16] A study in 2010, published in the magazine Orthodontic Practice US, concluded that the device did indeed increase tooth movement.^[16] After having published the same conclusion in November 2009 in a study for Aesthetic Dentistry Today,^[12] in August 2011 Chung H. Kau published a second paper on AcceleDent in Head & Face Medicine. Kau concluded that use of the device did not impact root length, and that for the 14 patients who finished the clinical trial, no clinically significant changes between root lengths were noted above 0.5 mm."^[14]

A study was also done on the treatment time of patients with more severe reconstructive surgery as compared to conventional orthodontics, in part via the conclusions of private practitioners.^[13] According to the London-based Dr. Asif Chatoo, there was an estimated 25% reduction in treatment time for a patient "using lingual braces and requiring surgery to correct a skeletal discrepancy," with Dr. Chatoo stating in 2011 that "I predicted a treatment time of 24 months. This was an average treatment-time prediction based on my experience in treating similar cases with lingual braces and orthognathic surgery. Treatment [with this patient] was successfully completed in 17.5 months."^[15]

Recent follow-up studies

Dr. S. Jay Bowman published a study of the device in 2014 in the Journal of Clinical Orthodontics, concluding that AcceleDent did increase the rate of tooth movement, and that "even if treatment time were not a significant issue for many patients and practitioners, the prospect of improving the effectiveness of biomechanics through enhanced tooth movement would be a worthy goal."^[11]

In 2015 Peter T. Gakunga et al performed trials with AcceleDent. In a paper titled "Cyclic loading (vibration) accelerates tooth movement in orthodontic patients: A double-blind, randomized controlled trial," they again studied the speed of tooth movement when AcceleDent was used in conjunction with braces. The research closely followed a recent paper which had found flaws in the pre-existing clinical trials on tooth movement, and which had further claimed there was a "lack of quality randomized clinical trials that would allow for an evidence-based approach." Gakunga et al went on to perform a trial similar in nature to previous studies, but claimed that they used mechanics that "maximized the reproducibility of orthodontic force application and measurement of tooth movement." The study would conclude that "the application of cyclic loading (vibration) of 0.25 N (25 g) at the frequency of 30 Hz, as an adjunct to treatment with a fixed orthodontic appliance, significantly increases the rate of orthodontic tooth movement."^[17] The study further concluded that competitive brands such as the Tooth Masseuse had "no effect" on the rate of tooth movement, likely because the Tooth Masseuse was "never intended or designed to accelerate tooth movement: its output frequency is four times higher compared to our [with AcceleDent], while the force is about four times lower."^[17]

Awards and nominations

Further reading

Articles and studies

• "The clinical evaluation of a novel cyclical force generating device in orthodontics" (PDF). Orthodontic Practice US. 2010. 
• "A radiographic analysis of tooth morphology following the use of a novel cyclical force device in orthodontics". Head & Face Medicine. August 9, 2011. 
• "The Effect of Vibration on the Rate of Leveling and Alignment". Journal of Clinical Orthodontics. November 2014. 
• "Cyclic loading (vibration) accelerates tooth movement in orthodontic patients: A double-blind, randomized controlled trial". Seminars in Orthodontics. 2015. 

See also

• Accelerated orthodontic treatment
• Medical device

References

External links

• Acceledent.com