STIMULATING CELLULAR ORTHODONTIC ADVANCEMENT

orthcell

“Cutting in Half Orthodontic Brace and Aligner Wear Time with Bioelectric Stimulation”

OrthodontiCell (patent pending) has the mission to reduce in half or more, the time that it takes to complete orthodontic treatment and then have the teeth become stable in their final position equally as rapidly.  This is all made possible by wearing a bioelectric stimulation mouthpiece only 3 times a week for 20 minutes.

Orthodontic braces and clear aligners work by applying force to teeth in order to gradually realign them.  This force naturally causes a demineralization (softening) of the bone, which allows the teeth to move. Although the time it takes for patients to wear braces or aligners varies considerably, it generally takes on average up to 2 years. To help shorten treatment time, Dr. John Marchetto of Weston, FL and Howard Leonhardt of Salt Lake City, UT has formed OrthodontiCell (Salt Lake City, Utah).  OrthodontiCell has developed the Tooth Movement Accelerator TM, which uses bioelectric energy to significantly increase the rate at which teeth move during orthodontic tooth movement. The Tooth Movement Accelerator TM is a removable and non-invasive appliance that a patient wears in the mouth for 20 minutes every 3 days.  OrthodontiCell is working with Dr. Jorge Genovese of Argentina (also a co-founder) and is about to commence animal studies utilizing the bioelectric energy, at the Forsyth Institute in Cambridge, MA.  This study will then be followed using the device and method in controlled clinical trials in the USA.

The technology is based on patent pending bioelectric stimulation technology originally developed to regenerate damaged hearts back in 1999 and is now adapted and reprogrammed for increasing the rate of tooth movement and thereby reducing orthodontic treatment time.  The OrthodontiCell Tooth Movement Accelerator TM emits small electric pulses that controls expressions of RANKL, OPG, TNF-alpha, SDF-1, HGF, IGF-1, VEGF, eNOS and M-CSF as well as stem cell differentiation.   Studies and patents (some with patents pending) have been completed for all these cells and proteins individually for various applications of regeneration.  Previously, a number of studies have demonstrated that regular needle injections of RANKL in the area of desired tooth movement, accelerates tooth movement by 300% and will decreases the time needed to wear braces or aligners.

This bioelectric stimulator, will achieve incredibly fast orthodontic treatment with less pain, in fact, the electrical stimulation actually has a pain reducing affect.   When compared to surgical corticotomies (the well documented surgical approach to acceleration tooth movement), it was faster, eliminates the morbidity, pain and suffering of surgery.  The key to the increased rate of tooth movement is drawing an abundance of the needed cells and proteins to the site of tooth movement.  These cells and proteins will accelerate the demineralization (softening) of bone, thereby allowing teeth to move faster.  Once the teeth are in their final proper position, signaling for an increase in specific cells and proteins will accelerate the remineralization (hardening) and shorten the time for retention.  One example is SDF-1, a key patented signal for homing stem cells from the surrounding tissue (bone marrow, gum tissue, fat cells and circulating blood) to come to the treated site to aide in tooth movement.  There are many other cells and proteins and cytokines that have an increased expression through specific patented signals, all working together to substantially increase the rate of tooth movement.

Howard J. Leonhardt the Founder and CEO of Leonhardt Ventures and Cal-X Stars Business Accelerator, Inc., Dr. John Marchetto an Orthodontist in Weston, Florida and Dr. Jorge Genovese a collaborative researcher from Buenos Aires, Argentina are co-inventors of this product.

“This invention addresses the desire to reduce in half or more, the time it takes to treat orthodontic patients.  The approach is to speed up the normal process of bone demineralization in order to accelerate tooth movement.  Millions of people that wear braces or aligners would love to cut their treatment time by more than half.  Other devices that use light or vibration fall very short in reducing treatment time because they do not provide a clear and reliable pathway to the underlying mechanism of action for tooth movement.  Additionally, they have no effect on helping to stabilize and improve retention after the orthodontic treatment is completed.  This invention is completely different than previous devices as it provides clear cut direct control for the release of essential cells and proteins needed for accelerating tooth movement, and with less pain”, states Dr. John Marchetto, co-Inventor.

Link to news release…

Device to Cut Orthodontic Treatment Time in Half …

https://www.prbuzz.com/…/372828-device-to-cut-orthodontic-treatment-…

20th, 2016 – PRBuzz – Leonhardt Ventures — a developer, manufacturer and … OrthodontiCell is incubating within Cal-X Stars Business Accelerator, Inc. The …

OrthodontiCell is a startup in the Leonhardt’s Launchpads Utah innovation accelerator a unit of Cal-X Stars Business Accelerator a Leonhardt Ventures Co.

OrthodontiCell

A Leonhardt Ventures Co.

@ Leonhardt’s Launchpads Utah

489E, 400 South, Unit 116

Salt Lake City, Utah 84111

954 401 0096 Howard Leonhardt

954 812 4238 Dr. John Marchetto

Email: howard.leonhardt@orthodonticell.com

john. marchetto@orthodonticell.com

Media Relations:  Brian Hardy – brian@fizzpopmedia.com

Bioelectric Stimulation Induced RANKL and OPG Release in Rats for Controlled Tooth Movement

Bioelectric Stimulation Induced RANKL and OPG Release in Rats for Controlled Tooth Movement

Sercan Akyalcin, Alpdogan Kantarci, Susan Baloul, Howard Leonhardt, John Marchetto

Tufts University School of Dental Medicine, Department of Orthodontics

Forsyth Institute

Introduction:

Receptor activator of nuclear factor kappa B ligand (RANKL) and Osteoprotegerin (OPG) are critical determinants in alveolar bone remodeling during and after orthodontic tooth movement (TM). The paradigm is that RANKL expression accompanies alveolar bone resorption on the compressed side of the tooth and is affiliated with accelerated tooth movement when enhanced locally while OPG enhanced expression inhibits RANKL-mediated osteoclastogenesis and stimulates osteoblastic bone apposition. Specific bioelectric stimulation offers a non-invasive mechanism to induce the controlled release of RANKL/OPG in the areas of interest.

Hypothesis:

Specific and sequential bioelectric stimulation of RANKL and OPG will alternate acceleration of TM followed with enhancement of its stability.

 

Aim:

The hypothesis will be tested by two aims using an established experimental TM model in rats.

Specific Aims:

  1. To investigate the impact of specific and sequential bioelectric stimulation of RANKL on acceleration of TM.
  2. To evaluate the stabilizing potential of bioelectric stimulation of OPG on TM.

Methods:

Animal Model: During the first phase of the study (Aim 1), sixty young adult rats will be divided into three groups: RANKL induction group (n=20), RANKL/OPG induction group (n=20), and control (n=20) group. Orthodontic tooth movement in all three groups will be accomplished by superelastic NiTi close-coil springs placed between the maxillary molars and miniscrews placed in the palatal aspect of the maxillary arch. The coil springs will be adjusted to deliver a constant force of 35 centinewtons to protract the molars with no additional reactivation during the experimental period. Bioelectric signals will be delivered to the molars by using a customized mouthguard connected to a benchtop stimulator. The RANKL induction group will receive bioelectric stimulation signal for RANKL of 3mv at 2/100 HZ with current of 3ma applied for 20 minutes and followed by 15HZ 1 Guass EM field consisting of 5 millisecond bursts with 5 microsecond pulses for 5 minutes followed by 200 ms pulse duration @ 30 Hz with current amplitude of 140ma for 5 minutes (30 minutes total, each cycle) three days a week during the study (21 days).  The RANKL/OPG induction group will receive a promoting bioelectric signal controlling the release of OPG  (4mv 100hz) also the RANKL stimulation protocol for one hour at three time periods between the 14th and 21st days. The control group will receive bioelectric stimulation without stimulating a specific target for the duration of the study. At the end of the 21 days, half of the animals will be sacrificed.

During the second phase of the study (Aim 2), appliances will be removed. The remaining 30 animals will be observed for another 21 days with RANKL/OPG group receiving specific and control group receiving nonspecific bioelectric stimulation. 

Evaluation of the rate and magnitude of tooth movement and quality of bone by microCT: Tooth movement and bone mineral density will be evaluated using microtomography (micro-CT) at baseline, 21st, and 42nd days.

Histomorphometry and Immunohistochemistry: Animals will be sacrificed at the end of the each experimental period (21 and 42 days) and will be subjected to immunohistochemical analysis for a total count of osteoclasts and osteoblasts around the dental structures by TRAP staining. Histomorphometric analyses will be performed by H&E staining after decalcification of samples. Expression of RANKL and OPG will be examined by immunohistochemical staining.

Anticipated Outcomes:

  1. Sequential bioelectric stimulation of RANKL and OPG will help accelerate and stabilize orthodontic tooth movement effectively.
  2. Consecutive expression of RANKL and OPG will result in less orthodontic TM and less relapse compared to isolated RANKL expression and control groups.