This Small Business Innovation Research project aims to develop hard ceramic coatings that will reduce the sliding resistance of archwires in their brackets during orthodontic treatment procedures. Excessive sliding resistance, which is a combination of friction and notching/binding behavior, works against tooth motion as the bracket slides along the wire into a new position, resulting in less predictable outcomes, and requiring increased force, treatment time, 'chair time,' and patient costs. If successful, the hard coatings will decouple sliding resistance from other properties of the arch-wire material, such as stiffness and provide the practitioner with new material systems for solving specific patient problems. Phase II will continue and expand highly promising Phase I results, in which thin coatings of alumina, zirconia, and titania were applied by ion beam assisted deposition (IBAD). The coatings decisively reduced sliding resistance of archwires in tests conducted by a major manufacturer of orthodontic appliances. The testing showed major reductions of both sliding friction and notching/binding behavior; and two of the coating materials demonstrated high resistance to scratching and delamination. The Phase II program will improve on coating properties through optimization of IBAD parameters, evaluate the coated archwires by in vitro testing in a more realistic configuration, and make a final selection of coating material and deposition parameters for a clinical study. Coated archwires will be evaluated in a limited clinica study at a major research university to test their efficacy in early and intermediate stages of tooth straightening in children. The commercialization potential of ceramic-coated orthodontic archwires is very high, as already demonstrated by the Phase I involvement by our industrial collaborators in laboratory testing. Phase III commercialization would be a straightforward expansion of Spire Biomedical's coating and surface- modification business, which specializes in surface treatments for orthopedic prostheses, catheters, and other medical devices.

Public Health Relevance

In this program; nano-crystalline ceramics will be applied to the surface of orthodontic archwires using ion beam assisted deposition to reduce sliding resistance. Excessive sliding resistance works against tooth motion as the bracket slides along the wire into a new position. These ceramic coatings will produce more predictable outcomes; requiring less force; shorter treatment time; and decreased patient costs. A limited clinical trialwill be conducted to demonstrate these effects.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
6R44DE022218-03
Application #
8819807
Study Section
Special Emphasis Panel (ZRG1-MOSS-K (11))
Program Officer
Drummond, James
Project Start
2011-07-01
Project End
2015-08-31
Budget Start
2014-03-01
Budget End
2014-08-31
Support Year
Fiscal Year
2014
Total Cost
$723,808
Indirect Cost
Name
N2 Biomedical, LLC
Department
Type
DUNS #
079141140
City
Bedford
State
MA
Country
United States
Zip Code
01730