The Food and Drug Administration (FDA) has awarded 510(k) clearance to the Ortek ECD from Ortek Therapeutics. The patented, lightweight, battery-powered, tabletop device is designed to help dental professionals diagnose and monitor dental cavities in the biting surfaces of molars and premolars.
In a pair of clinical trials conducted by the Stony Brook University Department of Oral Biology and Pathology, the ECD system was up to 96% accurate in detecting microscopic pre-cavity enamel lesions without exposure to radiation from x-rays. There were no false readings in either study.
The ECD was developed in the Division of Translational Oral Biology at Stony Brook University and exclusively licensed to Ortek from the Research Foundation of the State University of New York.
“This device will help dental professionals diagnose and monitor pre-cavitated lesions in enamel that cannot be predicted by x-rays. This will enable the dental practitioner to design an appropriate treatment plan that could include minimally invasive care,” said Israel Kleinberg, DDS, PhD, DSc, director of the Division of Translational Oral Biology.
The ECD uses electrical conductance to accurately diagnose and monitor enamel lesions. Tooth enamel is electrically non-conductive unless breached by fracture or demineralization. When teeth begin to lose minerals, dentinal fluid from within the tooth percolates through the breached enamel site and enables the ECD to complete its electrical circuit.
The ECD’s handpiece uses a novel probe tip to precisely measure the amount of dentinal fluid in the pits and fissures of molars and premolars. The more fluid the ECD detects, the greater the severity or extent of the cavity or pre-cavity enamel lesion. This data is numerically displayed on the ECD base unit.
“The ECD is a pain-free system and is designed to rapidly aid dental professionals to diagnose and monitor enamel lesions in the grooves of the back teeth,” said Mitchell Goldberg, Ortek president. “These tooth surfaces have the highest rates of decay, especially in children.”
Ortek expects the ECD to be commercially available next year. Patents covering the ECD have been awarded throughout the world and in the United States.