Ortek Therapeutics announced that the Ortek ECD™ received 510(k) clearance from the U.S. Food and Drug Administration. The ECD is a patented lightweight tabletop device designed as an aid for dental professionals to diagnose and monitor dental cavities in the biting surfaces of molars and premolars. In clinical trials, the ECD system detected the earliest forms of mineral loss in enamel well before an actual cavity was formed. These pre-cavity lesions were discovered without exposure to radiation from x-rays. 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 State University of New York.
In two clinical trials conducted through Stony Brook University Department of Oral Biology and Pathology, the ECD was up to 96% accurate in detecting microscopic pre-cavity enamel lesions in the biting surfaces of molars and premolars. There were no false negative readings in either study.
The ECD was developed by a team of researchers led by Israel Kleinberg, DDS, PhD, DSc, Distinguished Professor in the Department of Oral Biology and Pathology, and Director of the Division of Translational Oral Biology at Stony Brook. “We believe the ECD is a new paradigm in oral care,” said Dr. Kleinberg. “This device will help dental professionals diagnose and monitor pre-cavitated lesions in enamel that cannot be detected by x-rays. This will enable the dental practitioner to design an appropriate treatment plan that could include minimally invasive care.”
A battery-powered device, 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 features a handpiece with a novel probe tip and can 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 FDA clearance for the ECD is a significant milestone for Ortek and a new, important tool for dental professionals,” said Mitchell Goldberg, President of Ortek. Dental cavities are the most prevalent chronic disease globally. Throughout the world, 60–90% of school-age children are affected by tooth decay and approximately 2.5 billion people suffer from untreated dental cavities. “The ECD is a safe pain-free system and is designed to rapidly aid dental professionals to diagnose and monitor enamel lesions in the grooves of the back teeth. These tooth surfaces have the highest rates of decay, especially in children,” continued Goldberg.
Ortek anticipates the ECD will be commercially available next year. Patents covering the ECD have been awarded throughout the world and in the United States.