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FDA Approves Electronic Device to Detect Cavities Early


Imagine if dentists could find clear signs of tooth decay long before dental lesions turn into cavities and without using X-rays. A new device cleared for commercialization this month by the Food and Drug Administration (FDA) is a potential tool for dentists to do just that.

ECD device
The ECD is a patented lightweight tabletop device
designed as an aid for dental professionals to diagnose and monitor dental cavities.

Developed and patented by researchers in the Division of Translational Oral Biology in the Department of Oral biology and Pathology at Stony Brook University School of Dental Medicine, and licensed to Ortek Therapeutics, Inc., the Electronic Cavity Detection (ECD) System uses electrical conductance to diagnose and monitor enamel lesions on the biting surfaces of molars and premolars. Mineral loss in tooth enamel is a significant change that leads to the development of cavities. The battery-powered ECD detects this early mineral loss before a cavity forms.

In clinical trials conducted through Stony Brook School of Dental Medicine, the ECD was up to 96 percent accurate in detecting microscopic pre-cavity enamel lesions.

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.

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