- Innovative device is FDA cleared and found 100% accurate in clinical study

- University developed device does not use ionizing radiation

Ortek announced today the widespread availability of its ECD device, which provides dental professionals a new diagnostic tool for the early detection of cavities that are often not picked up by X-rays. The Ortek-ECD® is a breakthrough electronic early cavity detection system that has been cleared by the FDA and is in use by hundreds of dentists throughout the United States. Without using ionizing radiation, the ECD allows dentists to detect a cavity before it can severely damage teeth.

The ECD was specifically designed to detect cavities on the chewing surfaces of molars and premolars. These tooth surfaces are most affected by decay and are a major diagnostic challenge for dentists. The ECD was developed, patented and clinically tested at Stony Brook University School of Dental Medicine and exclusively licensed to Ortek. The ECD demonstrated 100% sensitivity and 93% specificity in a published peer-reviewed clinical study. The ECD is fast, easy to use, and does not cause pain or discomfort for the patient.

Using the ECD, a dental professional gently places a stainless steel tip in the grooves of molars and premolars. By measuring the conductivity of enamel, the ECD immediately displays a quantitative digital cavities score, allowing dental professionals to accurately and quickly recommend appropriate treatment options, including minimally invasive procedures.

"The Ortek-ECD is a vital instrument to aid in the diagnosis of cavities that might otherwise go undetected," said Howard Glazer, DDS FAGD, and Past President of the Academy of General Dentistry. "It allows for early intervention and minimizes the loss of tooth structure."

"Globally, it is estimated that 2.3 billion people suffer from cavities of permanent teeth and approximately ninety percent of Americans over 20 have had cavities at some point in their lives," said Mitchell Goldberg, President of Ortek Therapeutics, Inc. "The ECD is a major technological innovation that will significantly improve patient outcomes by helping avoid the unwanted consequences of more advanced tooth decay."

The Technology

Powered by a 9 volt battery, the patented ECD is a small portable device that has a base unit with a digital display, and a handpiece with a novel stainless steel tip that touches the bottom of pit and fissures, the grooves of molars and premolars. It's been estimated that 70%-90% of tooth decay occurs in these vulnerable sites.

A tooth is considered cavitated if demineralization breaches the enamel and exposes the underlying dentin, which contains fluid filled tubules. When cavitation occurs, hydrostatic pressure will allow minuscule amounts of conductive dentinal fluid to enter the breached enamel site, causing the ECD to complete an electrical circuit, thereby detecting a cavity.

As this demineralization or cavity activity progresses, more dentinal fluid enters the breached site. The more fluid detected results in a higher current and an increasing digital cavity score that is digitally displayed from 01-100. When the enamel at the bottom of a pit or fissure is intact, no current can flow and the ECD will display a zero score. This indicates a healthy tooth or a non-cavitated lesion.

To learn more about the Ortek-ECD, visit www.ortekecd.com