A. The Ortek-ECD™ (ECD) is a breakthrough noninvasive patented electronic caries detection device that helps dental professionals diagnose and monitor early cavitated lesions in the pits and fissures located on the occlusal surfaces of posterior teeth. The ECD is a small portable device that has a base unit with a digital display, a handpiece with a dimensionally configured single patient use stainless steel tip that reaches to the bottom of a pit or fissure and a reference lip hook.
By measuring the conductivity of enamel, the ECD can identify these very prevalent lesions usually before x-ray, probing and visual methods. The ECD does not use ionizing radiation, is painless and not affected by stain.
Q. How does the ECD work?
A. The ECD is an electronic caries detection device that measures the conductivity of enamel. If the dentin-enamel junction is breached by demineralization, hydrostatic pressure that exists within dentinal tubules will allow minuscule amounts of conductive dentinal fluid to enter the breached enamel site, allowing the ECD to complete an electrical circuit.
Loss of mineral from enamel as a result of caries activity increases porous size and enamel porosity. As this demineralization increases, more dentinal fluid enters the breached site. The more fluid detected results in lower resistance, a higher current and an increasing digital caries score that is digitally displayed from 0-100.
Intact tooth enamel is a good insulator and is electrically non-conductive. When the enamel at the bottom of a pit/fissure is intact, the circuit path is opened, and no current can flow, indicating no lesion and a zero score.
Q. How do you operate the ECD?
A. Operating and setting up the ECD is fast and easy. Simply connect the Y connector cable to the main unit. Then connect the handpiece and the lip hook into the Y connector cable as indicated in the instructions for use. Insert the single patient use stainless steel tip into the handpiece. The tip needs to be sterilized before use.
Place the lip hook in the patient’s mouth. Isolate the tooth being examined with cotton rolls, and thoroughly air dry the tooth site with a 4-second blast of dry air from a dental air syringe. With little or no pressure, gently place the tip at the bottom of a pit or fissure. Do not explore the tooth by a conventional tactile examination, which can cause damage to the enamel surface.
An audible beep will sound if a lesion is detected. If no beep is heard, examine the next tooth or site. If a beep is heard, hold the tip in position until the beep stops, and then remove the tip. The beep indicates that a carious lesion has been detected due to the completion of an electrical circuit. The ECD screen will display a numeric value for 3 seconds. Wait for the ECD Screen to reset to zero before examining the next site or tooth. Click here for User Manual.
Q. What is the relation between ECD display results and caries status?
Enamel/ Dentine Caries Status
|00||No||High probability of a sound enamel site.|
|Indication of initial caries lesion breaching the dentin-enamel junction.|
|02 – 03||Yes||Indication of caries lesion with the likelihood of dentin involvement.|
|04 – 20||Yes||Indication of caries lesion advancing into the dentin.|
|21 – 60||Yes||Indication of caries lesion progressing into the dentin.|
|61 – 100||Yes||Indication of an advanced caries lesion.|
*Any final diagnosis and /or treatment decision is the responsibility of the dentist who should be integrating all the information available, particularly that from clinical visual and radiographic caries examination.
** If an increasing amount of dentinal fluid is detected, a beep alert will occur.
Q. Where is the ECD available for sale?
A. The ECD was cleared by the U.S. Food and Drug Administration and is only available for sale in the United States.
Q. How do I purchase the ECD?
A. The ECD is only available direct from Ortek Therapeutics, Inc., and can be purchased at ecddetect.com.
Q. What is included when I purchase the ECD?
A. The purchase of the Ortek-ECD™ includes the device main unit, one handpiece, a package of (20) non-sterile single patient use tips, a Y connector cable, two lip hooks and a 9V alkaline battery.Q. What is the clinical evidence supporting the ECD?
A. An in vitro study was performed to detect occlusal caries lesions of 39 extracted permanent human molars by electrical conductance measurement with the ECD and each tooth was sectioned and biopsied to validate and evaluate results.
Electrical conductance versus biopsy proved to be (100.0%) sensitive and had a high specificity (93.0%). At the same time, it showed a positive predictive value (PPV) of 96.0% and a negative predictive value (NPV) of 100.0% for electrical conductance versus biopsy.
Q. Where can I review the complete study?
A. The study was published in the Journal of Clinical Dentistry, a peer reviewed publication. Click here to review the study.
Q. Where was the ECD developed?
A. The ECD was patented, developed and tested at Stony Brook University School of Dental Medicine and licensed to Ortek on an exclusive worldwide basis.
Q. How will the ECD benefit my patients?
A. Dental caries remains one of the most common chronic diseases in humans. Approximately 80% to 90% of tooth decay in permanent teeth occurs on the occlusal surfaces of posterior teeth. Early lesions in these vulnerable sites often go undetected by x-ray, probing and visual methods. The ECD is a painless, noninvasive device that does not use ionizing radiation, and may negate the need of potentially harmful probing. Diagnosing and monitoring these very early cavitated lesions can allow dental professionals to practice minimally invasive dentistry, or preform conservative restorative techniques that help minimize the loss of healthy tooth structure.
Q. How will the ECD benefit my practice?
A. Incorporating the ECD into your practice has numerous advantages. These include dramatically enhanced patient care and wellness, confirming treatment options, a very rapid return on investment, a new profit center, building trust with your patients and attracting new ones. The ECD is easy to use with minimal training and maintenance.
Q. When should the ECD be used?
A. The ECD is a valuable tool for nearly every dental office and should be used during routine hygiene exams. Additionally, the ECD can help dental professionals diagnose and monitor suspicious occlusal lesions, and confirm treatment options.
Q. Are there insurance codes applicable to the ECD?
A. ADA CDT Code D0600
Non-ionizing diagnostic procedure capable of quantifying, monitoring, and recording changes in structure of enamel, dentin, and cementum.
A. The tip is a critical feature of the ECD. The tip is dimensionally designed to fit at the bottom of a pit or fissure and detect miniscule amounts of dentinal fluid that indicates caries activity. Excess use would cause the tip to dull and become misshaped which would cause inaccurate readings.
Q. Why is air drying the tooth necessary?
A. The ECD is designed to detect dentinal fluid at the bottom of a pit or fissure, allowing the ECD to complete an electrical circuit. Any saliva detected on the top of a tooth surface will also complete an electrical surface resulting in a false caries score.
Q. What is the maximum electrical current to the patient?
A. The ECD is powered by a 9 volt battery and it’s output is current limited to 10 micro amps [0.000010 amps ]. This is well below the threshold of perception of 1 milli amp [0.001 amp]. Please review all warnings, precautions and contraindications prior to use.
Q. What are the warnings, precautions and contraindications for the ECD?
Warnings and Precautions
Federal law restricts this device to sale by or on the order of a licensed dental practitioner.
This device should not be used on patients with cardiac pacemakers, internal defibrillators, intracorporeal fluid pumps or any other implantable electronic device.
Probe tip is sharp and can penetrate skin upon contact. Use common dental care practices when using the tip. Handle with care.
Use caution when inserting the Probe Tip into patient’s mouth.
Practice caution when using the ECD with hyperactive patients.
The ECD cannot be used to assess the following:
• Secondary caries
• The integrity of a restoration
• Dental root caries
• The depth of an excavation within a cavity preparation
• Interproximal caries
The ECD should not be used when the occlusal tooth surfaces are covered with an excess of plaque, tartar and/or other debris. Ensure these tooth surfaces are cleaned and excess debris removed.
A. Ortek Therapeutics, Inc. gives a limited two year warranty to all original purchasers for two years beginning from the date of purchase. During the warranty period, Ortek will repair or replace, at no charge, product or parts that proves defective because of faulty manufacture or material under normal use and maintenance.
This limited warranty does not cover any problems that are caused by conditions, malfunctions, or damage not resulting from defects in material or workmanship. Unauthorized alterations, wear and tear, abuse, improper use or failure to follow operating instructions supplied automatically voids all warranties. This limited warranty is not transferable.
In the event of a claim under this warranty, you must first contact us to determine the problem and the most appropriate solution for you. Customer must return product for repair or replacement, carefully packaged, with postage and shipping pre-paid.
Still Have Questions?Q. Where can I contact you for more information on the ECD?
A. Please contact us at 888-ECD-0023 (888-323-0023) or email us at firstname.lastname@example.org