Dental Tribune Asia Pacific No. 6, 2016

14 Dental Tribune Asia Pacific Edition | 6/2016 TRENDS & APPLICATIONS Intra-oral and peri-oral electronic devices An overview of current therapeutic and diagnostic systems By Dr Andy Wolff, Israel The functions and organ systems of the human body are, to a significant extent, controlled by electrical sig- nals that travel along the nerves. Electronic medical devices are aimed at controlling biological processes and treat disease by modulating these electrical impulses. These de- vices may assist in the therapy of conditions that are currently untreatable or resistant to other therapy methods. They may deliver treatment with greater precision and fewer side-effects than conven- tional pharmaceutical products do. In the last few decades, a vari- ety of wearable electronic medical devices have been introduced to the market. Examples of such de- vices include neuro-stimulators, cardiac pacemakers, implantable cardiac defibrillators, cochlear im- plants and retinal implants. These devices are used to address a vari- ety of conditions, such as brain disorders (including epilepsy, Par- kinson’s disease, traumatic brain injury, stroke, psychiatric disor- ders, etc.), chronic pain conditions (addressed through e.g. spinal cord stimulators), incontinence, cardio- vascular disorders (including heart failure, angina and peripheral vas- cular disease), deafness and blind- ness. A number of vital structures located in the oral cavity region are controlled by the nervous system, such as the salivary glands and the orofacial musculature. Given the largely proven diagnostic and ther- apeutic value of electronic devices, itissurprisingthatonlyafewintra- and peri-oral electronic medical devices have been released to the market. Moreover, in contrast to electronic devices that involve typ- ically invasive procedures, such as pacemakers and spinal cord stimu- lators, the placement and even the wearing of devices in the intra- and peri-oral region are not invasive. Nevertheless, it appears that the US Food and Drug Administra- tion (FDA) has considered for many years that electronic medical de- vices carry an increased risk if worn in the head and neck area, com- pared with other body areas, such as the limbs. Thus, electronic med- ical devices for the head and neck area are generally classified by the FDA as Class III devices, which are the highest risk devices and are, therefore, subject to the highest level of regulatory control. How- ever, recently the FDA has classified a small number of these types of devices as Class II devices, which are lower risk devices than Class III and require less regulatory control to provide reasonable assurance of the device’s safety and effective- ness. Nevertheless, those devices have to meet special controls, which are requirements intended to address the unique concerns of specific types of devices. Some ex- amples are as follows: • On 11 March 2014, the FDA al- lowed marketing of an electronic device as a preventative treat- ment for migraine headaches (Cefaly, CEFALY Technology). The portable, battery-powered pre- scription device resembles a plas- tic headband worn across the forehead and atop the ears.1 The user positions the device in the centre of the forehead, just above the eyes, using a self-adhesive electrode. The device applies an electrical current to the skin and underlying body tissue to stimu- late branches of the trigeminal nerve, which has been associated with migraine headaches. • On 8 July 2014, the FDA issued a final order classifying a trans- cranial magnetic stimulator for headache into Class II (special controls). The device delivers rap- idly alternating, or pulsed, mag- netic fields of brief duration that are externally directed at spa- tially discrete regions of the brain to induce electrical currents for the treatment of headache. • On 20 November 2015, the FDA issued a final order to reclassify an electrical salivary stimulation system (SaliPen, Saliwell) as a Class II (special controls) device. Previously, it was a Class III de- vice. This intra-oral device (more details later in the article) is re- stricted to patient use upon pre- scription of a dental practitioner or physician. • On 22 January 2016, the FDA an- nounced a proposed administra- tive order to reclassify cranial electrotherapy stimulator devices intended to treat insomnia and/ or anxiety, from Class III to Class II (special controls). Examples of three electronic intra- and peri-oral devices that are available are covered in the para- graphs that follow. 1. Intra-oral diagnostic device: Sensor for mandibular advancement devices TheraMon® (MC Technology) is a microchip specially designed to be embedded in removable ortho- donticanddentalsleepappliances.2 According to the manufacturer, the sensor reports the temperature of the device and its surrounding area. This enables assessment of whetherthesensor(embeddedinto the oral appliance) is being worn in the oral cavity or was outside of the mouth. The TheraMon® system consists of (a) a micro-sensor that measures and stores the temperature read- ings, that is wearing time data of the removable therapeutic device (Fig. 1).; (b) a reading station that reads the memory of the micro-sen- sor using radio-frequency identifica- tion technology and transfers the data to a computer via a USB cable (Fig. 2); and (c) assessment software that represents the wearing time in a diagram. TheraMon® is a Class I med- ical product (lowest level of risk) that does not claim any medical, thera- peutic or diagnostic functionality. Sensors like TheraMon® can be implemented in mandibular ad- vancement devices (MADs), which are increasingly being prescribed as an alternative to the use of continu- ous positive airway pressure (CPAP) systems in the treatment of ob- structive sleep apnoea. Studies have shown that MADs are preferred by patients and, thus, compliance with treatment may be greater than for CPAP. However, compliance with the treatment can be better measured in the CPAP system, as the built-in pro- cessor allows follow-up of the actual hours of use of the mask. In contrast, conventional MADs lack this control system and, thus, objective verifica- tion of compliance is not possible. Therefore, a microchip for thermal sensing that is inserted into a MAD can provide this missing ability to measure compliance objectively. In a blind prospective clinical study of three months’ duration, the safety and feasibility of objec- tive measurement of compliance with MAD wearing was evaluated.3 A Lirón MAD4 (Fig. 3) equipped with a temperature micro-sensor was Fig. 1: The TheraMon® microsensor and a removable device to which it will be attached.—Fig. 2: TheraMon® reading station and microsensor, with a removable intraoral device.—Fig. 3: Lirón MAD. 1 2 3 Fig. 4: SaliPen device in place, reaching the lingual nerve region bilaterally.—Fig. 5: SaliPen device.—Fig. 6: SaliPen usage. 4 5 6 “...it is surprising that only a few intra- and peri-oral electronic medical devices have been released to the market.” 123 456

Dental Tribune Asia Pacific No. 6, 2016

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