BiteStrip™ introduction

Main Sleep Disorders Overview Sleep apnea Stops in respiration during sleep PLMS Involuntary limb movements during sleep Insomnia Problem in initiating and/or maintaining sleep Bruxism Nigh time teeth grinding and clenching Narcolepsy Sudden uncontrolled sleep spells Bruxism is a very common sleep disorder. Unlike other sleep disorders, however, Bruxism is not handled by the sleep community because it is automatically calcified as a dental problem. This situation results in very little awareness, and very low attention by the dentins, since it is not in his main line of work. Our aim in designing the BiteStrip was to provide the dentist a very simple tool which will enable him to get accurate Bruxism indication without having to invest in instrumentation, further education, or disrupt his treatment routine. With the BiteStrip every dentist can get immediate indication of the existence and severity of Bruxism, and act accordingly for the good of his patient.

The Sleep lab EEG EOG EMG (Bruxism) ECG Effort Snore Flow Pulse oximetry Leg movement Esophageal pressure Others (NPT, Video) Being a sleep disorder, Bruxism “gold standard” is measurement of night-time jaw muscles contractions during sleep, preferably in the sleep lab. While many other physiological signals are also being monitored, ElectroMyoGraphic (EMG - muscle generated electrical signals) are also reordered in the sleep analysis system. In the morning, the sleep tech reviews the record and counts number of EMG bursts which are the tell-tale sign of forceful muscle contractions. Other channels of information allow the technician to tell at what sleep stage Bruxism was measured, at what body position, and if it is related to other disorders. Still, the diagnosis whether Bruxism exists or not is only a factor of the number of EMG bursts measured over the night.

What is Bruxism Bruxism is the forceful clenching or grinding together of the teeth Bruxism is subconscious behavior. The patient is usually unaware of this habit Prevalence is high (10-25%*), and decreases with age Patients sometimes grind much harder while asleep than they can while awake Often referred by bed-partner Different studies give different numbers to the percentage of people who brux, but almost all agree that: Bruxism is mainly evident in young people, and decreases with age. At least 10% of people brux on a regular basis, and many more brux occasionally. Forces generated by the bruxer on the teeth are very strong, and are sometimes much stronger than any force the patient can generate while awake. This is probably due toe the fact that the sleeper is insensitive to the pain of clenching. Usually the patient is not aware of his condition. Upon careful questioning the patient was describe several signs associated with Bruxism like stiff jaw muscles in the morning, sensitive teeth, TMJ pain, “click” in the jaw when opening the mouth in the morning and others. It is usually the bed-partner that draws the patient’s attention to the disorder, hearing grinding noises. This doesn’t work with clenchers, who are silent. * Cranio. 2003 Apr;21(2):144-51. Melis M, Abou-Atme YS. Prevalence of bruxism awareness in a Sardinian population. and other sources.

Bruxism Damage Enamel erosion of teeth chewing surfaces. May result in fractured teeth and fillings Damage to tempomandibular joints, leading to TMJ syndrome Damage to gums and other oral structures Sore facial muscles, headaches, and migraines Damage to reconstructive dental work like crowns, veneers and bridges. Low sleep efficiency, day time sleepiness The huge forces generated by the bruxes can break anything in the mouth, from other teeth to any type of dental work to other oral device (mainly of the type used to treat sleep apnea). With these patients diagnosing the condition is simple. It is the moderate and mild patients who may suffer from the disorder for years, with sensitive teeth, TMK pains, migraines and other discomforts, until at last damage to the tooth is so severe that the dentist can convince them to use a night-guard.

Some horrible pictures Bruxism is usually “diagnosed” by dentists, based on tooth attrition status. New studies show little correlation between current tooth attrition and actual Bruxism, demonstrated by EMG recordings. Sleep Bruxism (SB) is characterized by involuntary grinding and clenching of teeth during sleep. The movements are rhythmic or tonic contractions of the masseter and other jaw muscles. Patients are usually unaware of the condition, and bed partners or roommates usually complain of the unpleasant noise. Symptoms include abnormal wearing of teeth, temporomandibular joint (TMJ) dysfunction or pain, chewing difficulties, headaches and daytime sleepiness. The prevalence of SB is at least 8% in the adult population. SB is diagnosed based on clinical examination of the teeth, complaints of jaw and masticatory pain, and subjective reports by the bed partner or family member, of the grinding and clenching noise. Currently there is no “gold standard” for a definitive, objective diagnosis, but sleep lab overnight recording of masetter EMG is considered the best alternative. Due to high costs of PSG in-lab recordings, patients suspected of SB are not routinely referred for such a study.

Sleep lab Bruxism monitoring Monitor EMG activity of jaw muscles Count events stronger than 20-30% MVC*, longer than 0.5sec Jaw muscles contraction Bruxism =>5 events/hour Jaw muscles EMG trace     What causes the bruxism to occur? The cause of bruxism is multifactorial. This mandibular parafunctional behavior has been observed to be related to periods of high emotional and physical stress, as well as the anticipation of stress. Bruxist activity is aggravated by the consumption of alcohol, as well as some types of medications. Bruxism has also been observed in studies of individuals with disturbances of the central nervous system. *(Maximal Voluntary Clench)

The BiteStrip 2 EMG electrodes (on back) Indicator light Miniature 3V lithium battery CPU and electronics Indicator light Permanent electro-chemical display Methods: The BiteStrip is a miniature single-use electronic device designed as a front line screener for bruxism. It is comprised of two EMG electrodes and an amplifier to acquire masticatory muscle EMG signals which are in the mV range, a CPU with real time software running a million operations per second, which detects and analyses EMG patterns by comparing the amplitude of each burst to the predetermined threshold, a permanent electro-chemical display which presents the outcome in the morning, a light emitting diode (LED) and a 3V lithium battery. All elements are integrated on a single flexible substrate. Unlike any system on the market, the BiteStrip analyses the EMG signal in real time, instead of collecting the data fro downloading and processing the following morning. This eliminates the need to purchase specific hardware and software, handle logistics of loaning and retreating the machines form the patients and the work involved in the downloading and processing of the data.

BiteStrip tells me you need a nightguard! Operating principle BiteStrip tells me you need a nightguard! BiteStrip is a complete EMG recorder. Comprising two EMG electrodes, an amplifier, real-time data acquisition hardware and analysis software and a permanent display. Each bruxism episode is counted in real time. This count is used to calculate a bruxism severity index, which is presented on the digital display in the morning. * The BiteStrip: A Novel Screener for Sleep Bruxism Hadas N, Shochat T, Molotzky A, Lavie P Presented at the Chicago APSS meeting, 2001

How BiteStrip scores an event Only EMG bursts stronger than threshold are counted* Threshold is updated to 30% of MVC* in awake Event = EMG > 30% of MVC for more than 0.5 sec. Long events – Additional events are added for every 1.5 second in clench. *Voluntary Maximal Clench

BiteStrip operation Must clean display before study for good readability Activated by attaching green sticker on display, light blinks to mark proper activation During first 20 minutes, light blinks with each clench. Perform two MVC to calibrate the threshold. After 20 minutes flashing stops and actual study begins (assume patient is already asleep) Must be on face at least 5 hours for a valid study When removed, light will turn ON to indicate end of study After 60 minutes display can be read after removing the green sticker, do not remove sticker sooner

BiteStrip Operating instructions General: The BiteStrip® should be applied prior to “lights off”, just before lying in bed. With reference to the pictures in the slide 1. Remove BiteStrip® and green sticker from wrapper, and alcohol preps from box. 2. Remove one alcohol prep pad from its bag, and firmly wipe display area (see arrow in figure 1). 3. Peel green sticker off white protective paper and attach it to the display area of the BiteStrip®, as shown in figure 2. A red light will blink underneath the white cover of the BiteStrip®, indicating that the sticker is properly placed (figure 3). 4. With hand placed on left cheek, clench teeth tightly together to find the jaw muscle that contracts. This is the proper site for attaching the BiteStrip®. Clean site with second alcohol pad and let dry. 5. Remove protective white paper off the back of the BiteStrip®, and attach to cheek firmly as seen in figure 4. Red light will turn OFF after a few seconds. 6. Facing a mirror, clench you teeth as hard as you can for 2-3 seconds and then relax. Repeat 3 more times. Red light will blink during each clench. 7. Have a good night’s sleep! 8. Upon awakening, remove BiteStrip® from face. Shortly after removal, the red light will turn ON. 9. Return BiteStrip® to your dentist/physician for interpretation of the results.

BiteStrip study timeline Light flashes until placed on face Light turns ON when removed off face Attach green sticker Activation Remove green sticker Read score After 20’, Automatically begin study Remove from face First 20‘ Perform two MVC to calibrate threshold. Light flashes with each clench. Last 30’ Calculate score and activate display 5-6 hours, but not more than 12 count clenches and grinds stronger than 30% of MVC

BiteStrip readout Healthy subject – less than 40 events Mild Bruxism – 41 to 74 events Moderate Bruxism – 75 to 124 events Reading the BiteStrip display is very easy, just peel off the green sticker to read the number. It is better to do this as soon as possible, but not sooner than 1 hour after the study has ended. The display is permanent, and the device can be filed as the medical reference fro the study. In some cases you may use the yellow “strip reader” to increase display visibility. Simply put the card over the display to make reading easier. If you are not sure the first time, you can always run a second study. Studies show that especially with mild cases there may be significant night to night variability of the same patient. This is especially true if the patient drinks, smokes or has trouble sleeping. Severe Bruxism –more than 125 events Error – too short study or other problems.

BiteStrip performance Spearman’s rho Mann Whitney Right Left r=0.93, p<0.001 ns 146.2 (157.8) 156.9 (158.7) EMG r=0.83, p<0.01 130.6 (110.3) 144.2 (114.8) BiteStrip

BiteStrip highlights Only EMG recorder designed specifically for Bruxism studies. At home study – natural sleeping environment Good correlation with gold-standard results Low cost – may be repeated as necessary Easy to use, disposable No additional equipment necessary Instant results, small, low weight Permanent result – save as hard copy of study

BiteStrip Competition Questionnaires/Physical examination Bruxguard reusable biofeedback device Ambulatory sleep studies In-lab sleep study Several papers published in peer-reviewed magazines clearly prove that examining the patient’s teeth for signs of wear “which are characteristic of bruxism” is a very unreliable way of diagnosing the condition. This was demonstrated both by showing very little agreement between dentists examining the same patient, and by very low correlation with sleep lab EMG recordings. The Bruxguard is a new device which is aimed specifically at bio-feedback therapy of bruxism by sounding a buzzer every time the patient brux. A built-in counter counts number of events detected in use. The device has not been clinically validated, and does not account for long clenches, nor is it calibrated to the individual patient. In-lab sleep studies are the best diagnosis option, but even an ambulatory study costs about $500 (in the USA) so of course this is not an option. In-lab studies are even more expensive.

BiteStrip applications (1) Dentists: Check/confirm need for night-guard Help plan/price reconstructive work Convince patient of need for dental protection Dental-sleep: help decide on best oral appliance for sleep apnea therapy. Sleep labs: rule-out Bruxism due to CPAP therapy GP: Differential diagnosis for non-specific orofacial pain/ headaches/ migraines Dental surgeons: Screening for bruxism before implants

BiteStrip markets (2) Research: epidemiological studies Psychologists: screening for Bruxism as part of anti-stress therapy TMJ experts: Differential diagnosis in TMJ patients CPAP users: rule-out Bruxism due to CPAP therapy Pain clinics: Differential diagnosis in migraine/non-specific orofacial pain patients.

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