Technical Description

Surveys have shown that about 8% of the population exhibit nocturnal bruxing behavior, or sleep bruxism (SB). Symptoms include severe tooth wear, temporomandibular joint disorder (TMD), morning headaches, disturbed sleep and daytime sleepiness. Few of these individuals are aware of, or seek treatment for SB, while others suffer the consequences indefinitely.
SB is characterized by the involuntary, nonfunctional grinding and/or clenching of the teeth during sleep. Patients are usually unaware of the condition, however others in the proximity may complain of loud grinding sounds produced by the friction of the teeth. SB is often related to malocclusion, mental anxiety, and neurological disorders; it may subside and reappear spontaneously.
Diagnosis of SB is best achieved by conducting an overnight sleep study that includes continuous monitoring of the electrical activity of the masseter muscles (EMG), which may show repeated bursts of activity that are not present in non-bruxers.
BiteStrip® is a low-cost, single use assessment and follow-up tool for SB. The device is used for determining the existence and severity of SB, for evaluating the short- and long-term efficacy of a treatment (such as a dental splint), and for titrating drug dosages.
The BiteStrip is a single-use disposable device designed as a front line screener for SB. It is a miniature electronic system comprising:
• Two pre-gelled skin EMG electrodes and an EMG amplifier, for acquiring nocturnal EMG signals from the masticatory muscles.
• A CPU for running real-time software that analyzes EMG strength patterns and for detecting and counting each bruxing episode.
• A permanent chemical display for presenting the study outcome in the morning.
• A lithium battery
• All the elements are integrated onto a single flexible substrate.
The patient cleans the BiteStrip’s display with the alcohol pad provided and applies the green sticker over the display area to activate the BiteStrip. The unit’s red light starts blinking, and then stops again a few seconds after the device is applied to the skin. The light will then blink with every EMG peak significantly stronger than the background signal.
In front of a mirror the patient should perform at least two maximal voluntary clenches (MVCs) during the first 30 minutes by biting on the wooden spatula provided. The light will then blink with every EMG peak (which is significantly stronger than the background signal). If the light does not blink with clenching the patient should carefully remove and reposition the BiteStrip. The two strongest EMG peaks detected during this period are used to establish the threshold, which is set at 30% of their average amplitude. It is therefore very important to make sure the patient performs this maneuver shortly after applying the device on the face in order to avoid picking up every small twitch during the night.
The BiteStrip counts each EMG peak stronger than the threshold for a period of up to six hours. Removing the BiteStrip in under four hours results in an error because four hours is considered the minimum period for a significant indication.
The study requires a minimum of 5 hours. An error will occur if the BiteStrip is removed earlier than 5 hours.
Ensure that the patient is informed to remove the sensor in the morning with the green sticker remaining intact. The number or letter on the display shows the intensity of the prevailing bruxism.
The patient should return the BiteStrip to their doctor as soon as possible for interpretation.

Reading the BiteStrip display
The display consists of a single digit or letter, which appears in black over the bright silver background at the end of the study.
The final score represents five possible test outcomes, based on the severity of the bruxism:
L – no or mild bruxism:  comparable to a sleep lab brux count of up to 30 over 5 hours
1 – mild:  comparable to a sleep lab brux count between 31 and 60 over 5 hours
2 – moderate:  comparable to a sleep lab brux count between 61 and 100 over 5 hours
3 – severe: comparable to a sleep lab brux count of more than 100 over 5 hours
E – error in study
Blank – no muscle activity has been sensored

The result is permanent and cannot be erased or altered.
You may keep the BiteStrip as a hard copy record of the test.
If necessary, place the orange Strip Reader Card over the display area to make reading easier.
If no number or letter can be seen on the display, a technical malfunction is suspected. The study must be repeated. The BiteStrip will be replaced under warranty.

Precautions and miscellaneous

- Instruct the patient to perform all steps promptly and consecutively, with no pause in between steps. It is very important to apply the strip on the face immediately after activation, followed by biting the spatula.

- Patients with full facial hair can not use the BiteStrip since adherence to the skin is critical to the success of the test.(Men should shave).

- Touching the display may cause the red light to turn on momentarily. This is not a problem, and the device can still be used.

- Ensure that the patient is informed to remove the sensor in the morning with the green sticker remaining intact. The patient should return the BiteStrip to their doctor as soon as possible for interpretation.

- The BiteStrip should be stored in a cool dry place until it is ready to be used.

- Review with the patient the correct way to apply the BiteStrip.

- Should the patient develop anything more than a mild skin rash or reaction at the site of attachment, instruct him or her to consult a dermatologist.

© 2006 by pixeltown OHG
BiteStrip® and SleepStrip are registered trademarks of S.L.P. Ltd.