Bruxane 2 Go Dental Splint

When a certain chewing pressure is applied, a vibration is triggered. This can be heard as a buzzing sound through bone conduction, thus engaging two senses. Through the bruXane biofeedback, the patient is subconsciously conditioned to stop the incorrect action, which is teeth grinding.

Stress/bruXTracker: With bruXane personal "data", the recorded grinding data can be transferred to a computer and analyzed using software.

Your bruXane carries the CE marking, meets the requirements (Declaration of Conformity) as a medical device in the EU, and has been tested according to the specifications of the EMC Directive (Electromagnetic Compatibility). Appropriate safety tests have been conducted and passed.

There is an indicator paper inside bruXane that turns red when moisture (saliva) penetrates. Do not wear your bruXane if this happens.

bruXane 2go is made of medically approved silicone.

The functionality of bruXane is substantiated: Several independent studies have shown that the principles used by bruXane (combination of occlusal splint and biofeedback) reduce teeth grinding. The efficacy of bruXane is clinically proven. The clinical study from the University of Munich can be found here: rdcu.be/b4mIP

The S3 guideline for bruxism also recommends biofeedback!

Improvements in subsequent symptoms can be felt with bruXane after just a few nights. A reduction in the number and duration of grinding events can typically be achieved immediately. Here you can find an example graph of the improvement without and with biofeedback.

Patients also report a rapid improvement in subsequent symptoms after just a few nights.

The clinical study from Ludwig Maximilian University of Munich has confirmed that the sleep quality of patients is not disturbed by bruXane. A few patients occasionally wake up in the first few nights due to the biofeedback. Overall, the sleep quality is improved due to reduced grinding, so that patients wake up more rested and refreshed the next day.

bruXane 2go is a one-size-fits-all device that may not offer a perfect fit. However, the soft silicone material is highly adaptable. With a wire reinforcement in the front connector, one can pre-bend bruXane 2go to adjust it slightly to individual needs. You can wear bruXane 2go on either the upper or lower jaw. If sensitive spots develop, you should switch between the upper and lower jaw as needed. Placing the upper or lower lip over this bridge can provide additional support. If bruXane 2go falls out of the mouth during the night, it is not a problem. Even a few hours of biofeedback can lead to a noticeable improvement!

The potential for rapid improvement of subsequent symptoms, even after just a few nights, can make any discomfort seem insignificant. This quote from a patient is quite typical: "The adjustment period was really very short, which I couldn't imagine at the beginning. On the contrary, I miss something if I 'forget' to put it [the bruXane] on in the evening." bruXane personal is made individually for each patient and therefore offers a more comfortable fit.

The bruXane biofeedback is only perceptible to the wearer. The bed partner is not disturbed by the vibration and the quiet humming sound. This was an important concern for us in the development of bruXane. Your partner will be pleased if you no longer grind your teeth loudly ;-)

bruXane personal is made from commercially available and approved splint material. It is based on methacrylates; free from softeners, plasticizers, and Bisphenol A (BPA.)

bruXane 2go is made from medically approved silicone.

It is possible to experience increased salivation during the first few nights. According to experience, this usually decreases after some time.

Due to a possibly increased mouth opening, it can happen that the lips may dry out or there may be an increased flow of saliva. Typically, this subsides after a few nights.

Mit einem Implantat geht der natürliche Nerv (Rezeptor) verloren, dadurch spürt man den entstehenden Druck nicht mehr. bruXane macht durch das Biofeedback auf das Knirschen aufmerksam.

bruXane reduziert nachweislich die Anzahl und Dauer der Knirsch-Ereignisse und verringert somit die Belastung auf Implantate und Restaurationen. Die Meinung vieler Fachleute ist, dass man prinzipiell zum Schutz von Implantaten und hochwertigen Restaurationen zur Prophylaxe bruXane verwenden sollte. bruXane kann somit Implantate und Restaurationen schützen.

The use of bruXane leads to a reduction in grinding activity in many patients within a few nights, which is composed of the duration of individual grinding events (bursts) and the number of these bursts. These results demonstrate an immediate learning effect.

The results show a high level of patient satisfaction, as wearing bruXane eliminates subsequent symptoms. Many patients continue to use bruXane as long as they experience pain symptoms; once these symptoms are gone, they discontinue use and revert to bruXane as needed.

Patient experiences over a period of more than 2 years show no habituation effect, and our patients consistently confirm this.

As already proven in the clinical study, the effectiveness of bruXane is guaranteed. It should be noted that alcohol, sedatives/drugs, and medications can influence grinding activity as well as the response to the biofeedback.

The intake of medications, sedatives/drugs, and alcohol can affect a person's responsiveness and also their teeth grinding behavior. Grinding behavior can be intensified by the intake of the above-mentioned substances. The data evaluated from bruXane have shown that the reactions to the biofeedback were diminished and delayed under these influences; therefore, the effect of the biofeedback is limited when taking these substances. This may lead to increased stress on the material. There can be no guarantee against biting through the splint material.

The bruXane 2 go model is intended for an introduction and familiarization with biofeedback. Therefore, we recommend a wearing period of about 8 weeks. The goal was to provide a cost-effective biofeedback device, which is why we use a battery and not a rechargeable battery with a charger. For longer use, we recommend the individually adapted bruXane personal, which is operated with a rechargeable battery.

The one-size-fits-all bruXane 2go naturally does not cover all teeth evenly. We recommend a wearing period of approximately 8 weeks for bruXane 2go. Please discuss a longer wearing time with your dentist.

The built-in battery has a limited lifespan (with average grinding activity of about 100 times per night = approximately 8 weeks).

bruXane 2go is designed for quick pain relief and for testing the biofeedback. If you have noticed a relief in your pain symptoms, then we recommend switching to bruXane personal.

bruXane 2go is industrially manufactured and cannot be adjusted. bruXane personal, on the other hand, is custom-made for you in a dental laboratory. The standard trigger pressure (from which biting pressure the biofeedback starts) is suitable for most patients but can be adjusted upon request if necessary.

The indicator paper in the bruXane indicates the presence of moisture (saliva) with a red
discoloration. Once the indicator paper turns red, stop using your bruXane. For warranty
claims, please contact service@bruXane.com.au

bruXane 2go has a specified durability of max. 8 weeks. In individual cases, exceptions may be made.

The battery life is approximately 8 weeks with about 100 grinding events per night. With fewer grinding events, bruXane 2go lasts accordingly longer, etc. If there is a defect within the first few weeks, please contact service@bruXane.com.au

bruXane is suitable for teeth clenching and teeth grinding.

In case of a complaint regarding bruXane Personal, please contact service@bruXane.com.au

The indicator paper indicates the presence of moisture (saliva). Please discontinue use of bruXane 2go and contact service@bruXane.com.au regarding a complaint. The battery of bruXane 2go cannot leak; it is a solid-state battery.

It shines like moisture. However, it is silicone.

Our experience is that if you only wear bruXane at night, you can also learn not to grind during the day. The body becomes aware of the grinding, so it can refrain from doing so. These are our experiences. Of course, you can also wear bruXane during the day if the situation allows and the wearing time does not exceed 11 hours. Please observe exclusion criteria in the instructions for use.

As it is one-size-fits-all, bruXane 2go is not individually tailored. However, due to its flexible soft silicone material, bruXane 2go is adaptable and suitable for different jaw sizes. With a wire reinforcement in the front connecting piece, you can slightly adjust bruXane 2go to meet individual needs by bending it forward. You can wear bruXane 2go on the upper or lower jaw. Placing the upper or lower lip over this bridge provides additional support. If bruXane 2go falls out of the mouth at night, it is not a problem, as just a few hours of biofeedback lead to noticeable improvement! For extended use, we recommend the individually made bruXane personal.

There may be increased saliva flow during the first few nights, especially if one is not accustomed to wearing a dental guard. This typically subsides after a few nights.

It may lead to a dry mouth in the first few nights, especially if one is not accustomed to wearing a dental guard. This typically subsides after a few nights.

With bruXane 2go, not all teeth are evenly covered. If you wish to wear your bruXane 2go for a longer period, please discuss this with your dentist. The battery life is approximately 8 weeks with about 100 grinding events per night. For longer wear, we recommend the individually made bruXane personal tailored to you.

bruXane bears the CE marking, meets the requirements (Declaration of Conformity) as a medical device in the EU, and has been tested according to the specifications of the EMC Directive (Electromagnetic Compatibility). Our suppliers are also committed to complying with the Medical Devices Act.

The entire electronics are hermetically sealed. There is an indicator paper in bruXane which turns red in case of moisture penetration (saliva). Do not wear your bruXane if this occurs.

Rinse bruXane under cold or lukewarm, clear water, optionally using a small amount of liquid soap and a soft toothbrush, then rinse thoroughly with clear water. (No soap taste remains) Afterwards, dry well and place it in the storage box/charging box.

You can read the successful clinical study of bruXane at the following link rdcu.be/b4mIP. This demonstrates the effectiveness and efficacy of bruXane. The biofeedback must be effectively implemented in bruXane for it to be activated. Please verify this with your dentist. The response to biofeedback is reduced by drugs, alcohol, and medications, which should be avoided as much as possible. Similarly, these substances are suspected to increase bruxism activity.

bruXane is made of soft splint material, so it is not possible to correct the position of the jaw/teeth.

With bruXane 2go, you have the opportunity to test the bruXane biofeedback before deciding on an individually made bruXane personal.

bruXane 2go has an inner dimension of 10 mm. If the tooth with the brackets is less than 10 mm, then it will work.

bruXane 2go has the following dimensions: approximately 2.3 x 2.4 x 8.5 cm (H x W x L).

bruXane personal is custom-made for you.

In a 'standard bite,' the sensors of bruXane 2go are located approximately in the area of the 4th/5th (back) teeth. If you have concerns about not having enough tooth structure, please consult your dentist.

bruXane personal is custom-made for you based on your existing teeth.

The sensors are located on both sides of the bruXane 2go and detect chewing pressure on both sides. A vibration motor is located on one side of the bruXane 2go, but the vibration is perceptible throughout the oral cavity due to bone conduction, and the buzzing sound is audible. Apply strong pressure simultaneously from top and bottom to the individual sensor areas (oval areas on the chewing surface).

If you feel that it is not vibrating, please perform the following test: place the left sensor area (white pad) on a table edge. Now press with a hard, rounded object on the sensor area. You should now feel a vibration.

To ensure functionality, please charge your bruXane personal daily. The battery is charged wirelessly.

When the charging process has just been completed, bruXane personal may still be slightly warm. Temperatures slightly above body temperature are normal during active charging. It's best to let it rest for a short moment after charging.

To prevent material overuse, please note the following:

• Alcohol, drugs, and medication slow down the body's response to biofeedback and
  can lead to increased grinding activity, which may result in premature material wear.
• 
  Post-processing of the foil material by the dentist or patient is not possible.

When registering your bruXane personal, please close the lid of the charging box to eliminate external light sources. Foreign light exposure could interfere with the IR communication between the computer and the charging box. If bruXane personal is not recognized, change the position of bruXane.

Our software does not need to be installed. You can download the software from the download directory. Further information can be found in the software manual for patients/dentists.

You can find the software manual at www.bruXane.com.au/downloads.

The bruXane personal must be charged until the LED on the bruXane is constantly turquoise. Typically, this takes a few hours, but if the battery has been deeply discharged, it may take longer.

bruXane personal is ready for use once it is fully charged (see user manual).

Exclusion criteria

Carriers of pacemakers/and other implants (dental implants excluded)/pregnantwomen/children/ etc.

Connect the charging box to a free USB port on your computer or to an electrical outlet using the supplied USB power adapter. The turquoise LED lights up.

Place your bruXane with the bruXane logo facing down on the plateau of the open charging box. Pay attention to the marked orientation information on the charging surface.

Once the charging box recognizes the bruXane, the LED on the charging box flashes (indicating the so-called handshake/established connection), and the LED on the bruXane indicates the charging status.

Detailed information can be found in the supplied user manual and in the software manual.

Storage space for approximately 2000 teeth grinding events. At 100 teeth grinding events per day, this is sufficient for approximately 2 weeks. Once the storage space is full, old teeth grinding events will be overwritten by the new ones. To avoid losing old data, it is recommended to read out the bruXane personal at least once a week. If the battery is empty, a complete data readout is not possible. For the most up-to-date information, please refer to the software manual. (https://www.bruXane.com.au/downloads)