Patients of all ages, children through adults, have benefited from the use of BiteBuoy™. However, we have found that children aged 2 to 12 years have benefited the most, given the fact that they are more likely to bite themselves based on statistical evidence. On average, children less than 12 years of age are about twice as likely to bite themselves after dental treatment as persons 12 years of age or older.

Yes, it is safe for latex-allergic patients. BiteBuoy™ is made of a non-Latex material.

There is always some risk of potential liability for the use of any product when providing dental care, and BiteBuoy is no different than any other product in this respect. Nonetheless, when used properly and as intended, the BiteBuoy™ assists the dental practitioner in the treatment of their patients in much the same fashion as the athletic mouth guard, the rubber dam, or, more pertinently, a piece of gauze or cotton roll inserted between the teeth to prevent biting after dental treatment. Some practitioners have, however, expressed the concern that the patient may swallow the BiteBuoy™. Although ingestion or aspiration of the mouth guard always remains possible, we believe that the risk of this occurrence is comparable to the risk involved in having a patient swallow an athletic mouth guard during a sporting event. Also, if used when fitted with a tether to a patient’s clothing, the likelihood of ingesting or aspirating the BiteBuoy™ further decreases, and such usage presents significantly less risk than use of an untethered cotton roll or piece of gauze. Given the size and shape of the BiteBuoy™ and the fact that it can be tethered to a patient’s clothing, we believe that the risk of ingestion or aspiration is most similar to that of a tethered athletic mouth guard or a tethered pacifier that is clipped to a child’s clothing.

Additionally, in the event Post-Anesthetic Oral Soft Tissue Protective Devices become a “Standard of Care” following dental treatment, a further legal consideration is any potential negligence and/or liability which may arise for breach of care when the BiteBuoy mouth guard is not used and a patient sustains a bite injury after dental treatment or application of local anesthetic.

There are always children who will refuse to do anything that is asked of them, even when given a good explanation. However, these children aside, we have found that the vast majority of children who initially refuse to wear BiteBuoy™ respond very well to a Tell-Show-Do (TSD). We simply explain the purpose of the mouth guard while holding it out in front of them (after it is molded to their teeth) and say something along the lines of:

“This is a mouth guard that has been molded to fit around your teeth on this side (pointing to the side that is getting numb), where your teeth are going to be sleepy, so that we can work on them. Your lip and cheek (and tongue) are going to get sleepy too. We do not want you to bite your lip or your cheek (or your tongue) after they are asleep from the sleepy juice. So, we are going to use this mouth guard to protect them from getting hurt by your teeth because you can bite yourself after the sleepy juice has started working. This (mouth guard) is not for you to ‘CHEW’ on. You need to ‘HOLD’ it in place, in its ‘comfortable position’ by keeping your teeth together and biting down on it gently. It would be best if you did not talk while it is in place. If you do need to talk to us when it is in your mouth, then you will need to talk by keeping your teeth together and ‘TALKING LIKE THIS’ (demonstrating that talking with the teeth together can be done and what it looks like to the child).”

Most children respond very nicely and find that it is a fun new challenge to talk with their teeth together.

This is not absolutely necessary, but it is helpful to maintain the best fit and the best possible protection.

BiteBuoy™ will become moldable at about 150°F. Since the temperature of the water it is inserted into will vary (even when from the same hot water tap), the easiest way to determine that it has reached this temperature is to observe the vertical side walls/flanges of the mouth guard for changes in their shape. When the mouth guard material reaches the desired level of temperature for optimal molding, the outer edges will start to shift and curve towards the lingual aspect of the mouth guard. Once this shifting begins, the mouth guard is hot enough for proper molding to the mouth and should be removed from the water, even if the time in the water is less than 10 seconds. However, this usually requires at least 10 seconds to occur. If this does not occur within 30 seconds, then the water is probably not hot enough to mold around the patient’s teeth.

The best results can be obtained by immersing the mouth guard for 10 – 15 seconds in water heated from a coffee maker. Coffee makers are, more or less, standardized and are designed to heat water at a consistent temperature; thus, they deliver the best results without causing the mouth guard to become deformed or making the material so hot that it would cause burning of the oral mucosa. Water heated in a microwave oven or through a hot water tap can be done, but is NOT RECOMMENDED, because they can deliver inconsistent results (due to the variations that are inherent to these heating methods), which require adjustments in the amount of time that the mouth guard remains immersed. If the water is too hot, the mouth guard can become deformed if left in the water too long. It is important to avoid deformation of the mouth guard. So, DO NOT OVERHEAT the material.

Extremely well. In-house surveys of patients and parents are extremely supportive of the device and appreciate the fact that we’ve taken their preventative care to the next level.

It’s a little too early to say exactly, but we anticipate the price to clinicians will be less than $2. Retail pricing is at the discretion of each practice. Patients are currently willing to pay between $5 and $10 with minimal objection, other than that many patients believe it should be covered by insurance.

We are preparing a CDT Code Request to the ADA and will provide it upon receipt of approval. Until then, clinicians may use their own professional judgment to determine the most appropriate pricing, coding, and documentation for their practice.

At present, there is no CDT Code for the “prevention of self-induced injury following the administration of local anesthetic” (by a dental professional). Obviously, we think this should change, and there should be a code for use by dental professionals who have concerns about their patients’ condition—concerns that extend beyond the treatment appointment—and want to proactively address this concern.

Some of the issues are that, in the recent past, there have only been injectable reversal agents to address the issue of post-operative numbness and any associated self-induced trauma. One would think that this would warrant a new CDT code. Yet it seems that single-remedy CDT codes are generally not favored for approval. Now that BiteBuoy™ is being introduced, we hope to change that.

We are preparing a CDT Code Request to the ADA and will provide it upon receipt of approval. Until then, clinicians may use their own professional judgment to determine the most appropriate coding and documentation for their practice.

Not at this point, but perhaps in the future. While BiteBuoy™ is sized to fit patients with second adult molars (so that older patients with disabilities can optimally benefit from the protection it provides), the mouth guard can easily be trimmed to fit even very small mouths.

To adjust the size, trim away excess distal material using scissors (suture or crown and bridge scissors). This is most easily accomplished by making aligned cuts in the protective side walls on both the buccal and lingual surfaces toward the biting plane, then cutting across the biting plane to remove the excess distal portion, which can then be discarded.

This trimming may be performed either before, or after fitting should it become apparent that the mouth guard is slightly too long distally.