Response to the FDA Concerns Regarding AGGA and other Similar Devices

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Released March 31, 2023

Over the many years of treating TMJ disorders, my office has realized a couple of things: Do not use appliance therapy that is fixed or cemented in the mouth and using the AGGA or similar devices like FAGGA, MARA, ARA, FORA and RPE may not be wise when it comes to achieving the goal of palatal expansion and/or moving the upper jaw forward. The first reason, and the biggest, was the decrease of effective oral care. The reason for the other appliances is a big one.  The bones of an adult skull will simply not move 10+mm forward as some AGGA practitioners claim. The only way to achieve such a distance is to surgically reposition the upper jaw and our office does not recommend that. The reason is the nerves and blood vessels may be damaged in the process. The only time MMA (Maxillary and Mandibular Advancement) is recommended is with hopeless apnea cases where all other modalities have failed.

I have personally seen a number of AGGA type cases over the years and have observed that most of them tip the upper teeth forward so quickly that the teeth will come out of the bone, leaving them mobile in many cases. The jawbone itself does not remodel and come forward as the advertisers indicate. This has been the problem all along: too much force too fast in adult cases. In my office we have never used and never will use the AGGA or similar device. This is why my office has also banned the use of RPEs (Rapid Palatal Expanders). When expanding the palate rapidly, the same effect can occur, whether in children or adults. If a palatal expander is ever used, it must be done slowly and carefully, regardless of the patient being a child or an adult.

A better device is called the ALF (Alternative Lightwire Functional) developed by Dr. Darick Nordstrom many years ago. With children the ALF provides expansion for crowded cases, but perhaps more importantly, it gently opens up the bones to provide relief from head pressure and pain. With adults, the ALF is not a palatal expander, but more of a support appliance. The analogy I use is that it is like an arch support in your shoe; providing support that has been lacking. It is quite the opposite of a forceful AGGA. To achieve relief from your TMD symptoms such force is neither logical nor necessary.

The ALF was developed to help avoid extraction of permanent teeth like bicuspids. When teeth are extracted, this can collapse the airway and change the position of the cervical spine (the neck). Using the gentle approach of the ALF can open up narrow arches in children and avoid the extractions which used to be the ‘norm’ for orthodontists. So in lieu of even the palatal expander, the ALF offers a better approach.

When it comes to patient care and the decisions you make for your family it is important to keep in mind that the FDA recommendations regarding AGGA are quite clear, and I wholeheartedly agree that the AGGA and similar devices have the potential to damage the jaws and the teeth. Ask your dental provider about the FDA concerns and be aware what it means to wear such devices. If you have any questions about these devices or your dental health, we welcome you to call our team in Falls Church, Virginia at 703-821-1103. Dr. Jeffrey Brown is ready to help you with all aspects of your smile!