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All About the AGGA and More! Adult Orthodontics Considerations - Part One
On March 1, 2023, CBS News with Kaiser Health News published an exposé on the Anterior Growth Guidance Appliance (AGGA). Numerous complaints that AGGA treatment damaged patient's mouths resulted in over 20 lawsuits.
What is this appliance and how did this come to be? I delved into the AGGA in order to have a better understanding, in addition to other newer and traditional orthodontic appliances and treatments. It is a lot of material, so it will be covered in four parts.
I had seen the AGGA before online, about two or three years ago at first. I read about it in some sleep apnea support groups that I joined. I remember that I was surprised that I had never heard or learned about it in my training. I searched online to learn more, and I found minimal information about the appliance on a few dentists' websites. I remember I searched for it on PubMed and couldn't find anything. Many patients on forums seemed convinced that this and other similar devices were the way to go, though.
I have been meaning to write about the AGGA and other appliances for a long time. In the past I was concerned that it was too controversial and that there wasn't enough information. The CBS report and FDA briefing have empowered me and have offered credence.
A follow-up report was presented on March 15, 2023, where CBS looked into why the AGGA was not FDA approved. They determined that the founders had considered the appliance to operate like a retainer (which seemingly contradicts their selling points of the appliance itself, as you will read more about shortly). The CBS report concluded that there was no communication between the founder of AGGA and the FDA prior to making the AGGA or when they began selling it to the public.
Furthermore, the CBS reporters discovered that the AGGA is now under a new name and continues to being marketed as the Osseo-Restoration Appliance.
As per their 3/15/2023 report:
“The AGGA, which was recently rebranded as the Osseo-Restoration Appliance, uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. Galella [the founder of the AGGA] has said pressure from the device causes an adult's jaw to "remodel" forward, which he described, in training footage produced in discovery in an AGGA lawsuit, as the key to "curing" patients and making them more beautiful. ‘You can sell good health. You can help people and at the same time you're going to make a wheelbarrow full of money,’ Galella tells dentists in the video footage. ‘And it's all OK, and it's all fair. We're not cheating anybody and we're not being greedy, but that just comes with the territory.’”
This is what the FDA had to say on March 30, 2023:
“The U.S. Food and Drug Administration (FDA) is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions.
The devices of concern include:
Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance Appliance (FAGGA),
Anterior Remodeling Appliance (ARA) and Fixed Anterior Remodeling Appliance (FARA),
Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA), and
Any other similar device types.
The FDA is aware of these devices being used to treat conditions such as obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD) of the jaw, and to remodel the jaw in adults. However, the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by the FDA.
Palatal expanders are dental devices typically used to widen the roof of the mouth (palate) to make room for crowded teeth. Palatal expanders are generally used during orthodontic treatment for children and adolescents whose upper jaw bones are not yet fused. At this time, the FDA is not aware of safety concerns related to orthodontic use of palatal expanders in children and adolescents.
In contrast, an adult’s upper jaw bones are fused, and when a fixed palatal expansion device applies force, the palate is resistant to expansion. If forces are applied incorrectly to the teeth, serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss. These complications typically require intervention by a health care professional."
In case you you would like to view their full statement:
As of April 12, 2023, per CBS, the Feds have launched a criminal investigation into the AGGA device as well as its founder, who is also in court for civil litigation.
Unfortunately the official AGGA and Facial Beauty Institute website has been taken down (likely because of the ongoing lawsuits).
CBS reported that many patients have undergone this treatment or similar appliances and presented with extensive bone loss. Teeth were essentially pushed out of their bony housing and no longer have periodontal support. Many teeth were likely to be lost and/or have questionable long-term prognoses. Per patient anecdotes, CBS was told that these devices will grow jaws and that patients won’t need jaw surgery that surgeons and/or orthodontists might suggest is necessary.
Although the AGGA website is not available, I tried to ascertain more information through other websites that market the appliance. AGGA and similar devices are fixed “biomimetic” functional appliances that aim to apply pressure to expand the upper jaw in the A-P dimension. What I mean by "A-P dimension": that would be looking at your face from a profile view and expanding forwards/outwards. The AGGA is designed with piece of plastic on the palate to apply pressure. Those who market the AGGA hypothesize that this pressure causes bone to grow throughout the jaws and face.
Proponents claim that the AGGA unlocks one’s innate genetics and allow for biological growth that was inhibited previously. I found on one site that these appliances are “capable of restarting craniofacial development in adult patients as well as in children.” Therefore, they claim it will improve a patient’s airway and prevent snoring or sleep-disordered breathing through non-surgical airway remodeling. The FDA similarly note that these appliances from the Facial Beauty Institute and others seem to be marketed to cure sleep apnea, TMD/TMJ, and help one look more beautiful. There are no literature or clinical trials to prove this theory, to my knowledge, and as noted in the AGGA's founder's court deposition (shared via CBS).
The CBS investigation sheds light on a dilemma in healthcare: trusting practitioners and/or appliances that ultimately lack sound research or FDA approval. I don’t think that any healthcare provider knowingly wants to do harm to their patients. They seem to promote these appliances because they truly think they work and that they are helping people.
I did find ONE study that broadly compared many of these newer appliances that treat obstructive sleep apnea to more traditional orthopedic expansion protocols. Li and Guilleminault in 2022 compared the following surgical and non-surgical maxillary expansion techniques: DOME, MARPE, AGGA, DNA and ALF treatments. I plan to describe the rest of these appliances and treatments in the following sections of this article as well as in Part Two.
Here is the reference:
Li, Kasey & Guilleminault, Christian (2022). Maxillomandibular Advancement for OSA: A 25-year perspective. L' Orthodontie francaise. 93. 79-92.
Although the sample size was low in this study, all sixteen non-surgically treated patients (i.e., those who used the MARPE, AGGA, DNA and ALF) did not illustrate any separation of the midpalatal suture. All expansion movements seemed to result from dental tipping with no skeletal changes. Of these, ten patients noted thinning of the facial/buccal bone with gingival recession. All five patients that underwent AGGA treatment exhibited significant mobility of the maxillary anterior teeth due to vertical and horizontal bone loss.
Here are a few pictures showing the AGGA in action, which are derived from the study performed by Li and Guilleminault (2022). This picture illustrates the anterior displacement of the front six teeth and a notable gap between the canines and premolars that developed as a consequence.
The following images depict the radiographic changes of the bone, wherein the maxillary anterior teeth are displaced out of the bone:
Lets talk about a few other popularized appliances:
ALF stands for Alternative Lightwire Functionals. Supporters suggest that the ALF design, like the AGGA, is based on replicating the forces to the jaws and head that “nature intended”. ALF's makers additionally suggest that it helps improve the tongue’s position. The ALF is represented in image "a" in the photo from Li and Guilleminault (2022).
The ALF uses a removable wire that flexes into place and moves like a spring when the tongue pushes on it. I can draw some parallels of this device to myofunctional therapy (something we will review more in Part Three); however, I presume that there are biological limitations and it may take significant time before observable progress. Until there is evidence-based literature, I will struggle to support these appliances.
What about Vivos’ DNA appliance? It was just FDA-approved!
I attended a course in 2015 about the DNA device, which recently I understood was taught by an AGGA provider, coincidentally. I was fresh out of residency, and I remember thinking to myself, this looks like a removable palatal expander.
The Vivos DNA (Daytime-Nighttime Appliance) is a little different from the other appliances mentioned in terms of its design (photo credit: Li and Guilleminault, 2022). The DNA is sometimes combined with the Mandibular Repositioning Nighttime Appliance (mRNA), as seen in this photograph. It is essentially a removable three-piece palatal expander with finger springs that push on the front six teeth to advance them forward. While they do have literature published, I recommend that one might look a little deeper. These few studies seem to be performed in-house, and the main or primary author (Dr. Singh) is a primary developer of the appliance itself. Furthermore, the studies have a sample size of one patient or a very low sample size otherwise.
I perused several websites that promote the DNA and many show the same airway before and after photos. That seems to be a misrepresentation; these marketers are not illustrating cases that they have treated themselves. In regards to the FDA approval of the DNA for mild to moderate OSA treatment, data submitted for the FDA’s clinical review indicated that 86% of patients had their airway size improved, and 97% saw increased width of their palate. I already mentioned my opinion on their publications, so I will leave it at that.
This paragraph is a bit technical; feel free to skip it. Since the DNA is removable and designed to be worn only at night, it provides intermittent forces. Ideally, orthodontic forces to best support bone remodeling are meant to be light and continuous pressures. Intermittent forces from a bone biology perspective take longer before seeing observable change. Most articles mention that the DNA is to be worn and adjusted for as long as 12-18 months.
I think that patient selection, constant monitoring and patience will be critical to those who select this treatment. It is possible that it might help some people, and I’m not saying it doesn’t. However, I believe that due to the absence of sound data there is a risk that one is taking. There are ultimately physiological limits to how much expansion one may achieve, especially in the adult population. I also think one of the biggest trade offs with this and similar appliances will be time. The activations will be extremely slow and I am thinking it could take even years before one sees results.
On top of this, if a patient wants to also work on dental alignment, braces or aligners will need to follow this expansion phase. Many of these patients will have crooked teeth, tongue ties, poor posture, and/or mouth breathing. I still do not think these other contributors to OSA/TMJ concerns are being addressed with these appliances alone. Needless to say, one might say that the DNA appliance or one of the others is more palatable since it is not as invasive as a MARPE/MSE or SARPE procedure (we will go over these treatments in Part Two). However, these procedures show substantial data and notable outcomes in a shorter amount of time.
Lastly, I wanted to mention as an aside that I will almost always recommend an ENT, oral surgeon, TMJ specialist, and/or myofunctional evaluation when I see airway and/or TMJ concerns. In children and adults, alike. Both the etiologies and treatments for sleep disordered breathing and temporomandibular joint dysfunction are complex and multifactorial. I think it takes a team approach to comprehensively address these health conditions.
Up next: In Part Two we will discuss traditional rapid palatal expansion (RPE) and newer RPE advancements. Stay tuned!