SleepDent

It is true that all mandibular advancement devices ultimately work by advancing the mandible, but in terms of efficacy, the devil is in the details, for instance, some devices have very coarse strap adjustments and a relatively limited range of adjustability and these tend to be less effective than devices with fine adjustment mechanisms and a much wider range of protrusive movement. Many appliances are designed to allow free opening and closing of the mouth in the name of comfort, but it is widely recognized by experienced sleep dentists and some manufacturers that appliances that keep the mouth from falling open have better rates of efficacy than the ones that allow the mouth to fall open even though they both can produce the same amount of mandibular protrusion(I have a good study to support this and will submit it when I locate it in my records). These things matter and patients have the right to know about the differences and that all appliances are not "essentially" the same. Again, more research needs to be done on these things. Arthur B. Luisi, Jr.,D.M.D.

Absolutely, Each efficacy study must be carefully evaluated as to the selection criteria for the patients, what is defined as success, the amount and time of follow-up, and many other things. It is a very complicated process. The efficacy rates WILL vary depending on how these factors line up. One of the big problems is that the different studies use so many different assumptions that the results can not be compared. Comparing Apples to Oranges. Never-the-less, it is clear that some appliances are more effective in real life than others. One study is not conclusive, but there are trends. Any experienced sleep dentist who sleep tests their appliances gets a feel for which appliances are doing better and there are differences. I am not going to name names, but I have had repeated instances in my practice where patients came in with certain appliances that have not tested well in their sleep studies with oral appliance in place and then I have substituted another design and the new sleep study with oral appliance in place shows good results. My real point is that we can do better than this. Efficacy testing needs to be standardized with the same assumptions for each test so that the results can be compared. Probably, the tests need to be administered by one agency for uniformity, possibly the F.D.A.. More research needs to be done into the effects of different designs with respect to efficacy. My sense of it is, with more research, we can offer oral appliances that are uniformly more effective for the patients and break the "50%" barrier. At least that is my hope. Arthur B. Luisi, Jr.,D.M.D.

I respectfully disagree that strong evidence, comparing one oral appliance design to another, has shown no difference between how well they work. It is clear that, all other things being equal, oral appliances that hold the mouth closed(do not allow the mouth to fall open at night) will have significantly better efficacy than designs that do allow the mouth to fall open in the name of "comfort". Please see the study that I have posted from the J Oral Rehabil. under the topic "Patients deserve oral sleep apnea appliances that work". It is fairly common knowledge among sleep dentists and OA manufacturers the oral appliances that hold the mouth closed work better. Arthur B. Luisi, Jr., D.M.D.

Very interesting point. I have been answering questions on these forums for many years and do try to only make assertions that are scientifically supportable. In this case, I thought that the efficacy was self-evident, but apparently not. I would say that common sense tells you that if you have an aligner with holes in the matrix for each tooth and the teeth continue to fit into the same holes, the teeth couldn't have moved very far. At least I would think so, but maybe not? I definitely agree that compliance is a problem with the aligners. This would be anecdotal from my practice, but the patients that are very compliant with the aligners don't seem to get into much trouble and some of the non-compliant people in my practice are the ones have gotten the tooth movement and bite change. But over-all, bite change and tooth movement haven't been a big problem. Ultimately, it gets down to the patients' priorities. If a patient is CPAP intolerant and gets good results with an oral appliance, is the risk of some tooth movement and some bite change a fair trade off for a good night's sleep, waking up refreshed in the morning, having good daytime energy, and taking heart attack, stroke, AFIB, etc. off the table a worthy trade-off. I think that many patients have and would say yes, providing that it is an informed choice. Arthur B. Luisi, Jr., D.M.D.

Obstructive sleep apnea is a really, really big deal. It has destroyed people's careers. It has ruined their marriages. It has caused car accidents. It has ended peoples lives. Oral sleep apnea appliances are a critical piece of durable medical equipment that should be treated with the utmost seriousness. In my opinion, sleep dentists have been far too polite for far to long in not calling out the oral appliances that work very poorly. The present oral appliance landscape is like the Wild West. Minimally regulated "snoring appliances" crowd the internet and are on T.V.. It is a poorly kept secret that these appliances are being used by a significant number of suspected and diagnosed patients with OSA due to their extremely low prices. This should simply not be allowed to happen. There are over 100 different oral appliances currently on the market. Some of these are very poorly designed and have very low efficacy rates. Naive patients and some uninformed dentists are victimized by these appliances. The current F.D.A. "clearance" procedure for oral appliances is so weak that it is basically a farce. Patients have a right to know if the efficacy rate for an appliance is 24% or 84% and both could be true. I firmly believe that for any manufacturer who wants to market an oral appliance, they should be required to submit independent, third party, peer-reviewed efficacy data to the F.D.A.. There should be stringent minimal standards for efficacy that must be met by the appliance or it can't be sold. Period. Manufacturers will claim that it is too expensive to test their appliances for efficacy. NOT OUR PROBLEM. If they don't have the resources to back their products adequately, just go away. Patient's lives depend on it. Arthur B. Luisi, Jr.,D.M.D.

You are welcome. The few patients with dry mouth problems that I have been able to get prototype mouth shields for have definitely been helped. Just make sure that you work on getting your nasal patency in the best possible shape prior to starting the mouth shield so that the air can go easily through the nose. Arthur B. Luisi, Jr., D.M.D.

Sorry, I took so long to get back to you, but there was no information. According to the General Manager of Airway Management, the intra-oral mouth shields for the Tap3/DreamTap should be commercially available by the end of the second quarter, 2018. The final production-ready prototypes have been approved and signed off. I have been given a very few pre-production prototypes to test and I can say that the final design does work well. They are currently working on the tooling for production, so things are looking up. Arthur B. Luisi, Jr., D.M.D.

Since this post is about OTC appliances, I want to talk about a very important aspect of it. Obstructive sleep apnea is a VERY big deal. It has ended people's jobs, it has ended people's marriages, it has ended people's lives. I think that sleep dentists have been too polite about the issue of which appliances really work for far too long. If a patient is offered an appliance with a success rate of 25% vs. one with a success rate of 84%, the repercussions could be devastating for him. This has to stop. The current oral sleep apnea appliance landscape is like the Wild West. You have minimally regulated OTC "anti-snoring" appliances of all kinds on the internet. It is a poorly kept secret that significant numbers of people with suspected or diagnosed OSA are self-treating with these appliances because of the low cost, "Wink. Wink". This simply should not be allowed to happen in my opinion. The F.D.A. "clearance" procedure for actual OSA appliances is so weak that it is basically a farce. In my view, EVERY manufacturer of oral sleep apnea appliances should be required by law to submit independent, third party, peer-reviewed efficacy data to the F.D.A. as a pre-conditon to entering the market. There should be stringent minimal standards for appliance efficacy. If you can't meet them, you can't sell the appliance. Period. Now, the manufacturers will say that the testing is too expensive. NOT OUR PROBLEM. Patients would be better served by having a more limited selection of safe, high quality, effective appliances to choose from anyway. Arthur B. Luisi, Jr., D.M.D.

While it is true that the success rate of oral appliances consistently sits at about 50%, I feel that this is somewhat misleading in that this would be an over-all average for a wide range of appliances. There are definitely oral appliances capable of much better efficacy rates than that. Most notably, the TAP line of appliances. A very well regarded study by Dr. Arnaud Hoekema showed an efficacy rate for the Tap at about 84% for mild to moderate cases of OSA. So it behooves sleep dentists to know the efficacy rates for the various appliances and to select the best. You can certainly do better than 50% for mild to moderate OSA. I know that I do. Arthur B. Luisi, Jr. D.M.D.

To mitigate the tooth movement effects of oral appliances, I feel that it is very important to use a resetting appliance in the morning after using an oral appliance all night. My resetting appliance of choice happens to be the A.M. Aligner supplied by Airway Management. Basically, it is a pink wafer that is heated and used to record what your bite and tooth alignment is pre-appliance. It is inserted about 30 minutes after the OA is removed and used for 5 to 10 minutes. The A.M. Aligner returns your bite and your tooth positions back to where it was the night before. It has been my experience that, if patients use it every day properly, they seldom have significant tooth movement or bite change, assuming that their bone support of the teeth and their periodontal condition was acceptable to start with. Of course there are no 100% guarantees about it though. Arthur B. Luisi, Jr., D.M.D.