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BGailDemko140

BGailDemko140
Joined Nov 2015
Bio

Expert advisor to the FDA in oral appliance's (OA) for sleep apnea Associate Editor of the Journal of Dental Sleep Medicine

30 years of OA experience

US

BGailDemko140
Joined Nov 2015
Bio

Expert advisor to the FDA in oral appliance's (OA) for sleep apnea Associate Editor of the Journal of Dental Sleep Medicine

30 years of OA experience

US

Effectiveness of an oral appliance is normally based on the action of moving the bottom jaw forward; they all work the same. A patient continuing with treatment is based on many things. Comfort is # 1 and the fit of the appliance is #2. Studies published as recently as December of last year show that half of the people who get an oral appliance stop using it in the first year...and these appliances were custom fitted by a dentist. Oral appliance therapy is not for everyone!!!! It works half as well as CPAP (but more patients use it all night) and has side effects. As to F.D.A. clearance, the FDA's job is to protect the public from dangerous therapies. All devices cleared (this includes the custom fitted devices use by Dr. Luisi) must be made of materials safe to be used in the mouth (no cancer producing materials, etc.) and must prove they are essentially equivalent to a device previously found to be safe for use. Even the custom made devices used by dentists do not have to 'prove' they work, only that they are safe. All devices have side-effects and very few studies show that one appliance is safer or more effective than another. Efficacy rates only apply to scientific studies and cannot be generalized to a real life situation. In one study an appliance my be effective in treating sleep apnea in 25 % of the patients and in another study as effective as 50%. Thus data must be analyzed for the quality of the study, the people being studied (were they all young or old or overweight) and then compared to the quality of other studies. People who do not understand evidence based medicine often believe that numbers from a single study are to be taken as a fact, not as an indication of a certain outcome.

I must post a comment on side-effects with oral appliances (OAs). As Dr. Luisi stated, these devices put significant force on the teeth because they all began life as orthodontic appliances in the 1970’s (based on a device actually invented in 1909). That being said, all OAs, regardless of who makes them, have the possibility of moving teeth and actually moving the entire lower jaw. What we do know is that people with advanced gum disease and resulting bone loss will rapidly see tooth movement (and even lose teeth). Those who undergo orthodontic therapy after the age of 21 have a 99% change of developing tooth movement with the use of an OA. It occurs least in those with a healthy dentition and never had orthodontic therapy.

Long term studies, looking at patients who have used an OA for more than 10 years, find that the side-effects of OAs increase with the time used. Those using an OA for 10 years had much more tooth movement than those using it for 2 years. Patients who used the OA all night long had more tooth movement than those who used it for 4 hours/ night.

Dr. Luisi is correct that a qualified dentist (www.aadsm.org/dentistqualified.aspx) can help choose an OA that can limit forces on individually weakened teeth or spread the forces out over all the teeth. This should help limit tooth movement and unwanted side-effects. A qualified dentist can also monitor changes in your jaw alignment and warn you that there might be problems since the majority of people do not feel any problem until it is very advanced.

My favorite treatment regimen in those who use CPAP for 4 hours each night is for them to use CPAP for the time they can and then switch to their OA for the rest of the night. This get a patient treated all night long and limits the side-effects of either treatment.

Updated research on the effectiveness of mandibular advancement oral appliances (OAs) is always forthcoming and there is a journal that prints nothing but articles about this form of treatment. The success rate of oral appliances sits consistently at about 50%. That means that half the people who get an OA respond as well to the OA as others do to CPAP. Interestingly, 20% get better, but would not be considered to have controlled their sleep apnea by their sleep physician. A solid 25% do not improve and a few even get worse. After 20 years of research as to who will be effectively treated with an OA, we still cannot predict who that will be. Since we do not know who will respond to an OA and who will not, all people who get an oral appliance MUST return to see their sleep physician and most of these need to have actual sleep testing to make sure the OA is working.

On thing that does make physicians happy, and dentists too, is that the average nightly use of an OA is 6 hours/ night and the average use of CPAP closer to 4 hours / night. That means that people who are only partially treated with an OA, but use it all night may have the same medical improvement as someone who uses CPAP for 2-3 hours per night. All treatments used for the entire sleep time work better than a treatment used only part of the night.

All surgical approaches are less effective long term than CPAP and OAs. Even double jaw surgery (MMA advancement) will eventually fail. CPAP is the only treatment that does not fail with long term treatment.

Oral appliance therapy is best done with a dentist trained in the field. The American Board of Dental Sleep Medicine (www.ABDSM.org) oversees a rigorous examination and submission of completed cases (with sleep studies before and after) and has a list of qualified dentists in the US and Canada. While the list is quite limited at the moment, more than 100 dentist have already signed up to take the next exam.

Important data to know about oral appliance therapy is that they do not always work. Unlike CPAP which can open the entire collapsible airway (4" in women and 5" in men), oral appliance are site specific. Since your physician does not know where your blockage is, there is no way to predict if oral appliance therapy will be successful; this can be a very expensive trial and error adventure. Medical insurance will often cover the cost of an oral appliance if you have been diagnosed by a physician with sleep apnea. There are many rules that are unique to each insurance company. An example is that Medicare requires that you have a sleep study that is no more than 1 year old at the time of oral appliance therapy. Seems as if dentist have to follow the rules laid down for CPAP companies.

Oral appliances are more effective in patients with mild to moderate sleep apnea, who are of normal weight and who needed CPAP pressure lower than 13.

Side effects are related to the fact that the oral appliances in use belong to a class of orthodontic devices developed over 100 year ago to permanently move forward small lower jaws in children. Where the children had to wear the device 24 hours / day for 5 years, patients with sleep apnea only have to use the appliance during sleep. While some patients can have permanent jaw movement (I guess this is good if you have a small lower jaw), many dentist have developed various ways that can help you maintain normal jaw position. Switching between CPAP and oral appliance use could be one way of limiting side-effects.