Consensus on Sleep Apnea Oral Appliance Selection Protocols

(Mark Collins, Dennis Marangos, Gina Pepitone-Mattiello, John Viviano, Steve Lamberg, Kent Smith, Erin Elliott, Harry Ball, John Carollo, Ken Luco, Shouresh Charkhandeh, Tim Mickiewicz, Barry Glassman, Christopher Kelly, Keith Thornton, Bob Rogers)

 

The LinkedIn Discussion Group, “SleepDisordersDentistry” has just completed an open discussion on “Appliance Selection Protocols” Here is a consensus for all to ponder.

What was asked,

 “We all have favored appliances. But the reality is that no one appliance is suitable for every patient. Share your protocols regarding how and why you select a particular appliance. Tell us about your favorite and why it’s your favorite and tell us about appliances that work particularly well for certain patient phenotypes…”

 

What was said,

 There is universal agreement that all appliances have pluses and minuses. Some clinicians suggest that limiting the number of different appliances helps to reduce confusion in the office with follow-ups and complications. However, others speak of offering a variety of appliances so the appropriate appliance can be matched to the patient. Appliances that are available with a soft liner are preferred by some due to ease of fit and speed of delivery; they are gentler on the teeth, and particularly helpful when dealing with heavily restored teeth, veneers or crown and bridge. However, it was also pointed out that the soft lined appliances do not last as long as the full hard acrylic appliances. Most agree that it is prudent to become familiar with different device styles to best match the device to various patient presentations. Not one patient is the same and hardly predictable when it comes to how their condition or physiology will react to a device. Some of the considerations mentioned include severity, type of OSA, anatomy, Medicare guidelines and of course patient preference. ie: You cannot fabricate a Herbst device if a patient refuses to wear it.

However, clinicians are divided as to whether or not the patient should be part of the decision process; some make it part of their routine and others absolutely disagree with that notion. The “PRO CHOICE” clinicians typically select 2 or 3 appliances that are suitable for the patient and let the patient pick the appliance that most appeals to them. The rational being that if a patient selects the appliance, adherence may be higher (rather than forcing them towards our choice of appliance). In contrast, some clinicians feel very strongly that appliance choice is the dentist's decision, based on all the clinical findings for that case. It was pointed out that when an MD prescribes a medication, they do not ask which one we want, they tell us “we'll try this one and see what happens, and change it if necessary”.

All this being said, Steve Lamberg pointed out,  

“It’s not the arrow, it’s the Indian", suggestive that it is more about the clinician than the appliance.

However, Dennis Marangos followed with,

"If all you have is a hammer, everything becomes a nail. Those that only use one appliance make it fit however they can. If treatment fails, they "blame" the patient (for various reasons), the Lab but never themselves. Does one medication treat all hypertension? No, it has to be customized to the patient, as should appliance choice.“, suggestive that it is more about the appliance than the clinician.

Personally, I agree that it is not a good idea to be a "one trick" act. However, Wayne Halstrom, the developer of the first adjustable oral appliance (Silencer), once told me,

"John, a fish hook will work if it holds the jaw in the right position!"

So, although we have theorized all this criteria to consider (non of it evidenced based), it seems to me that an appliance that the patient can comfortably tolerate, that allows adjustment and that is durable qualifies for the “fish hook”, as long as it holds the jaw in the right position. No need to make it more complicated than that.

Having said all of this, if a patient comes in wanting an appliance they have previously worn successfully, its pretty well a “No Brainer” to stick with what is proven to be successful.

 The following is some of the rational clinicians cited for selecting a particular appliance…

Herbst:

Clinicians that see a lot of Medicare patients are somewhat limited to Medicare approved appliances such as the Herbst. It was also recommended for heavy bruxers, strong muscles or potential TMJ concerns.

Somnodent:

The Somnodent was recommended for edentulous or partially edentulous patients. It is particularly amiable to incorporating implants for those with little or not dentition. However, in a subset of patients the Somnodent seems to be prone to breakage of the dorsal fins and/or the screw mechanism. However, many feel that the Somnodent is well made, comfortable, smooth, durable and “quick and predictable” to deliver chair-side.

TAP:

The TAP III works well for those patients that do not have large tongues or narrow arches which crowd the tongue. These folks sometimes have a problem with the screw mechanism in the anterior. The TAP can be difficult to fit when the teeth are crowded but works well when there is extensive dental work planned in their near future.

Keith provided us with a Meta-analysis that he prepared using the studies used to establish the 2016 AADSM / AASM joint Guidelines. His findings are quite remarkable and are worth a read. I can’t comment as to the scientific validity of this comparison, but regardless, I find myself looking at the TAP with renewed interest. Check it out at the following Link:

https://www.sleepdisordersdentistry.com/resources/2015/11/1/meta-analysis-of-oral-appliance-effectiveness

Narval:

Positive comments about the Narval included, skirts the anterior teeth protecting them in cases of fragile dentistry, small size, strong material, easily replaced due to digital manufacture using stored files. However, special precautions have to be taken if completing major dentistry post appliance insertion. Although it is not necessary, some use the Narval only when dealing with virgin or close to virgin dentitions. The truth remains that the type 12 polyamide nylon used in the manufacture of the Narval is quite remarkable and unlike any other dental material we have used to date. The following eBook on the 3D printed appliances is very useful regarding getting to know the nuances of these devices, in particular, appliance design selection and adjustment of the nylon material. This eBook has information on both the Narval and D-SAD appliances.

https://www.sleepdisordersdentistry.com/morepracticalpearls/

D-SAD:

The D-SAD appliance has many occlusal options. It can have bilateral contact which would be in the premolars and 1st molar region, or, you can have an anterior discluding stop, which can be defined to be over the central incisors, the centrals and laterals, or from cuspid to cuspid. The D-SAD also provides various strength straps to deal with advancement strap fracture, which occurs in a subset of heavy bruxing patients. Of course, the 5-year warrantee provided by the manufacturer is also quite appealing. The "parallel propulsion force” approach of the D-SAD (also found in the Narval) was also discussed as a potential benefit.

 EMA:

The EMA is ideal for simple snoring and as a transitional appliance during other dental procedures (prostho, resto, etc). However, one clinician referred to it as “cheap feeling” in the mouth. Posterior Pads are available for the EMA for those that do want posterior contact.

Oasys:

It was discussed that the Oasys can be used in combination with Invisalign or for upper edentulous patients. Also, a recent enhancement to the Oasys includes a tongue-stabilizing feature. Oasys is also helpful for patients with nasal resistance and some patients state their tongue posture has changed (for the better) after using the Oasys. However, due to its size one has to ensure that it won’t interfere with lip seal (for those that believe that lip seal is important).

Full Breath:

“Difficulties with gaging” was the only commentary on the Full Breath appliance.

Moses:

One clinician reported that the Moses provides a good vertical result, but the vacuum formed upper has a cheap feel to it in contrast to the acrylic lower. However, he reports that the appliance both works and holds up well.

Lamberg SleepWell:

The LSW can be adapted to most situations and offers freedom of movement (both vertical and lateral) that is unusually accommodating to the patient. It is easily adjusted and easily cleaned and bruxers also do well with it. The "Minimum" vertical dimension is adjustable in 3mm increments and the protrusive in .5mm increments. Side sleepers do very well although the advancement mechanism in over the upper incisors and may compete with the tongue if it's huge. Overall it has a non-threatening appearance and can be easily altered in the case of new dental restorations. The price point is favorable as well. It is made by SML (space maintainers) so you will get consistent quality. It can be made with posterior support if chosen with a novel anterior jig to allow continuity of posterior support when protrusion is increased. The future holds a digital milled version (thinner, lighter, more durable) of this appliance that will allow milling to be done locally by the clinician making delivery time to the patient within 48 hours.

SUAD:

The SUAD was recommended by a number of clinicians for heavy bruxers or patients with strong muscles.

MicrO2:

The MicrO2 was recommended for Mild cases where there is a concern about bulk.

TMJ Health and Appliance Design:

As has been the case with all of our consensus articles, the importance of “condyle and disk health” remains a major point of contention. Steve Lamberg and Dennis Marangos referred to a Piper classification of a 3a disc displacement being stable enough to treat with a sleep apnea appliance. Steve also suggested that the ability to identify the "stability index" of the condyle disc assembly could be helpful in appliance design and or selection. For lack of a better methodology he suggested that a negative “Load Test” and a 3a Piper classification qualified the patient for therapy with an anterior point stop appliance, but if loading the TMJ tests positive, he suggests using an appliance with posterior support. Steve also suggested that an appliance that allows you to vary the support design, even midstream is helpful. He quoted John Kois, "risk management is the basis of your decisions for the rest of your life".

At this point, Barry Glassman joined the discussion with the following insights:

• Asymmetry is everywhere

• Mandibular advancement by itself does not "load joints."

• Posterior contact increases force vector magnitude during Para-functional events

Force vectors do not bring the condyle posteriorly as has been suggested, and thus most joint pain is not a result of "pinched" retro-discal tissue, and the physical loading of the joint by the dentist does not duplicate force vector direction or magnitude of the cranio-mandibular musculature

Barry goes on to ask,

“Is there disk pathology that prevents us from treating a patient with OSA with mandibular advancement appliances?”

“ How critical is it, therefore, to diagnose the health and position of the disk in advancement of therapy?”

Barry suggests that,

“much of this information is unnecessary and may create fear of failure and prevent the dentist from treating the patient who may need his or her help, creating unnecessary pretreatment requirements, that makes treatment more difficult for every patient to obtain.”

and,

“Piper’s Classification was created by Piper and has not been published or validated by anyone other than Piper … by using this Classification there is an assumption that it is speaking a common language, which it isn’t”

and,

“the good news is that the joint and joint function isn't as complicated as some tend to make it; and it certainly isn't mysterious. And much of the mythology is based on altered structure causing altered pathological physiology. The good news is that most of that mythology is... well.. mythology. So dentists are able to use oral appliances in MANY patients with adapted anatomy and physiology without ever diagnosing the joint; and if they did a more thorough evaluation, may not have proceeded because of the myths.”

Keith Thornton shared the following information which helps shed some more light on this issue. Keith initially designed the TAP with "anterior guidance and posterior disclusion" based on his restorative and TMD training. This design allowed for unlimited protrusion without having to modify posterior contacts due to the Christenson phenomenon. However, should TMD symptoms arise (which he rarely sees), one can add posterior stops, essentially tripoding the occlusion of the appliance in protrusive. He cautions that stops must be built up and equilibrated every time the appliance is adjusted forward.

To keep the information arms length, Keith shared a list of questions that he wrote and the responses provided by Bob Rogers (no introduction needed). Here they are…

Q: Approx. how many patients have you treated, how many years, how many years in practice, credentials?

A: I suspect I've treated over 7000 patients over the last 25 years. Credentials: DMD, DABDSM.

Q: Type of practice (TMD, Sleep only, General, Prosthetic, % Sleep)?

A: 100% sleep.

Q: Do you always image and what kind?

A: The only imaging I do is a Panorex.

Q: Do you change or do anything clinically based on the imaging?

A: Based on the Panorex, my management strategy may change if the teeth are inadequate in which case I may not treat them at all. Same if the condyles are badly degenerated.

Q: Where do you get most of your patients (ie. sleep labs, patient referrals, others)?

A: Most of my patients come from physicians. Many from sleep labs. Many from PCP’s and other medical specialists. Occasionally from dentists. An occasional walk in.

Q: What percent have TMD issues on presentation : crepitus, pain, limitation of ROM?

A: Upon presentation about 50% of my patients have clicking or crepitus (non-painful, not dysfunctional) - no real problem, okay to treat. About 5% may have dysfunctional, painful clicks which need to be treated prior to OAT. (I'm really guessing at the numbers now)

Q: Do you pre treat the TMD before MAD therapy?

A: I do not personally treat TMD prior to therapy. Refer out as needed.

Q: Do you treat TMD patients that are referred for TMD and what is your usual appliance?

A: I do not treat TMD referrals.

Q: Do you add posterior stops routinely?

A: For my tap appliances, I do not add posterior stops routinely. This seems to work extremely well for me. I will add them if I have joint problems that will not resolve easily. Sometimes that works, sometimes not. I do use posterior stops routinely on the Medley Gold appliance (a variation of the EMA appliance). Seems to work well, too. I'm not convinced posterior stops are a big issue either way on a routine basis. I think most people do fine with or without them, actually. In my experience, a small minority either specifically need them or specifically don't.

Q: What do you do if patient develops pain (stop therapy, medications, protrude further?

A: If patients develop some jaw pain I typically start with discontinuing use of the appliance for a day or 2 and then resuming at a lesser protrusion. Then advancing slowly. This seems to work wonderfully well for the vast majority of people I've seen.

Q: How fast do you titrate?

A: I typically begin treatment at 50% of ROM or less. I want to make sure they're comfortable at first. After about 4 or 5 days, I have them advance somewhere between 0.5 and 1.0 mm every other day as comfort allows until subjective symptoms seem to be positively affected. I see them in the office every 3 to 4 weeks to touch base during this time.

Q: What appliances do you use and percentage?

A: I use about 40% TAP3TL. About 50% Medley Gold (variation of EMA appliance). About 5% SUAD. About 2% Herbst. About 2% Narval (for allergy patients). About 1% other (?).

Q: Do you use a specific appliance for TMD or Bruxism patients?

A: For heavy bruxers I use the SUAD. For hot or tender TM joints I will use the Medley Gold with an elastomeric strap rather than a rigid nylon link.

Q: How many develop TMD issues?

A: A fair amount of people will develop a minor, short-lived joint tenderness that is basically inconsequential. Maybe 5% develop TMJ issue that requires ceasing appliance use for a few days and then resuming at a lesser protrusion.

Q: How many of these stop therapy?

A: Maybe 2% develop a joint issue that requires discontinuing appliance use and perhaps referral to TMJ specialist.

Q: Do TMD issues usually improve, are exacerbated?

A: The vast majority of TMD issues improve. Every once in a while issues are exacerbated.

Q: Do you ever go to Tap-Pap for patients who can’t wear an appliance for TMD? 

A: I have a few patients on Tap-Pap for simple mandibular stabilization who can't tolerate much advancement due to joint issues.

Q: When do you do Tap-Pap and how often? 

A: I do very few Tap-Pap these days because I have the good fortune of being close to an incredible ENT who performs drug-induced sleep endoscopies (DISE) and then pharyngeal "nip and tuck" to augment efficacy of the appliance. In addition, the hypo-glossal nerve stimulation is very gratifying for a certain subset of people.

Keith shared that his background includes teaching TMD at the Pankey Institute for years. Although he did not state a number, I doubt there is anyone that has delivered more appliances than Keith. His personal experience is that TMD is less a concern than any SDB problem and that much of TMD and other symptoms are actually caused by SDB. On all TMD patients he will try a sleep appliance first, particularly the myTAP since it has even bilateral support and bio-mechanically can take load off the joint.

In Keith’s words,

“Bottom line, TMD is of little concern, I haven't seen permanent dysfunction of any joint, very few OSA patients present with TMD, routinely the patient has a greater range of motion, the literature on most appliances agree, sleep physicians use the TMD issues as a negative in the discussion of OA's, sleep appliances are in many cases the best treatment appliances for TMD and finally virtually all dentists can treat uncomplicated patients with high pretest probability of OSA.”

Although this may have deviated a bit from our discussion, the information from two clinician’s that have been in this game from the beginning needed to be included and provides insights on the TMJ evaluation debate, anterior point stop debate and also appliance selection. Thanks Keith and Bob.

Summary:

I would like to close with some great appliance selection insights provided to us by Shouresh Charkhandeh. Once again, Shouresh worded this so well, here it is pretty well as he wrote it.

The three major factors that influence his decision are,

1. Clinical relevance / applications ( e.g. patient's anatomy, occlusal scheme, dental health, ease and importance of adjustability, ease and importance of reline, vertical/clearance / lip competency, ...)

1. Patient's choice

1. Quality of fabrication / relationship with the lab / customer service.

He believes each one of these three factors to be equally important.

Shouresh prefers to present 2 or 3 qualifying appliances to the patient (keeping all the clinical and anatomical characteristics in mind) and lets them choose based on their preference / habits / Life-style. He offers appliances that are made by the labs that he has confidence in and personal experience with, and that provide quality work and customer service. 

If the patient has a lot of restorations, high risk of decay, a difficult path of insertion, he prefers appliances that are easier to adjust chair-side and also easier to reline. Something that is not made out of hard acrylic or similar material (e.g. Somnomed Flex or Tap). 

If the patient has very few restorations and healthier teeth, he prefers material used in the Narval, Panthera, MicrO2 and SomnoDent Classic.

Nocturnal mouth opening is also considered. Shouresh prefers appliances that allow mouth opening for patient comfort but uses mouth closing mechanisms such as elastic retention or engagement mechanisms that ensure the mouth does not open during sleep. (eg. MicrO2, SomnoDent, Narval, Panthera)

Material thickness requirement is another very important factor. If the patient has difficulty maintaining lip seal at 4-7 mm inter-incisal opening he uses appliances that require less opening. (Narval, Panthera)

Material strength is important with certain patients. He prefers a stronger material for heavy bruxism, patients with habits or those that exhibit the possibility of being neglectful. (Narval, Panthera)

If appliance lingual volume is a concern (therapeutic effectiveness or comfort) he prefers an appliance like the MicrO2 that has minimal tongue encroachment and a good mechanism to prevent mouth opening.

Shouresh points out that these are examples of considerations and are not an exhaustive list. To summarize, Shouresh looks at,

• What are the factors that should be considered and are important in a specific patient (the list of general factors are very long, but in each specific patient it usually is not that long) 
• Which appliance/appliances addresses most of these factors
• If more than one appliance qualifies, he let’s the patient pick
• If patient doesn't have a preference, he picks the lab that he has the best experiences with

So, in closing, there has been much discussion about the various design features that would make one appliance more desirable than another for a particular patient, and this is all good. However, much of this is based on our theories. For instance, in recent years, I have stayed away from appliances that have their attachment mechanism occupying tongue space, I have done this in spite of the fact that there is no evidence in the literature that one appliance design is more effective than another. So, I did this based on the theory that one is going to be more effective than another. In the very early years, I placed hundreds of Silencer appliances and guess what, some patients complained about the attachment mechanism, and some did not, but they all got over it. Never, did a patient tell me they couldn’t tolerate wearing it because of the attachment mechanism being a problem. So, is it really a concern when I steer away from an appliance that has an attachment mechanism in the oral cavity, or is it in my head? Some of the best oral appliance outcome studies have occurred using a TAP appliance; food for thought! Keith’s meta-analysis certainly has me looking at the TAP with fresh eyes. In the end, I think it is about getting to know the appliances you are using, and all of their nuances, so that you can best match them to your patients (based on theories we have devised but not proven), and best deal with issues that are bound to come up in various patients.

Once again, I would like to express a heartfelt thanks to all that participated in this discussion. As always, these consensus articles should be considered working documents, meant to guide those clinicians beginning in this field and also present some valuable insights to those of us that have been at it a while. I look forward to future discussions on our SleepDisordersDentistry LinkedIn group! 

John Viviano DDS D ABDSM

SleepDisordersDentistry.com

SleepDisordersDentistry LinkedIn Group