David B. Rosen, D.M.D.- Practice Limited to Periodontics & Dental Implants

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FAQs:

1.
What is an oral appliance?
2.
Is there only one available?
3.
Will an oral appliance help me?
4.
Do they all work the same?
5.
How do I choose the correct appliance for me?
6.
How long do they last?
7.
How do I know it's working?
8.
Will my insurance pay?
9.
How do I take care of my appliance?
10.
Are there any bad side effects that oral appliance can cause?
11.
Which Oral Appliances are acceptanced by the FDA ?

1. What is an oral appliance

Answer: It is a piece of plastic or silicone that fits completely or partially within the mouth and holds oral structures in a position that allows easier breathing when you sleep.

2. Is there only one available?

Answer: There are many appliances commercially available. Only 16 of them are accepted by the Food and Drug Administration for the treatment of obstructive sleep apnea. Many dentists make their own appliances, few of which have been tested for efficacy.

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3. Will an oral appliance help me?

Answer: This is very difficult to answer easily. Research shows that certain patients respond better to oral appliances. Characteristics, I like to see are:

  • Normal weight or moderately overweight.
  • Older than 18 and younger than 65.
  • Healthy teeth.
  • Being "Buck toothed" with a small chin.
  • A jaw line parallel with the floor.
  • A patient who has failed throat surgery.
  • Patients who have mild or moderate obstructive sleep apnea.

 

Even though there are many successful oral appliance users who do not fall within these guidelines, the fewer positive characteristics a patient has, the less successful he or she is expected to be.

4. Do they all work the same?

Answer: To this point there has never been research, which compares one FDA accepted oral appliance to another. They have compared appliances, which are FDA accepted for the treatment of sleep apnea to those that are accepted for treatment of snoring only, and found that those which were accepted for the treatment of sleep apnea were more effective treating sleep apnea than appliances accepted only for the treatment of snoring. Rather make sense doesn't.

Keep in mind, that the appliances are designed differently and have hardware in different positions. While the underlying effect of one appliance may be the same as the other, you may not be able to use a certain appliance because of the anatomy of your mouth or an allergic reaction. You want to work with a dentist who has knowledge of many different appliances.

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5. How do I choose the correct appliance for me?

Answer: My job to help guide the patient to selecting an appliance that fits their lifestyle and their anatomy. Some appliances allow you to speak easily, others make it impossible. All of them allow you to breathe through your mouth if your nose is stuffy. They are like houses; one style is not right for everyone.

6. How long do they last?

Answer: The lifespan of an oral appliance varies depending on its design. They will last anywhere from six months to six years. Some require more repairs than others. Some must be sent back to the laboratory to be repaired, others can be repaired in the office. If you grind your teeth, you will shorten the lifespan of your appliance dramatically. Very severe grinders may find an appliance impossible to wear.

7. How do I know it's working?

Answer: The real answer would be to have another sleep study, which would prove how effective the oral appliance is. Most patients will wait to be retested until their snoring stops and their symptoms go away.

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8. Will my insurance pay?

Answer: That depends.

Oral appliance therapy is considered medical treatment, and only medical insurance will pay for this. Many employers have insurance contracts with specific clauses denying coverage for oral appliance therapy. Some of these are the “Big Three” automakers and the Teamsters Union. Even some insurance companies, such as Blue Cross Blue Shield of Alabama have declared oral appliance therapy "experimental" and will not cover this treatment in any of its policies, even though oral appliance therapy has existed since 1982. If you belong to a PPO, EPO or HMO plan, it is possible there will not be an in-network provider and you will be held liable for your annual deductible and co-payment.

9. How do I take care of my appliance?

Answer: Very much like you do your teeth. You need to brush the appliance thoroughly, both inside and out each morning when you take it out of your mouth. You need to pay attention to all of the hardware and small nooks and crannies. The best cleaning agent I have ever found, to assist you in keeping your appliance clean, is Oral Safe. It is available from Great Leaks Orthodontics, Limited at:info@greatlakesortho.com.

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10. Are there any bad side effects that oral appliance can cause?

Answer: Of course!

Short-term side effects include excess salivation, dry mouth, tooth pain, and joint pain. All of these are easily corrected with time or adjustment of the appliance by your dentist.

Long-term side effects are much more of a problem. The literature reports, as many as half the patients wearing an oral appliance long-term will have changes in a position of their teeth and, sometimes, their jaws. If you stop wearing the appliance in the first six months of use, most of these changes are easily correctable. After that it may require orthodontic therapy, to put things back where they started. You need to let your dentist know immediately if you think there are any changes.

You must balance the positive effect of the appliance against the negative side effects experience.

 

 

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Which Oral Appliances are acceptanced by the FDA ? [Table]

The job of the FDA is to protect consumers and make sure that the benefits of a product outweigh the risks. Their committee on medical devices determined that for the purposes of treatment, snoring and sleep apnea are considered medical diseases and that all oral appliances designed to treat these diseases fall under the umbrella FDA control. In order to receive FDA acceptance, the developers of an appliance must submit data which prove its usefulness and relative safety. All appliances that are accepted by the FDA for treatment of obstructive sleep apnea are custom made. This means that the patient must have impressions of his mouth made and the appliance is made in a laboratory directly on the resulting plaster models. Many dentists, and some physicians, use pre-fabricated appliances that are heated in boiling water and the patient is requested to bite down into the softened material until it cools. Be aware, as of this time, no pre-fabricated appliances are accepted by the FDA for treatment of sleep apnea. Each patient should make sure that the appliance being made for him/her is FDA accepted.

 

Taking Impression

Impression being taken for fabrication

Bite Registration
Bite registration being recorded for fabrication on an appliance of an appliance

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All oral appliances are mandated to be available by prescription only, not OTC (over the counter).

The FDA assures:

1.
Safety
2.
Performance - does it do what it is supposed to do?
3.
Effectiveness - is a significant target portion clinically successful?
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Appliance
Accepted for Tx Snoring
Accepted for Tx OSA

Snore Guard™

•

Tongue Retaining Device™

•
•

Klearway*™

•
•

PM Positioner

•
•

Equalizer ™

•

Nocturnal Airway Patency Appliance (NAPA)™

•
•

Sleep and Nocturnal Obstruction Patency Appliance (SNOAR)™

•
•

TAP* ™

•
•

Tongue Locking Device™

•

Herbst Appliance*™

•
Adjustable Soft Palate Lifter ™
•
•
•
Silent Night™
•

EMA*™

•
•
* adjustable appliance
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[not a complete list]

N.B.
Since bruxers and clenchers exhibit a higher frequency of sleep apnea than patients without parafunctional habits, AND clenching and bruxing may contribute to the morning headaches reported by OSA patients, then it is possible that some type of nightguard or splint would be beneficial
 

 

 

 

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Copyright © 2003 David B. Rosen, D.M.D.
Last modified: March 07, 2005