PROBLEMS WITH PURE SLEEP appliance

I received a phone call from Scott about problems from his Pure Sleep Appliance. I would like to thank him for voluntaring this info for my blog. See below and them my commentary.

My name is Scott Kizzia. I bought a Puresleep device about a year ago to alleviate a snoring problem. After approximately nine or ten months I started having some pain in my jaw and a little difficulty opening my mouth fully, especially early in the morning. As time progressed, it continued to get worse to the point that it was painful to put the devise in my mouth. Additionally, the pain opening my mouth fully was such that I could no longer eat items that required a fully open mouth such as a sandwich. I have recently reset my Puresleep devise where the forward movement of my jaw has been decreased and my jaw problem has gotten somewhat better. I still can not open my mouth wide enough to eat many larger items, but the pain has subsided noticeably.

Scott Kizzia
Centerville, TX

Scott has graciously sent me this e-mail for publicatin on my sleep blogs. The principle behind pure sleep is sound but not necessarily safe for an over the counter appliance. The FDA in the past would have prevented sales of such a device but has suspened any and all regulation that I know of.

Oral appliances can cause tooth movement and bite changes. The American Academy of Sleep Medicine Reccomended that dentists experience in treating TMJ disorders utilize oral appliances to treat sleep apnea.

The real danger is that sleep apnea diagnosis is not made leaving patienbts at greatly increase risk or heart attack , stroke and motor vehicle accidents. I fear it is only a matter of time until we see late night ads from attorneys looking for accident victims when the driver used pure sleep appliances.

In addition patients like Scott can suffer irreparable damage from unsupervised use of orthopeic appliances. The FDA has abdicated it's role in protecting the public.
dentists are often guilty of abicating their legal responsibilities by fitting patients with oral appliances for treating snoring and sleep apnea without adequate follow-up.

The symptoms Scott describes may be a Close-Lock of the TM Joint disc. Please, if you think you have sleep apnea see a qualified sleep physician and utilize CPAP. If you want a CPAP alternative find a dentist with training in Dental Sleep Meicine and always have a follow-up sleep test with the appliance. Additional information on TMJ disorders can be found at www.ihateheadaches.org

Dentists are not legally qualified to diagnose the presence or absence of sleep apnea. A few dentists may have the required medical expertise but diagnosis is still not within the scope of their dental licensce.