“Sleeping in Complete Comfort”
INDICATIONS FOR USE:
Medical: (FDA Clearance K130797)
- For the treatment of mild to moderate obstructive sleep apnea
- For the treatment of primary snoring
Dental: (FDA Clearance K160477)
- For the treatment of sleep bruxism
- To aid in the treatment of associated tension/migraine type headaches
This device is the first treatment the FDA has cleared for the treatment of sleep bruxism of any kind. Various medications have been studied, but to date, all have failed in treating sleep bruxism or the side effects were very severe. Similarly, because sleep bruxism does not have a psychological component, psychotherapies are ineffective at treating it.
This is the only dental device with both medical and dental uses and the only device FDA recognized for the treatment of patients who suffer from one or more of these diseases.
Also of note, the FDA has also cleared this device to aid in the treatment of the tension / migraine type headaches that often accompany sleep bruxism. No other OSA appliance can make that claim. Standard single arch (upper and lower) night guards only protect the teeth. They do nothing to treat the underlying sleep bruxism (and associated problems such as increased heart rate and blood pressure).
The Luco Hybrid OSA Appliance is unique in that it actually significantly reduces the number and the duration of sleep bruxism events that occur. It also significantly reduces the heart rate associated with each event, reducing the strain on the heart.
It has cast metal framework made from the same material as a cast partial denture and hip replacement. The acrylic allows for simple adjustments chairside for dental work that may be needed at a later date, should dental work be required. Figures 1 and 2 show the framework. Due to the strength of the cast framework, the appliance size is quite small and very comfortable to wear.
There is no material in the front to allow mouth breathing as needed. Many people suffer from allergies or have chronic stuffy noses. By eliminating all the material in the front, there is no restriction of mouth breathing. If you are claustrophobic, you will certainly appreciate this design!
Sleep bruxism occurs is known to occur in approximately 8-10% of the population. Over 80% of sleep bruxism events are associated with sleep arousals or disturbed sleep.
The FDA lists the development of TMJ Dysfunction as one of the four known risks of mandibular advancement appliances. Sleep bruxism is quite likely the reason why. Sleep bruxism places forces on the teeth, jaws, and TMJ at much greater levels than when chewing food. Inhibitory reflexes that are present when awake (and prevent us biting harder than needed to chew food) are inactive when sleeping. This overloads these structures leading to the damage seen from sleep bruxism. There are studies directly linking sleep apnea to TMD.
The Luco Hybrid OSA Appliance has a patented forward bite that directs the bite forces much differently than other OSA appliances. The drawing below demonstrates this design:
The animated below demonstrates the way this patented bite directs the bite force evenly up through the face and frontal bone with no high pressure (red) areas seen:
All other devices place the bite evenly across the device (including the molar regions. This results in a concentration of stress on the body of the mandible, the condyle, the TMJ and under and inside the eye region. This is demonstrated in the animation below. There are numerous high-stress areas depicted in red:
Because the Luco Hybrid OSA Appliance was carefully researched and developed with these principles in mind, it is the only OSA appliance that directs the bite forces in this way. This is also why this device is the only treatment of sleep bruxism (by reducing the number and duration of sleep bruxism events as well as reducing the associated increase in heart rate seen in sleep bruxism) to receive FDA clearance for this treatment to date.
If should be also noted that conventional bruxism appliances or night guards are ineffective in the treatment of sleep bruxism, they only provide protection from the bruxism events. This is evidenced by grooves worn into these devices in a short time or cracks developing during use.
The Luco Hybrid OSA Appliance is the only OSA appliance clinically proven to reduce the trigemino-cardiac reflex associated increase in heart rate associated with sleep bruxism.
Home sleep studies we have conducted have actually shown that single arch night guards actually increase the number of sleep bruxism events and increase in heart rate! The significance, of course, is that the associated increase in heart rate is unaffected or actually increased when these devices are worn in some. This demonstrates that single arch night guards continue to stimulate the trigemino-cardiac reflex.
The following image demonstrates the increase in heart rate caused by stimulation of the TCR reflex by sleep bruxism: (click to enlarge)
Of note, the heart rate increased from 75 to 100 beats per minute demonstrating an increase of 25%. This meets the criteria of stimulation of the TCR (>20%).
The Luco Hybrid OSA Appliance is clinically proven and FDA cleared as the only true treatment of sleep bruxism. If you suffer from OSA and sleep bruxism, this is the only device that can treat both conditions together. And, if you wear a CPAP and suffer from sleep bruxism, we have very successfully used this device with CPAP therapy (by simply having a mask fitted to the device jaw positioning).
And as sleep bruxism falls under dental uses, any dentist can order this treatment as it is currently available in the US and Canada.
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