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-related bruxism
- To aid in the treatment of associated tension/migraine type headaches
This device is intended for adults 18 and over.
The Luco Hybrid is the first FDA cleared treatment of sleep-related bruxism. Various medications have been studied, but to date, all have failed in treating sleep-related bruxism or the side effects were very severe. Similarly, because sleep-related bruxism does not have a psychological component, psychotherapies are ineffective at treating it. Physiotherapy, chiropractic, craniosacral and acupuncture have all been shown to be ineffective in the treatment of sleep-related bruxism.
Botox Injections for Sleep-Related Bruxism
Botulism Toxin (Botox) has been shown to reduce the bite force and symptoms associated with sleep-related bruxism. There is, however, a gradient of effectiveness and repeated use can lessen the effectiveness in some.
After the initial injection, the symptoms gradually improve. The improvement slowly increases until it peaks and then slowly the symptoms return. There are also some significant risks associated with Botox injections that must be taken into account and some patients report discomfort with the injections.
One effective use for Botox is in reducing the hypertrophy or overdevelopment of the masseter muscle. A side effect of Botox is a reduction of muscle mass or size in the injected muscle. If the masseter is hypertrophied or oversized from sleep-related bruxism, Botox injections may have the effect of reducing the size of the muscle.
Botulinum toxin type A is a paralytic neurotoxin whose main action is to inhibit Ach release at the neuromuscular junction. FDA approved for treating blepharospasm, strabismus, hemifacial spasm, cervical dystonia, glabellar lines, and hyperhidrosis, BoNT‐A has been safely used to treat hyperfunctional facial lines, other dystonias, spasticity, and tremor of the head and neck. It does not, however, have FDA clearance for sleep-related bruxism.
The Luco Hybrid OSA Appliance:
The Luco Hybrid device is the only dental device with both medical and dental uses and the only device that is recognized by the FDA for the treatment of patients when sleep apnea and sleep-related bruxism occur together (secondary sleep-related bruxism).
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-related 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-related bruxism. They do not prevent activation of the trigeminal cardiac reflex and the associated increase in heart rate, blood pressure, respiration, and intracranial pressure. Upper night guards may actually affect the airway resulting in increased apnea type events.
The Luco Hybrid OSA Appliance is unique in that it actually significantly reduces the number and the duration of sleep-related bruxism events that occur. It also significantly reduces the activation of the TCR with each event, reducing the strain on the heart. This is while opening the airway treating sleep apnea and snoring. All other dual arch appliances are not FDA cleared for sleep-related bruxism, do not treat sleep-related bruxism and do not stabilize the TCR.
The Luco Hybrid has a cast metal framework made from the same material as a cast partial denture and metal hip replacements. The acrylic allows for simple adjustments chairside for dental work that may be needed at a later date. The images below demonstrate 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 or have a large tongue, you will certainly appreciate this design!
The surface contacting the teeth is acrylic, with the metal framework embedded in the acrylic. This allows easy adult Mehta for new fillings or crowns constructed after the appliance.
The Luco Hybrid OSA Appliance is clinically proven and FDA cleared as the only true treatment of sleep-related bruxism. If you suffer from OSA and sleep-related bruxism, this is the only device that can treat both conditions together. And, if you wear a CPAP and suffer from sleep-related 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-related bruxism falls under dental uses, any dentist can order this treatment and it is currently available in the US and Canada.
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