The Luco Hybrid OSA Appliance is the only FDA cleared treatment of sleep related bruxism (K160477). To date, it is the first and only FDA cleared treatment of this common and serious condition.
The design of the Luco Hybrid was refined over 7 years to incorporate a number of features that not only protect the teeth from the forces of sleep related bruxism, but also address the activation of the trigeminal cardiac reflex.
The Patented Forward Bite:
There patented forward bite of the Luco Hybrid precisely places the bite over the upper 1st and second bicuspids. There are a number of reasons for this innovation that make the Luco Hybrid unique in mandibular advancement appliances. This is, by far, the most significant feature of the Luco Hybrid device.
1. Stress Distribution:
When we bite together, this places stress and strain on the skull. There are three types of stress: compression, torsion and shear (figure 2).
When chewing hard foods, compression stress occurs on the teeth and jaws. When chewing side-to-side, there is shear stress on the cusps of the teeth and when eating something sticky or chewy, there is tension stress. In sleep-related bruxism, compression and shear stresses (figure 2) are the most significant. With compression (clenching of the teeth), fillings and ceramic crowns may crack under the pressure, or vertical cracks in the teeth can occur. With shear stress (grinding of the teeth), the cusps of the teeth can fracture, the teeth can loosen or the PDL can be damaged resulting in pain and premature bone loss. Shear stress (grinding of the teeth), is much more common than compression (clenching) during sleep-related bruxism at all levels of severity.
Stress Distribution on the Skull When Biting in the Molar Region:
When biting or contacting in the molar region, there are a number of regions that are placed under excessive stress\force. The following is a stereolythic model of forces when biting in the molar region. Dark blue indicates low stress, green moderate, and red severe.
When biting in the molar region, there are high concentrations of force (noted as red in animation) in the regions of:
- the body of the mandible
- the angle of the mandible
- the coronoid process of the mandible
- the TMJ
- under the eyes
- down the nasal septum
As can be seen in Figure 3, there are very unfavorable stresses associated with a molar bite. Unfortunately, all other mandibular advancement appliances, as well as all upper and lower bruxism appliances, are designed with this type of bite. The FDA, on their guidance for OSA appliances actually list Temporomandibular Joint (TMJ) Dysfunction Syndrome as a an identified risk for OSA appliances, in section 5. This is most likely due to the molar bite being present on all other mandibular advancement and bruxism appliances.
Stress Distribution on the Skull when Biting in the Cuspid Region:
When biting in the cuspid region, the bite force is much more favorable.
As can be seen in figure 4 above, when biting in the cuspid region, there is an even distribution of the bite force through the facial bones. The forward bite of the Luco Hybrid places the bite precisely in this place. The only high stress area (marked in red) is the tip of the cuspid (eyetooth), which is one of the strongest teeth we have.
This is why the Luco Hybrid device does not cause Temporomandibular Joint (TMJ) Dysfunction Syndrome and was originally designed to treat this condition. All other mandibular advancement appliances run the risk of TMD and muscle pain after a few weeks to a month of use. This is why the FDA lists it as an identified risk. This simply does not occur with the Luco Hybrid device.
2. Activation of the Periodontal Masseter Reflex
There is another cranial reflex that is utilized by the patented forward bite of this device, called the periodontal masseter reflex. It is not affected by the HTR2a polymorphism and functions normally in patients suffering from sleep-related bruxism.
The periodontal-masseter reflex is similar to the masseter inhibitory reflex except it does not involve the same pathways. When the periodontal or ligaments surrounding the roots of the 1st bicuspids and cuspids are stimulated, this reflex is activated. To a lesser extent, pressure on the incisors can elicit this response however it is stronger in the cuspid region. It is unique in that it affects both closing and opening muscles (figure 5) in the reflex loop.
The purpose of this reflex is to inhibit contraction of the masseter muscle. It is protective, preventing damage to the teeth, just as the masseter inhibitory reflex does.
The Luco Hybrid device treats the muscle hyperactivity and limits the bite force of sleep-related bruxism by activating this reflex through the forward bite over the upper cuspids and 1st bicuspids.
3. Prevention of Activation of the Trigeminal Cardiac Reflex
An endodontic study demonstrated that root canal therapy on the 1st bicuspids or cuspids resulting in a rapid drop in heart rate and blood pressure, suggesting a novel form of the TCR.
The Luco Hybrid, with its forward bite, supports this and stimulates the conventional parasympathetic stimulation of the TCR that negates the Gasserion ganglion sympathetic stimulation of the TCR known to occur (One is sympathetic, the other parasympathetic. Each has the opposite effect on the cardiovascular system and activation of both simultaneously simply cancels both out).
It should be noted that it is medically accepted that there must be a change in heart rate of greater than 20% from the mean heart rate before a diagnosis of TCR activation may be made. In the sleep tracing of a sleep-related bruxism patient, the heart rate increases from 65 bpm to 94 bpm during the SRB events, a 44% increase. SRB is a significant simulator of the TCR and often increases heart rate by 90 to 100%. In fact, it doesn’t just stimulated the TCR, it hyper-stimulates it. This is the reason sleep-related bruxism has now been shown to be a risk factor for heart disease.
In figure 7, the tracing is from the same patient as in Figure 6 while wearing a Luco Hybrid Device. Note the dramatic improvement in muscle activity, respiration and heart rate.
For more detailed information on the trigeminal cardiac reflex, click here.
The Luco Hybrid’s Effect:
The tracing in Figure 7 is the same patient as in figure 6, while wearing the Luco Hybrid device. The positive effects of PMR activation are clearly demonstrated. This is typical for patients suffering from sleep-related bruxism. When wearing the Luco Hybrid device, respiration normalizes, heart rate returns to normal, blood pressure stabilizes and the sleep bruxism is well controlled.
Please note that sleep-related bruxism is now considered a risk factor for the development of heart disease.
Sleep- related bruxism events result in sleep arousals, this is well known and why it is classified as a sleep disorder. The Luco Hybrid, by reducing or eliminating the sleep- related bruxism events, improves the quality of sleep considerably.
In the development of the Luco Hybrid, it was found to be essential to incorporate the forward bite into the design for the reasons given above. This patented feature and its profound effects are unique to the Luco Hybrid. No other device, including OSA, mandibular advancement, conventional upper or lower night guards can make this claim or demonstrates the above effects.