The mandible, normally held by the action of the muscles, in fact tends to move backwards during sleep, its movement causing the tongue to move towards the back of the mouth and thus the size of the upper air tract to diminish.
Sometimes, especially with individuals suffering from macroglossia or from a small-size mouth cavity, or if the laxity of the tissues is high, the obstruction of the
breathing canal can be serious or even complete, causing in fact the
breathing to be interrupted or
obstructive sleep apnea.
This solution however places an excessive constraint upon the wearer and requires individual calibrations for each patient, as well as polysomnographic efficiency controls.
For these reasons, the application of this type of treatment is restricted to obstructive syndromes and is not justified for treating simple snoring.
Prolonged use is likely for the treatment to cause nasal symptoms of the rhinitis type or
skin sores that make it impossible to wear the
mask.
This solution is however invasive and painful, and the resulting improvement is only transitory.
Furthermore, it can involve changes of the mouth morphology that can disturb deglutition.
This highly invasive operation is nowadays practically abandoned.
Having the mandible immobilized can prove discomforting for the wearer, notably in that it interferes with deglutition and can cause an algo-dysfunctional syndrome (ADS) of the temporo-mandibular joint (TMJ).
The adaptability of known thermoformable devices is very limited and they cannot adapt to the full range of possible conformations.
When the mouth appliance cannot adapt perfectly to the individual dental conformation, the efficiency is reduced, the device is instable, there are excessive tensions on the
dentition and the
adaptation of the
system is very uncomfortable.
Furthermore, following the involuntary movements of clamping the mandible, high and concentrated mechanical efforts can occur on the trays' semi-rigid elements that can cause the device to rupture.
Another limitation of this type of appliances is that if it does not adapt perfectly to the dental conformation, it can, during use, exert lateral forces on the teeth that can be of
high intensity.
These lateral forces can, in time, lead to a displacement and destabilization of the teeth and to their definitive loss.
Another limitation of the known mandibular devices, such as for example the devices described by EP0845962B, that allow a certain freedom of movement of the mandible, is that the latter can, following involuntary movements during sleep, abandon the forward advanced position.
The device then completely loses its efficiency.
The wearer's position during sleep can also influence negatively the good functioning of the known mandibular devices.
Once these phases of agitated sleep over, the prior art devices are not always capable of automatically bringing the mandible in the advanced therapeutic position.
Another limitation of the known devices capable of being personalized is that they are based on a conventional mouth geometry where the teeth are parallel and arranged on two plane arches.
These splints are not capable of adapting to most real dental conformations.