Dental Indications for the Luco Hybrid OSA Appliance

The Luco Hybrid OSA Appliance is the only OSA appliance that is FDA cleared for both medical and dental indications. For dentistry, the FDA has cleared the following uses:

• For the treatment of sleep bruxism

• To aid in the treatment of associated tension/migraine type headaches

Treating Patients with Sleep Bruxism:
1. Diagnosis:
The American Academy of Sleep Medicine’s International classification of sleep disorders [3rd edition] have defined a diagnostic criteria that must be met before a diagnosis of sleep bruxism can be made.
 The first criteria is the presence of a regular or frequent tooth grinding sounds occurring during sleep.
 The second criteria is the presence of transient morning jaw muscle pain or fatigue; and/or temporal headache; and/or jaw locking upon waking consistent with above reports of tooth grinding during sleep.
These two criteria would be reported by the patient or collected during a review of medical history.
Dentists are in the unique position of diagnosing his condition because they work on a daily basis with the effects of sleep bruxism. Because of the extreme forces generated during sleep bruxism events lasting minutes in some instances it is common to see damage to the teeth, periodontium, musculature and TMJ. TMD patients often suffer from sleep bruxism.

Damage to the teeth can present as excessive wear of cusps of teeth, fractured cusps of teeth, painful abfraction lesions at the cervical junction, vertical cracks in teeth, accelerated periodontal bone loss, premature failure of restorations, accelerated shifting and tipping of teeth, and hypersensitivity of the teeth to temperature extremes. The development of changes to the jaw bones is common including the formation of mandibular and maxillary tori, antigonial notching of the mandible, and coronoid elongation. Degenerative changes in the TMJ can also occur or be accelerated.

The musculature is always affected and it is very common to find sleep bruxism patients demonstrating myofascial trigger points in the masseter and temporalis muscles, to the two muscles involved in sleep bruxism. Decreased range of motion of the mandible is another common sign of sleep bruxism. One of the most diagnostic signs that a dentist can recognize for sleep for the presence of sleep bruxism, is a vibration of the lower jaw when the incisors are very lightly touched together [orofacial dyskinesia]. When a patient presents with orofacial dyskinesia it is almost a certainty suffer from sleep bruxism. Every patient examined should be tested for orofacial dyskinesia to ensure that sleep bruxism patients are not overlooked.

2. Classification of Sleep Bruxism:
Sleep bruxism maybe primary otherwise terms idiopathic or maybe secondary related to some medical disorder disorders. The primary form is the most common in healthy children and adults but secondary may occur in children with cerebral palsy or mental retardation. It may occur in adults with abnormal movements such as oral mandibular myoclonus/facio-mandibular myoclonus or was sleep-related breathing disorders. Sleep bruxism occurs 80% of the time concurrent with sleep apnea, with the sleep bruxism events coordinating with apnea events occurring either slightly before, at the same time, slightly after the apnea events.

Because sleep bruxism is a true sleep disorder and sleep arousals are associated with it we would expect to see daytime sleepiness. Conducting an Epworth sleepiness scale on these suspected patients should be part of your standard routine. Sleep bruxism Epworth Sleepiness Scale scores fall between the 5 and 9 range, slightly below sleep apnea but still much greater than normal. Of note: patients with mild to moderate sleep bruxism often present with higher muscle pain levels.
An international sleep experts have proposed a sub classification for sleep bruxism. They recommend the following three classifications:

Possible sleep bruxism: this is based on self-report, by means of questionnaires, and/or the anamnestic part of the clinical exam

Probable sleep bruxism: this is based upon self-report and supportive physical findings as discussed above

Definitive sleep bruxism: is based upon self-report, physical findings, and a poly sonographic recording, preferably with audiovisual recordings.

The AASM note that although poly sonographic is not required for the diagnosis, sleep bruxism, as described in the most recent version of the AASM Manual for the Scoring of Sleep and Associated Events, is ideally recorded with masseter muscle activity with audiovisual signal to increase diagnostic reliability.
Sleep tracing demonstrating sleep bruxism can be an extremely valuable tool when explaining this disease to your patients.

3. Treatment:
Treatment of sleep bruxism, until very recently, did not exist. Because sleep bruxism’s central mediated in the brain and not related to psychological issues, psychotherapy, hypnotherapy, patient counselling, and other psychological therapies are all ineffective in treating sleep bruxism. Certain medications have been tried that were quite effective, however the side effects from these drugs were severe and in some cases life-threatening.

With the FDA clearance of the Luco hybrid OSA appliance for the treatment of sleep bruxism, there is now a safe, reliable and effective treatment for sleep bruxism in adults.
Recent research has shown that a 70% advancement of the mandible with a 4 mm vertical opening is extremely effective at treating sleep apnea [mild to moderate]. Research and sleep bruxism has shown that a 75% advancement with a 2 to 4 mm opening vertically is the most effective position for treating sleep bruxism.

With the Luco hybrid OSA appliance in the treatment of sleep bruxism it is recommended to start all patients at a 75% advancement with enough opening for clearance of the device without excessively opening causing mouth breathing. In patients with deep overbites less opening is required than with patients with minimal overnights. With this in mind it is recommended to use a 2 mm opening for overbites deeper than 50% can usually be treated with a 2 mm opening. Less than that a 4 mm should be considered.

For dentists not familiar with the use of mandibular advancement appliances, it is recommended that a training course be taken, to fully understand their use. For dentists that are familiar with the use of mandibular advancement appliances, there is no modification needed to your current methods. High-quality digital or manual impressions and protrusive bite registration [see above] are required to manufacture these devices.

When inserting the Luco hybrid OSA appliance for the treatment of sleep bruxism, it is imperative to ensure that the bite is equal and balanced and that when the patient slides there mandible forward and back, the wings contact evenly. The patient should report that the device feels comfortable.
Always reappoint the patient in seven days to reassess the progress. If they have any jaw pain persisting, reassess the bite and the wing contacts. Often you will find this is change since the initial appointment to muscles muscle elongation, sometimes occurring more on one side and the other. Some patients will present at seven days symptom-free. Others may require two or three appointments before reaching the symptom-free stage.

The Luco hybrid OSA appliance was designed initially for the treatment of posttraumatic TMD cases. When the prototype designs have the bite shifted forward, it was found that patients responded very well and cases that were taking months were now taking only weeks to treat. I feel that most dentists can achieve the same level of excellence in treatment that I and other dentists have achieved using this device,

Dr. Ken Luco