Luco Hybrid OSA Appliance ~ 1st Ever ~ FDA Approved ~ Treatment for Sleep Bruxism | OSA | UARS | Snoring |

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The Luco Hybrid OSA Appliance
~ 1st Ever ~ FDA Approved ~
~ Treatment for Sleep Bruxism ~
2016 Dentist's Manual
TABLE OF CONTENTS Page
Preamble ------------------------------------------------------------------------------------------------------------------------------------
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2
Indications/Contraindications/Warnings/Precautions ---------------------------------------------------------------------------
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3
History and Examination ----------------------------------------------------------------------------------------------------------------
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3
Impressions ---------------------------------------------------------------------------------------------------------------------------------
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4
Bite Registration
Technique
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4
Important Considerations when Treatment Planning TMD/ Sleep Bruxism Cases ----------------------------------------
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4
Important Considerations when Treatment Planning OSA /Sleep Bruxism Cases ----------------------------------------
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4
Delivery of the Device -------------------------------------------------------------------------------------------------------------------
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5
The 7 Day Check ---------------------------------------------------------------------------------------------------------------------------
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The 14 Day Check -------------------------------------------------------------------------------------------------------------------------
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5
Final Adjustments ------------------------------------------------------------------------------------------------------------------------
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6
If the Patient Relapses -------------------------------------------------------------------------------------------------------------------
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6
Long Term Reassessment/Commitment --------------------------------------------------------------------------------------------
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6
Non-Compliance -------------------------------------------------------------------------------------------------------------------------
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7
Trouble Shooting -------------------------------------------------------------------------------------------------------------------------
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Preamble:
This manual provides a wealth of information on how to treat your patients, whether they have snoring, OSA, sleep
bruxism, tension/migraine type headaches or all of the above concurrently.
As of July 29, 2016, the Luco Hybrid OSA Appliance
became the 1st
ever FDA market cleared treatment for sleep
bruxism (K160477). In fact, it is the only treatment for sleep bruxism anywhere. Many drugs have been tested and
worked, however the side effects were almost life threatening. Hypnosis, acupuncture, psychotherapy have all
failed. Counselling on sleep hygiene, sleep habits also is not effective as it is not a conscious process.
The World Health Organization and the Center for Disease Control both classify sleep bruxism as a true sleep disorder
[ICD-10 G47.63, ICD-10 G47.63 CM], whereas awake bruxism [ICD-10 F43.8, ICD-10 F43.8 CM] is classified as a
psychological disorder. The CDC goes one step further in their classification stating sleep bruxism excludes awake
bruxism and awake bruxism excludes sleep bruxism.
Many etiologies have been proposed for sleep bruxism, but
the current consensus suggests that it is centrally mediated.
This is supported by research that has shown sleep bruxism
events to be a cascade of events affecting other systems
(Table 1) that is modulated deep within the brain and less
affected by the higher brain functions. Rhythmic
movements such as chewing and bruxing are controlled by
central pattern generators (CPG) within the brain.
Mastication (and sleep bruxism) are driven by the
hypoglossal nucleus, which is controlled by the dorsal medullary reticular column (DMRC) and the nucleus of the
tractus solitarius (NTS). To date there is no consensus on the exact mechanism by which sleep bruxism occurs.
What has also been shown is that 80% of sleep bruxism occurs concurrently with sleep apnea, synchronizing bruxism
events with apnea events (occurring either just before, during or just after). With snoring, it often synchronizes with
each snore. With an incidence of 8% in the general population, that is over 25 million people in the USA suffering
the effects of sleep bruxism. And 80% of those (20 million) also suffer the effects of sleep apnea combined with sleep
bruxism. With every sleep bruxism event, heart rate accelerates, sometimes exceeding 135 bpm for 2-3 minutes at
a time. Abfraction lesions, tori, antigonial notching, coronoid elongation, morning headaches and neck pain, tooth
hypersensitivity to temperatures, and cracked teeth and fillings are all due to sleep bruxism. Quality of life can be
seriously affected.
The Luco Hybrid OSA Appliance
now brings to dentistry the ability to treat sleep apnea, UARS, snoring, sleep
bruxism and associated tension/migraine type headaches separately or in any combination. Predictably. It is the only
mandibular advancement appliance with these indications and the ability to improve the patient’s quality of life to
this level.
I am confident that any dentist, not only sleep dentists, can learn to effectively use this device on their severe
grinders, their sleep bruxers, and achieve the level of care that I and many other dentists using this device have been
able to achieve,
Sincerely,
Dr. Ken Luco
Table 1
The Sleep Bruxism Cascade of Events
1. Increased sympathetic-cardiac activity and fast EEG
waves minutes to seconds preceding the bruxism event
2. Jaw muscle contractions either followed by or concurrent
with an increase in blood pressure, heart rate and
ventilation
3. This is generally associated with a sleep arousal
4. Often concludes with a swallow reflex

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Indications for Use: FDA
1. For the treatment of mild to moderate obstructive sleep apnea in adults K130797
2. For the treatment of primary snoring in adults K130797
3. For the treatment of sleep bruxism in adults K160477
4. To aid in the treatment of associated tension/migraine type headaches in adults K160477
Risks Associated with Mandibular Advancement Appliances:
Clinical performance testing has shown that this device addresses the risks identified within Section 5- Risks
to Health of the FDA Guidance Document for Intraoral Devices for Snoring and/or Obstructive Sleep Apnea.
Contraindications for use:
This appliance should not be used on patients diagnosed with central apnea, have severe respiratory
disorders, have loose teeth or advanced periodontal disease or are under the age of 18 years. You should
not use this appliance if the patient has a known allergy to chrome, cobalt or acrylic [methyl methacrylate].
It should be used on patients with poorly controlled epilepsy. It should be used with caution on patients
with hypertrophy of the masseter and/or temporalis muscles (excessively developed muscles as a result of
untreated parafunction/excessive gum chewing). Patients suffering from Fibromyalgia should be treated
with caution (may be treated by dentists with advanced knowledge of this disorder).
Warnings:
Use of this device may cause movement or changes and dental occlusion, and may cause gingival or dental
soreness. It may cause pain or soreness of the temporomandibular joint. It may cause obstruction of oral
breathing and it may cause excessive salivation or dry mouth.
Responsibility:
The prescribing dentist is responsible to ensure that the contraindications, warnings and precautions are
carefully considered before prescribing this treatment. Every case must be assessed individually to
determine what the best and safest course of treatment is. Care should be exercised when using any
mandibular advancement appliance on patients with pre-existing TMJ problems, chronic myofascial pain,
fibromyalgia or have a history of chronic neck and back pain, as this group of appliances can exacerbate
symptoms for some of these patients. Patients who are claustrophobic may not tolerate this or any oral
appliance therapy.
History and examination:
The patient should complete a history of their general health as well as regarding their sleep condition.
Questions should include their history of headaches, traumas such as sports injuries to the head and neck,
motor vehicle accidents etc. as these patients likely have a concurrent neuromuscular condition with their
sleep disorder. TMD, chronic myofascial pain and fibromyalgia all affect how you will go about treating
their sleep disorder. Patients with diabetes and hypothyroidism both are associated with neuromuscular
problems and again should be treated with caution. The Epworth or other scale should be administered.
Once you have reviewed the patient’s history with the patient [and maybe their spouse as well], you are
ready to examine the patient. You should have a dedicated form to record your OSA examination to
ensure consistency in your exams as well as not to miss important information. On our website you will
find downloadable PDF examination forms, patient history forms, and other forms you can use and
customize for your practice.

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Your examination should provide you with the information to determine if the patient has sleep apnea,
sleep bruxism and/or snoring and a detailed history of headaches. This is essential in your treatment
planning.
First and foremost, ensure that your consent form is signed before starting. We recommend you have
your staff clip it to the front of the file or flag clearly on your patient screen so there is no doubt.
Impressions:
Take full arch silicone or vinyl polysiloxane impressions. High-quality alginate impressions may be used
but they must be exceptional. Orthodontic alginate tears less than standard and may be used. Digital
impressions are also acceptable and in many cases offer higher resolution. Check the impressions
carefully to ensure there are no distortions. Retake the impression if not 100% satisfied.
Bite Registrations:
There are many bite registration techniques currently available for mandibular advancement appliances.
Any of these techniques are acceptable for the Luco hybrid OSA appliance. When treating combination
cases such as sleep apnea /sleep bruxism, consideration must be given to the starting position to ensure
that both conditions are being treated concurrently.
Research for sleep bruxism has been sparse as it is an emerging field. There are some studies that have
shown that a 75% advancement is ideal for treating sleep bruxism and reduces the bruxism events
significantly. The pilot study we recently completed for the FDA used this 75% advancement. We were able
to verify that this position effectively reduced the sleep bruxism through home sleep testing with EMG
recording.
The actual technique used is not as important as where the patient is being positioned. This is an important
point because the bite registration ultimately will determine the success of the treatment. For any
mandibular advancement appliance and when treating complex cases such as sleep apnea/sleep bruxism,
this is even more critical. Pre-treatment of sore muscles can go a long way for these cases.
Important considerations when treatment planning TMD/SB patients:
20% of sleep bruxism occurs independent of OSA. Always measure the entire range of motion, not just
protrusive and wide opening. Left, right and protrusive should be roughly equal. If left or right is much less,
you could have a medially displaced disc on the contralateral side of the restriction [left lateral = 3, right =
8, the right disc is medially displaced]. If, on protrusive, the mandible consistently deviates to a side, suspect
an anterior-medial displacement of the disc on the ipsilateral side [a closed lock]. If they are opening less
than 30 mm and cannot move more than 2 to 3 mm left or right, they are a poor candidate for any
mandibular advancement oral appliance. A hard end feel implies a serious disk displacement.
Important considerations when treatment planning OSA patients with sleep bruxism:
A standard rule of thumb is to always treat the sleep bruxism first to alleviate their pain (improves
compliance). For this reason a 75% advancement is recommended from the start. Recent research has
shown that a 70% advancement with 4 mm vertical opening is one of the most effective positions for
treating mild to moderate sleep apnea. By starting the patient at 75% you have more than achieved the
70% ideal positioning. If you follow this guide, treatment planning for sleep bruxism and sleep apnea is
straightforward and predictable. Most of your cases will require less than two follow-up visits for titration
and you will have excellent control of the sleep bruxism and OSA.

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Delivery of the device:
This section goes through a step-by-step guide on the delivery of the device to the patient.
When you receive the device, examine it and try it on the casts for accuracy. Familiarize yourself with the
fit on the casts. If there are missing teeth or tipped molars, there may be a specific line of draw for inserting
and removing the appliance device.
When the patient arrives:
1. Demonstrate the device on the casts for the patient and show them how the upper and lower
articulate
2. Remove the upper from the cast, wet, and then place onto the patient’s upper teeth. Gently press
the pads onto the teeth. Verify that it sits completely and that there is no rocking.
3. Check the retention of the upper; it should be comfortably set on the teeth. The upper does not
need to be excessively tight, only stationary. When both are in place the upper is firmly seated by
the lower. If loose, adjust the ball clasps slightly and retry.
4. Once you’re satisfied with the fit of the upper, removed by pulling down on the pads of the upper.
Set aside safely
5. Wet the lower component and place on the lower teeth. Again, check for rocking and retention.
Adjust the ball clasps until quite snug. The tongue should not be able to lift it.
6. Try both together placing the upper into place first. Insert the lower and, with the patient watching
in a hand mirror, lift the lower so that the pads are touching and the wings are against the upper
right blocks. Then ask the patient to protrude their jaw forward, aligning the lower incisors with
the anterior appliance and then instruct them to gently bite to seat the lower. Both appliances
should now be comfortably seated in the treatment position. To remove the lower, have the
patient bite together on the pads. Placing a finger or thumb under each lower side and holding it
tight against the upper instruct the patient to slowly open their mouth and the teeth will disengage
from the lower appliance. The upper is removed with a finger above each block and gently pulling
down.
7. Check the bite on each side. Using thick bite paper, have the patient tap and grind on each side.
Remove the lower [as above] and check the markings. There should only be contact on the forward
part of the pads and equally on both sides. If not adjust and ask the patient if sides feel balanced.
If not, mark again and readjust until the patient reports both sides are hitting together at the same
time, on the forward part of the bite pads. Important: any molar contact here = pain tomorrow.
8. Check the wing contacts. Have the patient slide forward and back with the appliance in slowly. Ask
them if they feel the wings contacting the adjustment blocks of the upper at the same time or if
only on one side. If one side has more pressure, this is easily adjusted by advancing the adjustment
screw on the side that has less pressure until the pressure is equal.
9. Once these initial adjustments are completed, the patient should report that the appliance feels
very comfortable and balanced. When they clench, there will be no discomfort on the teeth, their
muscles or their TMJ. Reappoint the patient in seven days to reassess their symptoms and the fit
of the appliance.
The 7 day check:
When the patient presents for their seven-day check, have them place their appliance into their mouth and
let it settle for a few minutes.
1. Check the fit
a. It may change due to muscle lengthening [TMD/SB patients] and settling of the appliance.
You should check the tightness to ensure that the appliance is secure when in place. Have
the patient insert and remove the appliance a few times to should ensure they’re doing
it correctly
b. Check their muscles; the masseter and lateral pterygoids are very good indicators. If they
are relaxed, it is likely that the other muscles are relaxed as well.

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2. Ask the patient:
a. Assess their symptoms
i. Epworth sleepiness scale
ii. Other assessment scale(s) that the referring sleep specialist uses
b. Ask them if they have encountered any difficulties with the device and correct
c. Ask if their spouse about reported snoring. If so they must be advanced.
3. Adjust the treatment position if needed:
a. Using a key provided by the lab, turn the adjustment screws of the upper appliance
adjustment block in the direction of the arrow 2 to 4 turns [0.5 to 1 mm] equally.
4. Replace both in the patient’s mouth
a. Check the bite to ensure it is still in balance
b. Have the patient tap and grind on thick bite paper and go through the steps on pages 4
and 5 as needed
5. Once satisfied, reappoint the patient in two weeks
6. Or, if they are asymptomatic, return them to their sleep lab for a confirmation sleep study
The 14 day check:
Go through all of the steps of the seven-day check adjusting and advancing as needed. If they are
asymptomatic, refer them back to their sleep lab for a confirmation sleep study.
Note: it is rare that a patient should need to be seen past 14 days. If you consistently require a longer
titration, please check your technique. You may have skipped an important step. Please retain this
instruction manual for future reference. Many patients will not require any advancement from the initial
positioning, it will adequately treat their condition.
Final adjustments:
The patient has returned to you after successfully undergoing a confirmation sleep study:
It is essential to see the patient at this time so that you can stabilize the adjustment screws for long-term
wear. Adjustment screws over time can (and often do) unwind affecting the treatment position. A very
simple way of locking the appliance is to place a small amount of composite resin into the gap of the screw
and cure there. Ensure that you do not block the small hole on the screw for the adjustment and do not use
any adhesive. In the future, if a titration is required, simply opening the screw will cause the composite
resin to disengage and fall out. Adjust as needed and replace a small amount of composite.
Check the bite on the appliance one more time with thick articulating paper, adjusting as needed. Recheck
the wings are contacting equally when protruding and retruding their jaw. Ask the patient how it feels.
If the patient relapses:
In the event that the patient gains weight or similar and symptoms return, it is easy to adjust the appliance
and relock with composite as needed as above. If extreme, notify the referring sleep doctor immediately.
The long term reassessment/commitment:
It is imperative that the patient be seen by yourself or their regular dentist on a six-month interval to ensure
their teeth and gingival tissues are in good health. It is also imperative that you reassess this patient every
six months to yearly to reassess the effectiveness of the treatment. Have the patient complete an Epworth
sleepiness scale to ensure that they are under 5. Not every patient will respond to this treatment. Better to
know sooner than later and get them into a more effective treatment (CPAP, BIPAP).
Check the device for signs of poor home care and bring these to the patient’s attention. Reinforce to the
patient that you must follow them over time; that this device must be monitored. Instruct them to contact
you immediately if they feel their symptoms have returned. If they have dental work done changing the fit

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or if they cannot wear the device, have them contact you. Reappoint them for their next check in 6 to 12
months.
Noncompliance:
A quick and easy test to determine if the patient is wearing the device as prescribed is to ask them to place
the device into their mouth without a mirror. If they are wearing it regularly, they will have no difficulty
doing this. If they are not wearing it, they will fumble with it or may confuse the upper and lower
components. If this occurs, reinforced the patient the need for this treatment and your requirement to
notify the sleep specialist for non-compliance. If they seem resistant at this point, it is your responsibility to
contact their sleep specialist and notify them of the patient’s noncompliance.
If the patient does not present for follow-up care, it is your responsibility to contact the referring sleep
specialist and inform them of this. Untreated OSA patients are a much higher risk of personal injury due to
the fatigue, motor vehicle accidents, health problems etc. Never forget that the referring doctor is
overseeing these cases and must be informed of the situations.
Troubleshooting:
No matter how good your impressions and bite registrations are, there will be instances when something
unexpectedly may go wrong and you must find a solution. The following table outlines the most frequent
problems that we have run into over the past 25 years and how to solve them easily. This should save you
time and frustration.
Problem Recommended Mitigation
The patient experiences
tooth soreness
Check the bite carefully and query the patient as to which side touches first. Check that you
don’t have a ball clasp too tight on a tooth. On the lower appliance, tighten the labial bow
slightly and you can sometimes loosen the ball clasp’s on the bicuspids
The patient reports a sore
jaw in the morning
Check there masseter muscles and then recheck the bite carefully. Ensure there are no molar
contacts which will encourage sleep bruxism. Query the patient: are they chewing a lot of gum?
Did they injure themselves biting something hard unexpectedly? Often there is an underlying
cause of jaw pain independent of your treatment. If the bite and wings seem fine, remeasure
the patient’s protrusive movement. Often their muscles will relax allowing a greater range of
movement and your 75% advancement will have been lost. Advance to the new 75%.
The patient reports having a
very dry mouth at night
Instruct the patient to keep a glass of water bedside. They can drink water without removing
the appliance. Suggest Biotene’s or similar products for xerostomia if the problem persists.
The patient drops the
appliance on a hard floor and
bends a wire [very hard to
do]
If you are a proficient wire bender you might be able to undo this. Or you can take new
impressions and send it to the lab for repair. It is near impossible to know exactly where the
wire is distorted.
The tongue is sore on one
side in the morning
This is usually caused by the lower appliance lifting during sleep. Tightening the ball clasps is
usually all that is needed
The lower lifts up when they
open their mouth wide
If you have advanced the appliance 3 to 4 mm ahead of starting position, the curve in the wing
can dislodge the device. The curve at the upper one third of the wing can be straightened which
will help this problem.
The patient reports a sore
neck on waking
Query the patient as to what type of pillow they use and how they sleep. Recommending a good
RMT or PT in the area is often greatly appreciated. Recommend a “side-sleeper” pillow and a
back pad to prevent supine sleep
These are the most common [and actually not that common] concerns
patients may present with and how to address them.
Luco Hybrid OSA appliance Inc.
1419 Butternut Creek Road, Kingston, Ontario K7L 4V3
Tel 613-888 6019 Fax 613 544 7028
Support email: info@lucohybridosa.com www.lucohybridosa.com