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36 • sleepreviewmag.com MAY 2016
Company Advanced Brain Monitoring Inc Airway Management Inc Apnea Sciences BlueSom Dream Systems LLC Glidewell Laboratories Great Lakes Orthodontics Ltd Keller Laboratories Luco Hybrid OSA
Appliance Inc
Product
Apnea Guard dreamTAP ApneaRx BluePro
OASYS with Nasal
Dilators (Optional Tongue
Repositioners) aveoTSD Silent Nite sl Herbst Appliance ClearDream
The Luco Hybrid OSA
Appliance
Website
www.advancedbrainmonitoring.com/
apnea-guard www.tapintosleep.com www.apnearx.com www.bluepro.pro www.
dreamsystemsdentallab.com www.glidewelldental.com www.glidewelldental.com www.greatlakesortho.com www.kellerlab.com www.lucohybridosa.com
Warranty (days)
30 365 (for parts), 60-day satisfaction
guarantee
30 (guarantee with full refund);
90 (replacement) 30 365 180 (replacement if device
defective)
182 (if failure due to defects in
materials or craftsmanship)
90 (metal component);
365 (body material) 365 1,695
INDICATIONS
Mild to
Moderate OSA
X X X Pending X X X X X
Snoring
X X X Pending X X X X X X
Bruxism
X X
TYPE
Custom X X X X X X
Noncustom X X X
Boil and Bite X X
How Does the Oral
Appliance Work?
The Apnea Guard combines a full range
of mandibular advancement with one
of three vertical dimension settings to
define the optimal jaw forward position
for the treatment of obstructive sleep
apnea. The Apnea Guard can serve as
a titration appliance with the optimized
settings transferred to a custom appli-
ance or used as a trial/temporary appli-
ance for up to 30 days.
The dreamTAP advances and stabilizes the
jaw, preventing the tissues of the throat
and tongue from collapsing into the airway.
Advances the mandible in precisely
marked 1 mm increments.
BluePro is a first-step trial device fitted
chair-side by trained dental profession-
als. High performance thermoplastic
provides strong and long-lasting reten-
tion while a discrete titration mechanism
allows for simple self-adjustment and
fine-tuning.
The device repositions the
mandible, the nasal dilators
improve nasal breathing,
and the tongue buttons im-
prove tongue position, plus
a removable bracket can
be added for combination
therapy with CPAP.
Unlike traditional mandibular
advancement devices that
indirectly move the tongue for-
ward by moving the mandible,
the aveoTSD gently suctions
onto the tongue, preventing
it from falling back into the
throat and obstructing the
airway.
Silent Nite sl works by position-
ing the lower jaw forward using
special S-shaped connectors that
are attached to upper and lower
trays, which increases the volu-
metric capacity of the airway.
It works by repositioning and
holding the mandible in a more
protrusive position, thereby
holding the tongue forward and
airway open.
The ClearDream maintains an
open airway using titratable
posterior hardware on the upper
arch, which determines the
amount the mandible and pharyn-
geal tissue are held forward.
Mandibular advancement
moves the tongue and jaw
forward opening and main-
taining the airway. Vertical
wing design prevents retru-
sion when sleeping.
Fitting Description
The Apnea Guard is cleared by the FDA
to be fitted by any trained healthcare
professional.The retention material is
mixed and fitted to the lower teeth into
the bottom tray, followed by fitting of
the upper teeth into the top tray.The
fast-setting retention material enables
these two steps to be completed in
approximately 6 minutes with no spe-
cialized materials (ie, boiling water, etc).
The retention material can be removed
and the fitting repeated if necessary.
All TAP custom products empower patients
to fine-tune treatment at home, as well as
work with the clinician to achieve the best
results. With a single point of midline adjust-
ment, the dreamTAP prevents uneven bilat-
eral adjustment that may create an irregular
bite and jaw discomfort. Initial protrusion is
set during the fitting process and is easily
modified. Three different hook sizes allow for
the greatest range of adjustment (15 mm)
with minimal hardware. Posterior stops may
be added for comfort. All TAP custom de-
vices meet Medicare (E0486) requirements
to treat OSA.
Fitting takes less than 10 minutes.
Submerge in boiled water for 90
seconds. Dip into cup of tap water
for 3 seconds to cool off. Place in
patient’s mouth to custom mold for
30 seconds.
Upper and lower splints are immersed
in boiling water for 1-2 minutes until the
thermoplastic material becomes soft and
clear. Each splint is removed from the
water to cool for 1 minute before fitting
separately to upper and lower arches.
After cooling and setting on the teeth for
4 minutes, the splints are removed and
finished by trimming any excess thermo-
plastic material with a sharp knife. Upper
and lower splints are connected to form
the finished appliance before re-inserting
in the mouth to find the optimal level of
mandibular protrusion to begin therapy.
The Oasys upper splint is
placed. The lower splint with
anterior shield is seated.
If combination therapy is
required, the appliance is
retrofitted to include a re-
movable bracket.
The aveoTSD is available in
three sizes: small, medium,
and large. The medium size
fits 90% of individuals, though
health professionals can
purchase a patient sizing kit to
properly choose a device for
each patient.
It is custom thermoformed in
the laboratory from the patient’s
models. A bite registration taken
with the Slide-Link protrusion
gauge is used to determine
protrusive position and align the
device.
Very few adjustments are re-
quired. The hard acrylic snaps
into place. When requested,
retention clasps can be added.
The ClearDream is custom fab-
ricated from full arch upper and
lower casts, scans, impressions.
Immerse in warm tap water for
10 seconds to moisten before
seating. Insert upper and lower
arch separately, ensuring a gentle,
but snug fit. Next, reinsert the
appliance, starting with the upper,
and have the patient protrude until
they can engage the mandibular
“fins” against the maxillary buccal
pads. Inspect the bite relationship.
Very simple to insert, no
lingual acrylic. Retained by
four small ball clasps per
appliance.
Adjustment
Description
The settings on the Apnea Guard when
inserted in the mouth at the natural/
neutral jaw position and maximum
advancement are used to define
the optimal protrusion. The optimal
advancement is estimated at 70% of
the distance between the neutral and
maximum jaw positions, obtained using
a look-up table.
Adjustment may be made by the patient
with the appliance in the mouth in 1/3 mm
increments. An anterior dial with one point
of adjustment prevents unequal torque. The
clinician teaches a home titration schedule,
which engages the patient in the therapy
process. The dreamTAP may also be easily
adjusted in a sleep lab by the sleep tech
during a study.
Simple patented adjustment
mechanism is unaided by external
accessories (screws, bands, etc).
Provides 1 mm adjustment and lock-
ing capability with a 10 mm range.
A comfortable starting position can be
found under the supervision of a trained
dentist by inserting the device unlocked
into the mouth and moving the lower
jaw. When the optimal level of protru-
sion is found, the device is removed and
locked in position before wearing during
sleep. A titration protocol is recommend-
ed whereby the lower jaw is advanced 1
mm per week if required until symptoms
are relieved.
The anterior shield is on a
sliding/locking system, with
mm guides. Pushing on the
shield increases protrusion/
pulling reduces. Finger
adjustment is used for the
nasal and lingual buttons.
The aveoTSD is not adjustable.
Slide-Link connectors attach to
the upper and lower trays. These
connectors come in six lengths
(21-26 mm) and are easily inter-
changeable by the patient if the
lower jaw needs repositioning.
Small increments using ad-
vancement shims, or up to 5
mm with a 1 mm retrusion
using telescopic hardware.
Titrate with provided adjustment
key, which fits into screws on
each side of the ClearDream’s
maxillary arch. To advance man-
dible forward, move key either up
or down as guided by the arrow to
turn the expansion screw, allow-
ing for titration in as small as 0.1
mm increments with a total range
of 5.5 mm. To move mandible
backwards, move key in the op-
posite direction to the arrow.
Titration is by two orthodontic
screws that are turned with a
key (wire). Adjustable in 0.25
mm adjustments up to 6 mm.
Materials
5.5 grams of catalyst and base reten-
tion material are required to fit the top
or bottom trays of the low, medium, or
high Apnea Guard.
Cobalt chromium hardware, the trays are
made of a durable polymer and the inner
lining is one of two types designated by
the clinician. Triple Laminate is the most
popular, using DuraSoft, which enables
retention by comfortably gripping the teeth.
ThermAcryl is the other option, which
softens when heated to allow reshaping for
patients who are having dental work.
Soft thermal plastic and hard acrylic. Rilsan plastic splints (no latex or BPA)
with thermoplastic lining
Upper: 1.5 mm/2 mm
Vacuform splint; lower:
ThermoFlex hard splint, with
hard acrylic shield, onlays,
and buttons; stainless steel
wire, ball clasps, locks;
Duraloy wire for the nasal
dilators and tongue buttons,
plastic bracket and medical-
grade nasal CPAP mask.
Medical-grade silicone.
Upper tray: soft polyurethane
inner layer and a hard copolyester
outer layer, which are BPA-free.
Lower tray: this same dual-lay-
ered material or all hard copoly-
ester (depending on retention).
Standard hard acrylic and soft
version, but can be made of
Variflex, a thermo-active option.
Keller's clinically unbreakable
Clear 450 Acrylic. Available with
a thermo-adaptive lining for ease
of insertion and increased patient
comfort.
Chrome cobalt, methyl meth-
acrylate, stainless steel.
Recommended Cleaning
Rinse with cold water and air dry.
Clean thoroughly after each use with a
regular soft toothbrush, mild soap, and
cool water. Always rinse thoroughly and
allow to air dry before storing in the
container.
Clean daily with soft toothbrush and
toothpaste.
Daily cleaning with cold water and soft
toothbrush. Regular soaking in a steril-
izing solution.
Brush gently with soft
toothbrush and anti-bacterial
soap. Use non-alcohol den-
ture cleaner for 15 minutes.
Air dry.
Rinse daily in hot water. Once
a week, the aveoTSD should
be given a thorough wash.
Rinse well with water before and
after use and store dry. Clean
appliance with soap and warm
water only.
Use of DentaSOAK is recom-
mended along with toothbrush
and toothpaste daily. Must be
stored dry.
Clean after each use with mild
soap and water. Store dry. Do
not use toothpaste, alcohol, or
alcohol-based products.
Clean with liquid soap and a
soft toothbrush.
Peer-reviewed Study
Not provided
Hoekema A, Stegenga B, et al.
Obstructive sleep apnea. Journal of
Dental Research. 2008;87(9):882-887.
Not provided
Braem M. In vitro retention of a new
thermoplastic titratable mandibular
advancement device. F1000Res. 2015
Feb 26;4:56. doi: 10.12688/f1000re-
search.6061.1. eCollection 2015.
Not provided Not provided Not provided Journal of Sleep 2006 Not provided Not provided
Information for this guide based on data submitted by product manufacturers. Sleep Review strives for accuracy in all data but cannot be
held responsible for claims made by manufacturers. Manufacturers were specifically asked to provide FDA-cleared indications only.
ORAL APPLIANCES
MAY 2016 sleepreviewmag.com • 37
Company Advanced Brain Monitoring Inc Airway Management Inc Apnea Sciences BlueSom Dream Systems LLC Glidewell Laboratories Great Lakes Orthodontics Ltd Keller Laboratories Luco Hybrid OSA
Appliance Inc
Product
Apnea Guard dreamTAP ApneaRx BluePro
OASYS with Nasal
Dilators (Optional Tongue
Repositioners) aveoTSD Silent Nite sl Herbst Appliance ClearDream
The Luco Hybrid OSA
Appliance
Website
www.advancedbrainmonitoring.com/
apnea-guard www.tapintosleep.com www.apnearx.com www.bluepro.pro www.
dreamsystemsdentallab.com www.glidewelldental.com www.glidewelldental.com www.greatlakesortho.com www.kellerlab.com www.lucohybridosa.com
Warranty (days)
30 365 (for parts), 60-day satisfaction
guarantee
30 (guarantee with full refund);
90 (replacement) 30 365 180 (replacement if device
defective)
182 (if failure due to defects in
materials or craftsmanship)
90 (metal component);
365 (body material) 365 1,695
INDICATIONS
Mild to
Moderate OSA
X X X Pending X X X X X
Snoring
X X X Pending X X X X X X
Bruxism
X X
TYPE
Custom X X X X X X
Noncustom X X X
Boil and Bite X X
How Does the Oral
Appliance Work?
The Apnea Guard combines a full range
of mandibular advancement with one
of three vertical dimension settings to
define the optimal jaw forward position
for the treatment of obstructive sleep
apnea. The Apnea Guard can serve as
a titration appliance with the optimized
settings transferred to a custom appli-
ance or used as a trial/temporary appli-
ance for up to 30 days.
The dreamTAP advances and stabilizes the
jaw, preventing the tissues of the throat
and tongue from collapsing into the airway.
Advances the mandible in precisely
marked 1 mm increments.
BluePro is a first-step trial device fitted
chair-side by trained dental profession-
als. High performance thermoplastic
provides strong and long-lasting reten-
tion while a discrete titration mechanism
allows for simple self-adjustment and
fine-tuning.
The device repositions the
mandible, the nasal dilators
improve nasal breathing,
and the tongue buttons im-
prove tongue position, plus
a removable bracket can
be added for combination
therapy with CPAP.
Unlike traditional mandibular
advancement devices that
indirectly move the tongue for-
ward by moving the mandible,
the aveoTSD gently suctions
onto the tongue, preventing
it from falling back into the
throat and obstructing the
airway.
Silent Nite sl works by position-
ing the lower jaw forward using
special S-shaped connectors that
are attached to upper and lower
trays, which increases the volu-
metric capacity of the airway.
It works by repositioning and
holding the mandible in a more
protrusive position, thereby
holding the tongue forward and
airway open.
The ClearDream maintains an
open airway using titratable
posterior hardware on the upper
arch, which determines the
amount the mandible and pharyn-
geal tissue are held forward.
Mandibular advancement
moves the tongue and jaw
forward opening and main-
taining the airway. Vertical
wing design prevents retru-
sion when sleeping.
Fitting Description
The Apnea Guard is cleared by the FDA
to be fitted by any trained healthcare
professional.The retention material is
mixed and fitted to the lower teeth into
the bottom tray, followed by fitting of
the upper teeth into the top tray.The
fast-setting retention material enables
these two steps to be completed in
approximately 6 minutes with no spe-
cialized materials (ie, boiling water, etc).
The retention material can be removed
and the fitting repeated if necessary.
All TAP custom products empower patients
to fine-tune treatment at home, as well as
work with the clinician to achieve the best
results. With a single point of midline adjust-
ment, the dreamTAP prevents uneven bilat-
eral adjustment that may create an irregular
bite and jaw discomfort. Initial protrusion is
set during the fitting process and is easily
modified. Three different hook sizes allow for
the greatest range of adjustment (15 mm)
with minimal hardware. Posterior stops may
be added for comfort. All TAP custom de-
vices meet Medicare (E0486) requirements
to treat OSA.
Fitting takes less than 10 minutes.
Submerge in boiled water for 90
seconds. Dip into cup of tap water
for 3 seconds to cool off. Place in
patient’s mouth to custom mold for
30 seconds.
Upper and lower splints are immersed
in boiling water for 1-2 minutes until the
thermoplastic material becomes soft and
clear. Each splint is removed from the
water to cool for 1 minute before fitting
separately to upper and lower arches.
After cooling and setting on the teeth for
4 minutes, the splints are removed and
finished by trimming any excess thermo-
plastic material with a sharp knife. Upper
and lower splints are connected to form
the finished appliance before re-inserting
in the mouth to find the optimal level of
mandibular protrusion to begin therapy.
The Oasys upper splint is
placed. The lower splint with
anterior shield is seated.
If combination therapy is
required, the appliance is
retrofitted to include a re-
movable bracket.
The aveoTSD is available in
three sizes: small, medium,
and large. The medium size
fits 90% of individuals, though
health professionals can
purchase a patient sizing kit to
properly choose a device for
each patient.
It is custom thermoformed in
the laboratory from the patient’s
models. A bite registration taken
with the Slide-Link protrusion
gauge is used to determine
protrusive position and align the
device.
Very few adjustments are re-
quired. The hard acrylic snaps
into place. When requested,
retention clasps can be added.
The ClearDream is custom fab-
ricated from full arch upper and
lower casts, scans, impressions.
Immerse in warm tap water for
10 seconds to moisten before
seating. Insert upper and lower
arch separately, ensuring a gentle,
but snug fit. Next, reinsert the
appliance, starting with the upper,
and have the patient protrude until
they can engage the mandibular
“fins” against the maxillary buccal
pads. Inspect the bite relationship.
Very simple to insert, no
lingual acrylic. Retained by
four small ball clasps per
appliance.
Adjustment
Description
The settings on the Apnea Guard when
inserted in the mouth at the natural/
neutral jaw position and maximum
advancement are used to define
the optimal protrusion. The optimal
advancement is estimated at 70% of
the distance between the neutral and
maximum jaw positions, obtained using
a look-up table.
Adjustment may be made by the patient
with the appliance in the mouth in 1/3 mm
increments. An anterior dial with one point
of adjustment prevents unequal torque. The
clinician teaches a home titration schedule,
which engages the patient in the therapy
process. The dreamTAP may also be easily
adjusted in a sleep lab by the sleep tech
during a study.
Simple patented adjustment
mechanism is unaided by external
accessories (screws, bands, etc).
Provides 1 mm adjustment and lock-
ing capability with a 10 mm range.
A comfortable starting position can be
found under the supervision of a trained
dentist by inserting the device unlocked
into the mouth and moving the lower
jaw. When the optimal level of protru-
sion is found, the device is removed and
locked in position before wearing during
sleep. A titration protocol is recommend-
ed whereby the lower jaw is advanced 1
mm per week if required until symptoms
are relieved.
The anterior shield is on a
sliding/locking system, with
mm guides. Pushing on the
shield increases protrusion/
pulling reduces. Finger
adjustment is used for the
nasal and lingual buttons.
The aveoTSD is not adjustable.
Slide-Link connectors attach to
the upper and lower trays. These
connectors come in six lengths
(21-26 mm) and are easily inter-
changeable by the patient if the
lower jaw needs repositioning.
Small increments using ad-
vancement shims, or up to 5
mm with a 1 mm retrusion
using telescopic hardware.
Titrate with provided adjustment
key, which fits into screws on
each side of the ClearDream’s
maxillary arch. To advance man-
dible forward, move key either up
or down as guided by the arrow to
turn the expansion screw, allow-
ing for titration in as small as 0.1
mm increments with a total range
of 5.5 mm. To move mandible
backwards, move key in the op-
posite direction to the arrow.
Titration is by two orthodontic
screws that are turned with a
key (wire). Adjustable in 0.25
mm adjustments up to 6 mm.
Materials
5.5 grams of catalyst and base reten-
tion material are required to fit the top
or bottom trays of the low, medium, or
high Apnea Guard.
Cobalt chromium hardware, the trays are
made of a durable polymer and the inner
lining is one of two types designated by
the clinician. Triple Laminate is the most
popular, using DuraSoft, which enables
retention by comfortably gripping the teeth.
ThermAcryl is the other option, which
softens when heated to allow reshaping for
patients who are having dental work.
Soft thermal plastic and hard acrylic. Rilsan plastic splints (no latex or BPA)
with thermoplastic lining
Upper: 1.5 mm/2 mm
Vacuform splint; lower:
ThermoFlex hard splint, with
hard acrylic shield, onlays,
and buttons; stainless steel
wire, ball clasps, locks;
Duraloy wire for the nasal
dilators and tongue buttons,
plastic bracket and medical-
grade nasal CPAP mask.
Medical-grade silicone.
Upper tray: soft polyurethane
inner layer and a hard copolyester
outer layer, which are BPA-free.
Lower tray: this same dual-lay-
ered material or all hard copoly-
ester (depending on retention).
Standard hard acrylic and soft
version, but can be made of
Variflex, a thermo-active option.
Keller's clinically unbreakable
Clear 450 Acrylic. Available with
a thermo-adaptive lining for ease
of insertion and increased patient
comfort.
Chrome cobalt, methyl meth-
acrylate, stainless steel.
Recommended Cleaning
Rinse with cold water and air dry.
Clean thoroughly after each use with a
regular soft toothbrush, mild soap, and
cool water. Always rinse thoroughly and
allow to air dry before storing in the
container.
Clean daily with soft toothbrush and
toothpaste.
Daily cleaning with cold water and soft
toothbrush. Regular soaking in a steril-
izing solution.
Brush gently with soft
toothbrush and anti-bacterial
soap. Use non-alcohol den-
ture cleaner for 15 minutes.
Air dry.
Rinse daily in hot water. Once
a week, the aveoTSD should
be given a thorough wash.
Rinse well with water before and
after use and store dry. Clean
appliance with soap and warm
water only.
Use of DentaSOAK is recom-
mended along with toothbrush
and toothpaste daily. Must be
stored dry.
Clean after each use with mild
soap and water. Store dry. Do
not use toothpaste, alcohol, or
alcohol-based products.
Clean with liquid soap and a
soft toothbrush.
Peer-reviewed Study
Not provided
Hoekema A, Stegenga B, et al.
Obstructive sleep apnea. Journal of
Dental Research. 2008;87(9):882-887.
Not provided
Braem M. In vitro retention of a new
thermoplastic titratable mandibular
advancement device. F1000Res. 2015
Feb 26;4:56. doi: 10.12688/f1000re-
search.6061.1. eCollection 2015.
Not provided Not provided Not provided Journal of Sleep 2006 Not provided Not provided
38 • sleepreviewmag.com MAY 2016
ORAL APPLIANCES
Company MicroDental Laboratories MPowrx Health and Wellness
Products 2012 Inc Myerson OravanOSA Oventus Panthera Dental ResMed SML–Space Maintainers
Laboratories SomnoMed
Product
MicrO2 Sleep Device iSleepSound Myerson EMA Oravan Herbst O2Vent
Panthera D-SAD (Digital – Sleep
Apnea Device) Narval CC Lamberg–Sleep Well Appliance
SomnoDent Herbst Advance with
Compliance Recorder
Website
www.micro2sleepdevice.com www.isleepsound.com www.myersontooth.com www.oravanosa.com www.oventus.com.au www.pantherasleep.com www.resmed.com/narval www.smlglobal.com www.somnomed.com
Warranty (days)
1,095 30 N/A 730 1,825 (for titanium mouth guard)
365 (for polymer inserts) 1,825 1,095 1,095 365 (non-Medicare);
1,095 (Medicare)
INDICATIONS
Mild to
Moderate OSA
X X X X X X X X
Snoring
X X X X X X X X
Bruxism
X X X
TYPE
Custom X X X X X X X X
Noncustom X
Boil and Bite
How Does the Oral
Appliance Work?
MicrO2 utilizes vertically mated buccal
posts to advance and hold the man-
dible forward to open the airway.
iSleepSound uses tongue displace-
ment technology to gently and
comfortably solve snoring problems.
By pulling the tongue gently forward,
the device clears blocked airways,
resulting in a quieter, more comfort-
able sleep.
EMA uses interchangeable elastic straps
and posterior bite pads attached to
thermoformed custom trays to allow
gradual advancement of the mandible and
increased vertical opening until treatment
is successful.
The device opens the patient’s airway
through advancement of the mandible
using an adjustable telescopic Herbst
mechanism. Like the Oravan device,
Oravan Herbst has a truly open ante-
rior design, encouraging natural pro-
trusion of the tongue and maximum
patient comfort.
The Oventus O2Vent is a new, custom-
made, comfortable oral device that is
successfully treating snoring and sleep
apnea. It can also treat people with nasal
obstruction equally well as those with
patent nasal airways. The devicein-
cludes a patented airway that is de-
signed to direct the flow of air through to
the back of the throat and bypass nasal,
soft palate, and tongue obstructions.
The appliance uses the posterior
teeth to maintain the lower jaw in a
protruded position. The D-SAD is a
CAD/CAM appliance that offers the
option of Braebon Dentitrac (in some
countries), thus enabling compliance
monitoring.
Narval CC uses an optimized ar-
ticulation method that maintains the
mandible in an advanced position,
opening the upper airway to enable
effective treatment.
It advances the mandible by holding it
in a protrusive position.
The first oral device with compliance
recording (only can be offered by
SomnoMed in its oral devices), it ad-
vances the mandible to open the
airway and hold the jaw in position.
Fitting Description
The MicrO2 consists of a series of
incrementally advanced full arches
that are uniquely lingual-less and
metal free. Dentists must provide
MicroDental Lab with patient impres-
sions or digital scans along with a
repositioning or neuromuscular bite
registration and prescribed advance-
ments. Dentists and patients alike
experience easy and fast insertion due
to the accuracy of the digital design
and milling process.
iSleepSound has been designed as
“one size fits all” and requires no
special fitting by a sleep specialist.
The device fits comfortably between
the lips and teeth and has an aperture
with a bulb for holding the tongue.
Once the bulb is squeezed to reduce
the air volume, a vacuum is formed
that keeps the tongue comfortably
retained within the bulb.
Fit the upper and lower appliances without
the elastic straps to check for comfort and
to make sure there is no gingival impinge-
ment. Check the posterior bite pads for
even occlusion.
The Oravan Herbst is custom fitted to
each patient by a dentist who takes
impressions and bite registration. As a
result of the no anterior coverage, less
clinical chair time is required, and the
Oravan Herbst will not interfere with
any anterior dental cosmetic work.
The clinician takes impressions and bite
registration for the patient, which are
sent to Oventus for manufacturing the
appliance. Scans of the dental models
are loaded into proprietary software to
design the appliance. The bespoke de-
signs are then 3D printed using titanium.
Following polishing and forming the
polymer inserts on the top and bottom,
the appliance is packaged and sent to
the clinician for delivery to the patient.
Compatible with intra-oral scan-
ning technology or regular dental
impressions. Each case is designed
on proprietary software so that reten-
tion can be adjusted individually.
Panthera Dental can work with any
bite and can design the case accord-
ing to any dentists’ requirements.
Narval is a computer-aided design
and computer-aided manufacturing
(CAD/CAM) MRD device, and each
device is fitted specifically to the pa-
tient by their dentist. The dentist will
take an impression—just like they
would for any dental procedure—and
will define the initial amount of pro-
trusion required. The lateral flexibility
allows patients to talk and drink
while wearing the device.
The dentist seats the upper and lower
appliance separately to determine: a
snug and secure fit, patient comfort,
and the ability of the patient to eas-
ily insert and remove the appliance.
Adams clasps adjust to achieve opti-
mal comfort and retention.
The patient will be fitted for the device
by a qualified dental sleep professional.
The dentist will make a model of the
patient’s teeth and take a protrusive
bite registration.
Adjustment
Description
Adjustments are accomplished by
simply removing an arch and inserting
the next arch in the series of advance-
ment arches. Combinations of different
arches add up to a new titration incre-
ment. No screws, mechanisms, or
elastics required.
Some find the device suctions
toostrongly and makes their tongue
sore; suggest they leave a pocket
of air at end of bulb to ease suc-
tion.Others say it does not suction
enough and dislodges their tongue;
suggest a dab of olive oil inside the
bulb to help increase suction. The
third group finds it just right; no ad-
justment suggestions are needed.
The EMA appliance uses 4 different
strengths of elastic straps in 9 different
lengths to gradually titrate the mandible.
The shorter or stronger the strap, the fur-
ther the mandible is advanced.
The Oravan Herbst can be adjusted by
inserting the key into the adjustment
mechanism that is located on the
anterior mandibular component of the
device. Can be advanced in very small
increments, up to 5 mm.
The current FDA-cleared device is not
adjustable. A new, enhanced adjust-
able version is pending 510(k) clear-
ance, which is expected later in 2016.
Adjustment is by way of a screw in the
front section of the device attaching the
upper and lower sections with up to 14
mm of advancement achievable in total
and lateral movement also possible.
Panthera Dental uses a patented
locking mechanism so the rods can
be easily replaced for titration. The
rods will not disengage during sleep
and will not elongate, even in the
case of patients with bruxism. Rods
come in 0.5mm increments and
lengths vary from 18mm to 35mm.
If patients are still experiencing
symptoms at first follow-up, the
dentist will adjust fit by replacing
the flexible, non-metal connecting
rods to adjust fit. Narval CC is easy
to titrate and highly adjustable with
connecting rods that allow for 15
mm of protrusive range at 0.5 mm
increments.
Each patient receives his/her own box
of inserts, which includes a sequence
of numbered protrusive elements that
advance the mandible in 0.5 mm in-
crements. The patient simply pops out
the insert on the upper member and
replaces it with the following insert in
the numbered sequence.
Herbst Advance can easily be adjusted
in 0.1 mm increments by using pro-
vided titration key; gauge protrusive
movement by using the proprietary
visual indicator, giving total control of
their treatment. With an 8 mm range of
calibration, even when starting patients
with a conservative protrusive registra-
tion you can offer patients continuous
therapeutic efficacy.
Materials
Pre-polymerized, milled polymethyl-
methacrylate (PMMA).
Soft, thin, flexible medical grade plas-
tic resin. BPA free.
Completely metal free; the custom trays
are made from a proprietary thermoplastic
and the straps from a latex-free polymer.
Acrylic.
Polished titanium (permanent 3D printed
mouth guard); dental polymer laminate
(customized plastic molds to fit the
teeth).
Type 12 organic polyamide (appli-
ance and rods). This flexible and
lightweight nylon is available through
a CAD/CAM process.
A flexible, lightweight polymer that
is CAD/CAM custom-made for a
patient’s mouth.
Special SML brand sleep appliance
acrylic. Acrylic.
Recommended Cleaning
Clean daily using a soft toothbrush
with mild toothpaste or mild detergent.
Do not soak. Store in dry container.
Clean regularly with any denture/
orthodontic appliance cleaning
solution or tablets. A mix of toothpaste
and water can also be used. Let it
soak for 10 minutes with the cleaning
solution and cold water, swishing it
before taking it out to air dry.
Clean appliance in tepid water with a
toothbrush and toothpaste or soak it in a
denture cleaning solution; no mouthwash.
Clean with cold water and a soft
toothbrush every morning. If one
wishes to use toothpaste to clean
the Oravan Herbst, brush lightly and
thoroughly rinse. Shake dry and store
the device in its container until the
next use.
Wash daily under running water. Twice a
week use an ultrasonic cleaner in warm
water with an effervescent retainer
cleaning tablet.
Prepare the provided solution using
tap water. Soak appliance in solution
during the day. Rinse under fresh
water before use.
Daily cleaning recommended. Rinse
in lukewarm water; clean with a
soft, clean toothbrush. (Do not use
the same toothbrush used to brush
teeth, as toothpaste can damage the
device.) Rinse in lukewarm water, and
dry with a clean paper towel before
putting it back in storage box.
Clean once daily with OAP anti-micro-
bial dental appliance cleaner.
Clean the device every morning after
removing it from the mouth using a soft
toothbrush, but never use toothpaste
as it contains abrasives. SomnoMed
recommends using SomTabs for daily
cleaning of a SomnoDent device.
Peer-reviewed Study
Hu J, Kuhns D, Kim S, Liptak L,
Sheppard L. Case Report: The MicrO2
Sleep Device. Dental Sleep Practice.
Summer 2015:24-7.
Brant R, Dort L. A randomized,
controlled, crossover study of a
noncustomized tongue retaining
device for sleep disordered breathing.
Journal of Sleep and Breathing. 2008
Nov;12(4):369-73.
Sutherland K, et al; on behalf of the
ORANGE-Registry. Oral appliance treatment
for obstructive sleep apnea: an update. J
Clin Sleep Med. 2014;10(2):215-227.
Sutherland K, et al; on behalf of the
ORANGE-Registry. Oral ap pliance
treatment for obstructive sleep
apnea: an update. J Clin Sleep Med.
2014;10(2):215-227.
Not provided Not provided
Vecchierini MF, Attali V, Collet JM, et
al. A custom-made mandibular repo-
sitioning device for obstructive sleep
apnoea-hypopnoea syndrome: the
ORCADES study. Sleep Med. 2015.
Not provided Not provided
MAY 2016 sleepreviewmag.com • 39
Company MicroDental Laboratories MPowrx Health and Wellness
Products 2012 Inc Myerson OravanOSA Oventus Panthera Dental ResMed SML–Space Maintainers
Laboratories SomnoMed
Product
MicrO2 Sleep Device iSleepSound Myerson EMA Oravan Herbst O2Vent
Panthera D-SAD (Digital – Sleep
Apnea Device) Narval CC Lamberg–Sleep Well Appliance
SomnoDent Herbst Advance with
Compliance Recorder
Website
www.micro2sleepdevice.com www.isleepsound.com www.myersontooth.com www.oravanosa.com www.oventus.com.au www.pantherasleep.com www.resmed.com/narval www.smlglobal.com www.somnomed.com
Warranty (days)
1,095 30 N/A 730 1,825 (for titanium mouth guard)
365 (for polymer inserts) 1,825 1,095 1,095 365 (non-Medicare);
1,095 (Medicare)
INDICATIONS
Mild to
Moderate OSA
X X X X X X X X
Snoring
X X X X X X X X
Bruxism
X X X
TYPE
Custom X X X X X X X X
Noncustom X
Boil and Bite
How Does the Oral
Appliance Work?
MicrO2 utilizes vertically mated buccal
posts to advance and hold the man-
dible forward to open the airway.
iSleepSound uses tongue displace-
ment technology to gently and
comfortably solve snoring problems.
By pulling the tongue gently forward,
the device clears blocked airways,
resulting in a quieter, more comfort-
able sleep.
EMA uses interchangeable elastic straps
and posterior bite pads attached to
thermoformed custom trays to allow
gradual advancement of the mandible and
increased vertical opening until treatment
is successful.
The device opens the patient’s airway
through advancement of the mandible
using an adjustable telescopic Herbst
mechanism. Like the Oravan device,
Oravan Herbst has a truly open ante-
rior design, encouraging natural pro-
trusion of the tongue and maximum
patient comfort.
The Oventus O2Vent is a new, custom-
made, comfortable oral device that is
successfully treating snoring and sleep
apnea. It can also treat people with nasal
obstruction equally well as those with
patent nasal airways. The devicein-
cludes a patented airway that is de-
signed to direct the flow of air through to
the back of the throat and bypass nasal,
soft palate, and tongue obstructions.
The appliance uses the posterior
teeth to maintain the lower jaw in a
protruded position. The D-SAD is a
CAD/CAM appliance that offers the
option of Braebon Dentitrac (in some
countries), thus enabling compliance
monitoring.
Narval CC uses an optimized ar-
ticulation method that maintains the
mandible in an advanced position,
opening the upper airway to enable
effective treatment.
It advances the mandible by holding it
in a protrusive position.
The first oral device with compliance
recording (only can be offered by
SomnoMed in its oral devices), it ad-
vances the mandible to open the
airway and hold the jaw in position.
Fitting Description
The MicrO2 consists of a series of
incrementally advanced full arches
that are uniquely lingual-less and
metal free. Dentists must provide
MicroDental Lab with patient impres-
sions or digital scans along with a
repositioning or neuromuscular bite
registration and prescribed advance-
ments. Dentists and patients alike
experience easy and fast insertion due
to the accuracy of the digital design
and milling process.
iSleepSound has been designed as
“one size fits all” and requires no
special fitting by a sleep specialist.
The device fits comfortably between
the lips and teeth and has an aperture
with a bulb for holding the tongue.
Once the bulb is squeezed to reduce
the air volume, a vacuum is formed
that keeps the tongue comfortably
retained within the bulb.
Fit the upper and lower appliances without
the elastic straps to check for comfort and
to make sure there is no gingival impinge-
ment. Check the posterior bite pads for
even occlusion.
The Oravan Herbst is custom fitted to
each patient by a dentist who takes
impressions and bite registration. As a
result of the no anterior coverage, less
clinical chair time is required, and the
Oravan Herbst will not interfere with
any anterior dental cosmetic work.
The clinician takes impressions and bite
registration for the patient, which are
sent to Oventus for manufacturing the
appliance. Scans of the dental models
are loaded into proprietary software to
design the appliance. The bespoke de-
signs are then 3D printed using titanium.
Following polishing and forming the
polymer inserts on the top and bottom,
the appliance is packaged and sent to
the clinician for delivery to the patient.
Compatible with intra-oral scan-
ning technology or regular dental
impressions. Each case is designed
on proprietary software so that reten-
tion can be adjusted individually.
Panthera Dental can work with any
bite and can design the case accord-
ing to any dentists’ requirements.
Narval is a computer-aided design
and computer-aided manufacturing
(CAD/CAM) MRD device, and each
device is fitted specifically to the pa-
tient by their dentist. The dentist will
take an impression—just like they
would for any dental procedure—and
will define the initial amount of pro-
trusion required. The lateral flexibility
allows patients to talk and drink
while wearing the device.
The dentist seats the upper and lower
appliance separately to determine: a
snug and secure fit, patient comfort,
and the ability of the patient to eas-
ily insert and remove the appliance.
Adams clasps adjust to achieve opti-
mal comfort and retention.
The patient will be fitted for the device
by a qualified dental sleep professional.
The dentist will make a model of the
patient’s teeth and take a protrusive
bite registration.
Adjustment
Description
Adjustments are accomplished by
simply removing an arch and inserting
the next arch in the series of advance-
ment arches. Combinations of different
arches add up to a new titration incre-
ment. No screws, mechanisms, or
elastics required.
Some find the device suctions
toostrongly and makes their tongue
sore; suggest they leave a pocket
of air at end of bulb to ease suc-
tion.Others say it does not suction
enough and dislodges their tongue;
suggest a dab of olive oil inside the
bulb to help increase suction. The
third group finds it just right; no ad-
justment suggestions are needed.
The EMA appliance uses 4 different
strengths of elastic straps in 9 different
lengths to gradually titrate the mandible.
The shorter or stronger the strap, the fur-
ther the mandible is advanced.
The Oravan Herbst can be adjusted by
inserting the key into the adjustment
mechanism that is located on the
anterior mandibular component of the
device. Can be advanced in very small
increments, up to 5 mm.
The current FDA-cleared device is not
adjustable. A new, enhanced adjust-
able version is pending 510(k) clear-
ance, which is expected later in 2016.
Adjustment is by way of a screw in the
front section of the device attaching the
upper and lower sections with up to 14
mm of advancement achievable in total
and lateral movement also possible.
Panthera Dental uses a patented
locking mechanism so the rods can
be easily replaced for titration. The
rods will not disengage during sleep
and will not elongate, even in the
case of patients with bruxism. Rods
come in 0.5mm increments and
lengths vary from 18mm to 35mm.
If patients are still experiencing
symptoms at first follow-up, the
dentist will adjust fit by replacing
the flexible, non-metal connecting
rods to adjust fit. Narval CC is easy
to titrate and highly adjustable with
connecting rods that allow for 15
mm of protrusive range at 0.5 mm
increments.
Each patient receives his/her own box
of inserts, which includes a sequence
of numbered protrusive elements that
advance the mandible in 0.5 mm in-
crements. The patient simply pops out
the insert on the upper member and
replaces it with the following insert in
the numbered sequence.
Herbst Advance can easily be adjusted
in 0.1 mm increments by using pro-
vided titration key; gauge protrusive
movement by using the proprietary
visual indicator, giving total control of
their treatment. With an 8 mm range of
calibration, even when starting patients
with a conservative protrusive registra-
tion you can offer patients continuous
therapeutic efficacy.
Materials
Pre-polymerized, milled polymethyl-
methacrylate (PMMA).
Soft, thin, flexible medical grade plas-
tic resin. BPA free.
Completely metal free; the custom trays
are made from a proprietary thermoplastic
and the straps from a latex-free polymer.
Acrylic.
Polished titanium (permanent 3D printed
mouth guard); dental polymer laminate
(customized plastic molds to fit the
teeth).
Type 12 organic polyamide (appli-
ance and rods). This flexible and
lightweight nylon is available through
a CAD/CAM process.
A flexible, lightweight polymer that
is CAD/CAM custom-made for a
patient’s mouth.
Special SML brand sleep appliance
acrylic. Acrylic.
Recommended Cleaning
Clean daily using a soft toothbrush
with mild toothpaste or mild detergent.
Do not soak. Store in dry container.
Clean regularly with any denture/
orthodontic appliance cleaning
solution or tablets. A mix of toothpaste
and water can also be used. Let it
soak for 10 minutes with the cleaning
solution and cold water, swishing it
before taking it out to air dry.
Clean appliance in tepid water with a
toothbrush and toothpaste or soak it in a
denture cleaning solution; no mouthwash.
Clean with cold water and a soft
toothbrush every morning. If one
wishes to use toothpaste to clean
the Oravan Herbst, brush lightly and
thoroughly rinse. Shake dry and store
the device in its container until the
next use.
Wash daily under running water. Twice a
week use an ultrasonic cleaner in warm
water with an effervescent retainer
cleaning tablet.
Prepare the provided solution using
tap water. Soak appliance in solution
during the day. Rinse under fresh
water before use.
Daily cleaning recommended. Rinse
in lukewarm water; clean with a
soft, clean toothbrush. (Do not use
the same toothbrush used to brush
teeth, as toothpaste can damage the
device.) Rinse in lukewarm water, and
dry with a clean paper towel before
putting it back in storage box.
Clean once daily with OAP anti-micro-
bial dental appliance cleaner.
Clean the device every morning after
removing it from the mouth using a soft
toothbrush, but never use toothpaste
as it contains abrasives. SomnoMed
recommends using SomTabs for daily
cleaning of a SomnoDent device.
Peer-reviewed Study
Hu J, Kuhns D, Kim S, Liptak L,
Sheppard L. Case Report: The MicrO2
Sleep Device. Dental Sleep Practice.
Summer 2015:24-7.
Brant R, Dort L. A randomized,
controlled, crossover study of a
noncustomized tongue retaining
device for sleep disordered breathing.
Journal of Sleep and Breathing. 2008
Nov;12(4):369-73.
Sutherland K, et al; on behalf of the
ORANGE-Registry. Oral appliance treatment
for obstructive sleep apnea: an update. J
Clin Sleep Med. 2014;10(2):215-227.
Sutherland K, et al; on behalf of the
ORANGE-Registry. Oral ap pliance
treatment for obstructive sleep
apnea: an update. J Clin Sleep Med.
2014;10(2):215-227.
Not provided Not provided
Vecchierini MF, Attali V, Collet JM, et
al. A custom-made mandibular repo-
sitioning device for obstructive sleep
apnoea-hypopnoea syndrome: the
ORCADES study. Sleep Med. 2015.
Not provided Not provided
40 • sleepreviewmag.com MAY 2016
Company Somnowell Inc Tomed GmbH Whole You Inc
Product
Somnowell Chrome SomnoGuard AP Respire Blue EF
Website
www.somnowell.com/en-us www.tomed.com www.wholeyou.com
Warranty (days)
2,555 365 (against manufacturer’s
defects) 365
INDICATIONS
Mild to
Moderate OSA
X X X
Snoring
X X X
Bruxism
TYPE
Custom X X
Noncustom
Boil and Bite X
How Does the Oral
Appliance Work?
It holds the jaw forward in a
non-laterally displaced position
using an adjustable tele-
scopic Herbst mechanism. The
chrome cobalt frameworks act
as anchorage.
The 2-part SomnoGuard AP
repositions the lower jaw for-
ward and thereby prevents the
collapse of the upper airway.
With the device in place, the
upper airway is wider and the
patient can breathe more eas-
ily without snoring.
The Respire Blue EF maximizes
tongue space by using a thin,
yet strong chrome material on
the lingual and anterior areas.
Fitting Description
The dentist will take accurate
records to include dental im-
pressions and a forward pos-
tured non-laterally displaced
bite. Additionally, the
dentist will take a Facebow
registration so the technician
can mount the records on a
jaw simulator (semi-adjustable
articulator), so the Somnowell
Chrome should work in
harmony with the patient's
jaw joints.
Fitting can be done by doc-
tors or their trained staff in
approximately 15 minutes. No
special accessories needed
apart from a boiling water
bath, a small pair of scissors,
and gripping tongs.
Place the upper piece in first,
and then the lower.
Adjustment
Description
The telescopic Herbst arms
have a fine adjustment/titration
facility. This is achieved by
turning the adjustment nut.
Adjustment of up to 5 mm is
possible. The frameworks can
have minor adjustments made
by the dentist.
The lower jaw can be infi-
nitely repositioned forward
(titration) by any degree up to
about 10 mm by an adjusting
screw inserted into the screw
guide of the lower jaw tray.
Adjustments are quickly and
easily made outside of the
mouth. Protrusion changes
can be done by doctors or
the instructed patients them-
selves.
The adjustment screw allows
advancement up to 6 mm.
Materials
Chrome cobalt and stainless
steel.
Rigid tray walls: rigid polycar-
bonate; lining: soft thermal
copolymer; stainless steel
adjusting screws.
Acrylic and chrome.
Recommended Cleaning
Scrub under clean water with
a toothbrush. Dishwasher safe.
Clean daily with soft tooth-
brush and mild liquid soap or
a liquid denture cleaner. Rinse
and let the device dry in the
open air.
Upon removal the device should
be rinsed and cleaned with
soap and water, using a soft
brush.
Peer-reviewed Study
Ash SP, Smith AM. Chrome co-
balt mandibular advancement
appliances for managing snor-
ing and obstructive sleep ap-
noea. Journal of Orthodontics.
2004;31:295-299.
Banhiran W, Kittiphumwong
P, Assanasen P,
Chongkolwattana C,
Metheetrairut C. Adjustable
thermoplastic mandibular
advancement device for
obstructive sleep apnea:
outcomes and practicabil-
ity. Laryngoscope. 2014
Oct;124(10):2427–32.
Not provided
ORAL APPLIANCES
Dental Sleep Services
Ez Sleep
Ez Sleep is a national provider of home sleep testing
diagnostic services for the medical and dental com-
munity. It has a large array of HST devices from topline
manufacturers and provides baseline and efficacy
testing metrics and 24/7 tech support. Concierge-level
service and data-driven product offerings increase
patient/provider engagement. Over 1,300 active clients
use Ez Sleep Academy online training modules to learn
methods to identify patients and other practice growth
resources. Ez Sleep also provides innovative products
like the Night Shift wearable for positional therapy and
the Apnea Guard trial appliance. Through strategic
partnerships, Ez Sleep offers an end-to-end solution for
practices to screen, test, trial, and treat patients. inqui-
ries@ezsleeptest.com; www.ezsleeptest.com
Rondeau Seminars Ltd
Brock Rondeau, DDS, is a Diplomate of the International
Board of Orthodontics,Diplomate American Board of
Craniofacial Pain, Diplomate-Academy of Clinical Sleep
Disorders Disciplines,Diplomate American Board of
Dental Sleep Medicine, Diplomate American Board
of CraniofacialDental Sleep Medicine,Master Senior
Certified Instructor for theInternational Association for
Orthodontics,and was awarded the Leon Pinker Award
and Duane Stanford Award. His expertise in teaching,
combined with his insatiable thirst for knowledge in
the orthodontic arena, has pushed Rondeau to the top
of the orthodontic/orthopedic lecture circuit. www.
rondeauseminars.com
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