Oral Appliances Guide 082015

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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.

Airway Management Inc

Apnea Sciences

Dream Systems LLC

Product

Website

INDICATIONS

Warranty (days)

TYPE

ORAL APPLIANCES

Company

OASYS with Option for Combination
Therapy

myTAP

TAP 3 Elite

ApneaRx

OASYS Hinge Appliance

www.myTAPappliance.com

www.amisleep.com

www.apnearx.com

www.dreamsystemsdentallab.
com

www.oasyssleep.com

90 (30-day satisfaction guarantee)

365 (for parts)
(60-day satisfaction guarantee)

30 (guarantee with full refund);
90 (replacement)

365

X
X
X

Advances the mandible in
precisely marked 1 mm
increments.

The OASYS T-10 Hinges provide
10 mm advancement, holding the
lower jaw forward during sleep
to open the airway in the back of
the throat. Optional nasal dilators
and tongue lifters available.

The device repositions the mandible, the nasal dilators improve nasal
breathing, and the tongue buttons
improve tongue position, plus a removable bracket can be added for
combination therapy with CPAP.

Mild to
Moderate OSA
Severe OSA
Snoring
Bruxism
Custom

Noncustom

Boil and Bite

How Does the Oral
Appliance Work?

The myTAP advances and
stabilizes the mandible,
preventing the soft tissues of the
throat and tongue from collapsing
into the airway.

Fitting Description

TAP empowers patients to finemyTAP can be fit by a clinician or
tune treatment at home, as well
assistant in as little as 15 minutes,
as work with the clinician to
allowing you to provide same-day
achieve the best results. With a
treatment and immediate relief.
single point of central adjustment,
Defined by accurate molding
the TAP prevents uneven bilateral
capabilities, the sleek Precision-Fit
adjustment that may create an
trays allow myTAP to fit effortlessly irregular bite and jaw discomfort.
on the teeth while instantly creating Initial protrusion is set during the
a comfortable, low-profile fit.
fitting process and easily modified.
Because they can be reheated and Three different hook sizes allow
refit, Precision-Fit trays can be
for greater range of adjustment
adjusted immediately for maximum with minimal hardware. Posterior
comfort. The AM Aligner morning
stops may be added for comfort.
repositioner, included with each
With the fixed mechanical hinge
myTAP, should be fit during the and inseparable pivot point, all TAP
same appointment.
Custom devices meet Medicare
(E0486) requirements to treat OSA.

Fitting takes less than 10
minutes. Emerge 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.

The OASYS Hinge Appliance is
inserted as one piece, placing the
upper splint on the upper teeth
first and then sliding the lower
teeth up into the lower splint.

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
removable bracket.

Adjustment
Description

The myTAP is a midline advancement oral appliance adjustable
by the patient. The adjustment
dial allows the patient to control
the treatment position. With its
incremental advancement (1/4 mm
per half turn) capabilities and its
wide range of adjustment (20 mm
total), the myTAP allows patients
to reach their treatment position
comfortably.

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 TAP 3 Elite 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 locking capability
with a 10 mm range.

Hinges have anterior hex screws
for intra-oral advancement. A
Hex wrench is used to advance in
1/4 mm and 1/2 mm increments
(2 full clockwise turns = 1 mm).
Optional nasal dilators and tongue
lifters are adjusted with the index
fingers and thumbs as needed.

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.

Materials

All-plastic design: a patented
ThermAcryl material over molded
onto a polycarbonate tray. The
patented trays, when heated,
become soft and can be molded
to the teeth at the time of fitting.
If reheated, the trays will return
to their original shape and can
be refit.

Surgical grade stainless steel hardware; the trays have two hard layers
of a durable polymer and 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.

Fricke Vitacrylic ThermoFlex hard
resin/hard acrylic, Duraloy wires,
stainless steel hinges, pivots and
screws; ball clasps/arrow clasps,
latex-tree elastics.

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.

The myTAP should be cleaned
thoroughly after each use with
a regular soft toothbrush and
warm water. Weekly (or less
as needed), clean the trays
with warm water, mild soap,
and a toothbrush. Always rinse
thoroughly and allow to air dry
before storing in the container.

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. The TAP 3 Elite can
be soaked weekly in a diluted
peroxide solution for 5 minutes
if needed.

Clean daily with soft toothbrush
and toothpaste.

Brush carefully with soft
toothbrush and anti-bacterial
soap. Let the device dry during
the day with the lid of the
container left open. A nonalcoholic denture cleaner can be
used for 15 minutes.

Brush gently with soft toothbrush
and anti-bacterial soap. Use nonalcohol denture cleaner for 15
minutes. Air dry.

Not provided (however, technology is based on the custom TAP
appliances, which are validated in
32+ peer-reviewed studies)

Hoekema A, Stegenga B, et al.
Obstructive sleep apnea therapy.
Journal of Dental Research.
2008;87(9): 882-887.

Not provided

Recommended Cleaning

Peer-reviewed
Study
38 • sleepreviewmag.com

The TAP 3 Elite advances and
stabilizes the jaw, preventing the
tissues of the throat and tongue
from collapsing into the airway.

Not provided
JULY/AUGUST
2015

Glidewell Laboratories

Great Lakes Orthodontics Ltd

Keller Laboratories

Luco Hybrid OSA
Appliance Inc

MicroDental Laboratories

Silent Nite sl

Herbst Appliance

MPowRx Snoring and Sleep
Apnea Appliance

ClearDream

The Luco Hybrid OSA
Appliance

MicrO2 Sleep Device

www.glidewelldental.com

www.greatlakesortho.com

www.kellerlab.com

www.lucohybridosa.com

www.micro2sleepdevice.com

182 (if the failure is due to defects
in materials or workmanship)

90 (metal component); 365 (body
material)

N/A

365

1,695

730

X
X

It repositions the tongue forward
instead of relying on the alveolar
ridge or dentition to stay in
place. No impression needed.

The ClearDream maintains an
open airway using titratable
posterior hardware on the
upper arch, which determines
the amount the mandible and
pharyngeal tissue are held
forward.

Mandibular advancement moves
the tongue and jaw forward
opening and maintaining the
airway. Vertical wing design
prevents retrusion when
sleeping.

MicrO2 utilizes vertically mated
buccal posts to advance and
hold the mandible forward to
open the airway.

Comfortable, secure fit.
Maintains shape and one size
fits most.

The ClearDream is custom
fabricated 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.

The MicrO2 consists of a series
of incrementally advanced full
arches that are uniquely lingualless and metal free. Dentists
must provide MicroDental
Lab with patient impressions
or digital scans along with a
repositioning or neuromuscular
bite registration and prescribed
advancements. Dentists and
patients alike experience easy
and fast insertion due to the
accuracy of the digital design
and milling process.

Non-custom, non-adjustable.

Titrate with provided adjustment
key, which fits into screws on
each side of the ClearDream’s
maxillary arch. To advance
mandible forward, move key
either up or down as guided by
the arrow to turn the expansion
screw allowing for titration in
as small as 0.1 mm increments
with a total range of 5.5 mms.
To move mandible backwards,
move key in the opposite
direction to the arrow.

Titration is by two orthodontic
screws that are turned with a
key (wire). Adjustable in 1/4 mm
adjustments up to 6 mm.

Adjustments are accomplished
by simply removing an arch and
inserting the next arch in the
series of advancement arches.
No screws, mechanisms, or
elastics required.

Chrome cobalt, methyl methacrylate, stainless steel.

Pre-polymerized, milled polymethylmethacrylate (PMMA).

Silent Nite sl works by positioning the lower jaw forward using
special S-shaped connectors that
are attached to upper and lower
trays, which increases the volumetric capacity of the airway.

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.

It works by repositioning and
holding the mandible in a more
protrusive position, thereby
holding the tongue forward and
airway open.

Very few adjustments are
required. The hard acrylic snaps
into place. When requested,
retention clasps can be added.

Slide-Link connectors attach
to the upper and lower trays.
These connectors come in six
lengths (21-26 mm) and are
easily interchangeable by the
patient if the lower jaw needs
repositioning.

Small increments using
advancement shims, or up to 5
mm with a 1 mm retrusion using
telescopic hardware.

Upper tray: soft polyurethane
inner layer and a hard copolyester outer layer, which are
BPA-free. Lower tray: this same
dual-layered material or all
hard copolyester (depending on
retention).

Standard hard acrylic and soft
version, but can be made of
Variflex, a thermo-active option.

Elastomer.

Keller's clinically unbreakable
Clear 450 Acrylic. Available with
a thermo-adaptive lining for
ease of insertion and increased
patient comfort.

Rinse well with water before and
after use and store dry. Clean
appliance with soap and warm
water only.

Use of DentaSOAK is recommended 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.

Clean daily using a soft toothbrush with mild toothpaste or
mild detergent. Do not soak.
Store in dry container.

Not provided

Journal of Sleep 2006

Sleep Breath 2008

Not provided

Case report to be published in
Dental Sleep Practice, Summer
2015, p 24-27.

SML–Space Maintainers
Laboratories

Myerson

OravanOSA

Quali-Som LLC

ResMed

Myerson EMA

Oravan

TheraSom Cast

Narval CC

Lamberg–Sleep Well
Appliance

www.myersontooth.com

www.oravanosa.com

www.quali-som.com

www.resmed.com/narval

www.smlglobal.com

N/A

730

1,825

1,095

X
X
X

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 and holding the jaw
in a forward position. The true
open anterior design of the device
encourages natural protrusion of
the tongue and maximum patient
comfort.

The TheraSom Cast works
by moderate mandibular
advancement coupled with
increased lingual and protrusive
space, thus increasing the
opening of the airway at the back
of the throat.

Narval CC uses an optimized
articulation 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.

Fitting Description

Fit the upper and lower
appliances without the elastic
straps to check for comfort
and to make sure there is no
gingival impingement. Check
the posterior bite pads for even
occlusion.

The Oravan is custom
fitted to each patient by a
professional sleep dentist by
taking impressions and a bite
registration. The Oravan’s
separate top and bottom acrylic
pieces allow patients complete
comfort and the freedom to open
and close their mouth and lips,
speak clearly, yawn, and drink.
As a result of the no anterior
coverage, less clinical chair time
is required, and the Oravan will
not interfere with any anterior
dental cosmetic work.

The TheraSom Cast is fit by a
professional in about 30 minutes,
and is done in the same way a
dentist fits a cast partial. The
protrusion is achieved using a
spring attached to each hook
on the maxillary portion of the
appliance and then to one of
four corresponding hooks on the
mandibular portion.

Narval is a computer-aided
design and computer-aided
manufacturing (CAD/CAM) MRD
device, and each device is fitted
specifically to the patient by their
dentist. The dentist will take an
impression—just like they would
for any dental procedure—and
will define the initial amount of
protrusion 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 easily insert and
remove the appliance. Adams
clasps adjust to achieve optimal
comfort and retention.

Adjustment
Description

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 further the mandible
is advanced.

The Oravan can be titrated by
inserting the titration key into the
adjustment mechanism that is
located on the posterior maxillary
component of the device. Each
turn in the direction of the arrow
moves the appliance forward
0.1 mm.

The TheraSom Cast is adjusted
in 1.25 mm increments by
attaching one of three springs of
different lengths to the hook on
the maxillary portion and from
there to one of the four hooks on
the mandibular portion. It is not
necessary to move the mandible
forward so far that the patient
experiences any discomfort.

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 increments.
The patient simply pops out the
insert on the upper member and
replaces it with the following
insert in the numbered sequence.

Materials

Completely metal free; the
custom trays are made from a
proprietary thermoplastic and
the straps from a latex-free
polymer.

Acrylic.

Vitallium, a dental alloy that has
been in use for over 60 years;
stainless steel springs.

A flexible, lightweight polymer
that is CAD/CAM custom-made
for a patient’s mouth.

Special SML brand sleep
appliance acrylic.

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, brush lightly and
thoroughly rinse. Shake dry and
store the device in its container
until the next use.

Clean each morning using a
firm toothbrush and can also be
cleaned by soaking it in an over
the counter denture cleaner.
It’s even possible to put the
appliance into the dishwasher.

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-microbial dental appliance
cleaner.

Not provided

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.

Not provided

Product

Website

INDICATIONS

Warranty (days)

TYPE

ORAL APPLIANCES

Company

Mild to
Moderate OSA
Severe OSA
Snoring
Bruxism
Custom
Noncustom
Boil and Bite

How Does the Oral
Appliance Work?

Recommended Cleaning

Peer-reviewed Study

40 • sleepreviewmag.com

JULY/AUGUST 2015

SomnoMed Inc

Somnowell Inc

Tomed Dr. Toussaint GmbH

Whole You Inc

SomnoDent Herbst Advance with
Compliance Recorder

SomnoDent Fusion

Somnowell Chrome

SomnoGuard AP

Whole You Sleep Appliance
Respire Blue

www.somnomed.com

www.somnowell.com/en-us

www.tomedcare.com

www.wholeyou.com

365 (non-Medicare);
1,095 (Medicare)

1,095

2,555

365 (against manufacturer’s defects)

365

X
X

The first oral device with compliance
recording (only can be offered by
SomnoMed in its oral devices), it
advances the mandible to open the
airway and hold the jaw in position.

The 2-part SomnoGuard AP repositions
the lower jaw forward 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 easily without snoring.

The device opens the patient's airway
by advancing the jaw and the associated tissues.

It advances the mandible to open the
airway and hold the jaw in position.

It holds the jaw forward in a nonlaterally displaced position using
an adjustable telescopic Herbst
mechanism. The chrome cobalt
frameworks act as anchorage.

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.

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.

The dentist will take accurate records
to include dental impressions and
a forward postured 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 doctors 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.

The upper and lower components are
not connected, so this freedom allows
the patient to place one component at
a time. This also allows the patient to
open and close their mouth during the
night, which should increase patient
acceptance and comfort. The device
can be prescribed only by a doctor
and should take only a few minutes
to insert.

Herbst Advance can easily be adjusted
in 0.1 mm increments by utilizing our
provided titration key; you can easily
gauge protrusive movement by using
our proprietary visual indicator, giving
you and your patients total control of
their treatment. With an 8 mm range
of calibration, even when starting
patients with a conservative protrusive
registration you can offer your patients
continuous therapeutic efficacy.

The SomnoDent Fusion is advanced
in 1 mm increments by changing the
wings on the lower device or more
precisely by adjusting the screw in
0.1 mm increments using the screw
on the top device. The SomnoDent
Fusion offers a custom 8.5 mm range
of calibration, reducing the need for
device resets.

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 infinitely
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 themselves.

An adjustment key is provided to
advance the screw inside of the
device. This, in turn, advances the jaw
in 0.2 mm increments, and up to 6
mm in full advancement. There is an
arrow inside of the device indicating
which direction to turn the screw and
videos to show this can be provided.

Acrylic.

Chrome cobalt and stainless steel.

Rigid tray walls: rigid polycarbonate;
lining: soft thermal copolymer; stainless
steel adjusting screws.

Acrylic.

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.

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.

Scrub under clean water with a toothbrush. Dishwasher safe.

Clean daily with soft toothbrush and
mild liquid soap or a liquid denture
cleaner. Rinse and let the device dry in
the open air.

Clean with soap and water every
morning. It’s recommended to use a
denture/retainer cleaner once a week.

SomnoMed SomnoDent Fusion
Obstructive Sleep Apnea Device. Dental
Product Shopper 2015. 9(6):72-3.

Ash SP, Smith AM. Chrome cobalt
mandibular advancement appliances
for managing snoring and obstructive
sleep apnoea. 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 practicability. Laryngoscope. 2014
Oct;124(10): 2427–32.

Not provided

JULY/AUGUST 2015

sleepreviewmag.com • 41

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