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38 • sleepreviewmag.com JULY/AUGUST 2015

Company Airway Management Inc Apnea Sciences Dream Systems LLC Glidewell Laboratories Great Lakes Orthodontics Ltd Keller Laboratories Luco Hybrid OSA

Appliance Inc MicroDental Laboratories

Product

myTAP TAP 3 Elite ApneaRx OASYS Hinge Appliance

OASYS with Option for Combination

Therapy Silent Nite sl Herbst Appliance

MPowRx Snoring and Sleep

Apnea Appliance ClearDream

The Luco Hybrid OSA

Appliance MicrO2 Sleep Device

Website www.myTAPappliance.com www.amisleep.com www.apnearx.com www.dreamsystemsdentallab.

com www.oasyssleep.com www.glidewelldental.com www.greatlakesortho.com www.greatlakesortho.com www.kellerlab.com www.lucohybridosa.com www.micro2sleepdevice.com

Warranty (days) 90 (30-day satisfaction guar-

antee)

365 (for parts)

(60-day satisfaction guarantee)

30 (guarantee with full refund);

90 (replacement) 365 365 182 (if the failure is due to defects

in materials or workmanship)

90 (metal component); 365 (body

material) N/A 365 1,695 730

INDICATIONS

Mild to

Moderate OSA X X X X X X X X X X

Severe OSA X X X

Snoring X X X X X X X X X X X

Bruxism X X X

TYPE

Custom

X X X X X X X X

Noncustom

X X

Boil and Bite

X X

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.

The TAP 3 Elite 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.

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 mandi-

ble, the nasal dilators improve nasal

breathing, and the tongue buttons

improve tongue position, plus a re-

movable bracket can be added for

combination therapy with CPAP.

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.

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.

Fitting Description

myTAP can be fit by a clinician or

assistant in as little as 15 minutes,

allowing you to provide same-day

treatment and immediate relief.

Defined by accurate molding

capabilities, the sleek Precision-Fit

trays allow myTAP to fit effortlessly

on the teeth while instantly creating

a comfortable, low-profile fit.

Because they can be reheated and

refit, Precision-Fit trays can be

adjusted immediately for maximum

comfort. The AM Aligner morning

repositioner, included with each

myTAP, should be fit during the

same appointment.

TAP empowers patients to fine-

tune treatment at home, as well

as work with the clinician to

achieve the best results. With a

single point of central adjustment,

the TAP prevents uneven bilateral

adjustment that may create an

irregular bite and jaw discomfort.

Initial protrusion is set during the

fitting process and easily modified.

Three different hook sizes allow

for greater range of adjustment

with minimal hardware. Posterior

stops may be added for comfort.

With the fixed mechanical hinge

and inseparable pivot point, all TAP

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.

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

required. The hard acrylic snaps

into place. When requested,

retention clasps can be added.

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 lingual-

less 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.

Adjustment

Description

The myTAP is a midline advance-

ment 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 ad-

justment 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.

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.

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.

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 hard-

ware; 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.

Upper tray: soft polyurethane

inner layer and a hard copoly-

ester 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.

Chrome cobalt, methyl methac-

rylate, stainless steel.

Pre-polymerized, milled poly-

methylmethacrylate (PMMA).

Recommended Cleaning

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 non-

alcoholic denture cleaner can be

used for 15 minutes.

Brush gently with soft toothbrush

and anti-bacterial soap. Use non-

alcohol denture cleaner for 15

minutes. Air dry.

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.

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.

Clean daily using a soft tooth-

brush with mild toothpaste or

mild detergent. Do not soak.

Store in dry container.

Peer-reviewed Study

Not provided (however, technol-

ogy 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 Not provided Not provided Not provided Journal of Sleep 2006 Sleep Breath 2008 Not provided Not provided

Case report to be published in

Dental Sleep Practice, Summer

2015, p 24-27.

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

Company Airway Management Inc Apnea Sciences Dream Systems LLC Glidewell Laboratories Great Lakes Orthodontics Ltd Keller Laboratories Luco Hybrid OSA

Appliance Inc MicroDental Laboratories

Product

myTAP TAP 3 Elite ApneaRx OASYS Hinge Appliance

OASYS with Option for Combination

Therapy Silent Nite sl Herbst Appliance

MPowRx Snoring and Sleep

Apnea Appliance ClearDream

The Luco Hybrid OSA

Appliance MicrO2 Sleep Device

Website www.myTAPappliance.com www.amisleep.com www.apnearx.com www.dreamsystemsdentallab.

com www.oasyssleep.com www.glidewelldental.com www.greatlakesortho.com www.greatlakesortho.com www.kellerlab.com www.lucohybridosa.com www.micro2sleepdevice.com

Warranty (days) 90 (30-day satisfaction guar-

antee)

365 (for parts)

(60-day satisfaction guarantee)

30 (guarantee with full refund);

90 (replacement) 365 365 182 (if the failure is due to defects

in materials or workmanship)

90 (metal component); 365 (body

material) N/A 365 1,695 730

INDICATIONS

Mild to

Moderate OSA X X X X X X X X X X

Severe OSA X X X

Snoring X X X X X X X X X X X

Bruxism X X X

TYPE

Custom

X X X X X X X X

Noncustom

X X

Boil and Bite

X X

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.

The TAP 3 Elite 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.

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 mandi-

ble, the nasal dilators improve nasal

breathing, and the tongue buttons

improve tongue position, plus a re-

movable bracket can be added for

combination therapy with CPAP.

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.

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.

Fitting Description

myTAP can be fit by a clinician or

assistant in as little as 15 minutes,

allowing you to provide same-day

treatment and immediate relief.

Defined by accurate molding

capabilities, the sleek Precision-Fit

trays allow myTAP to fit effortlessly

on the teeth while instantly creating

a comfortable, low-profile fit.

Because they can be reheated and

refit, Precision-Fit trays can be

adjusted immediately for maximum

comfort. The AM Aligner morning

repositioner, included with each

myTAP, should be fit during the

same appointment.

TAP empowers patients to fine-

tune treatment at home, as well

as work with the clinician to

achieve the best results. With a

single point of central adjustment,

the TAP prevents uneven bilateral

adjustment that may create an

irregular bite and jaw discomfort.

Initial protrusion is set during the

fitting process and easily modified.

Three different hook sizes allow

for greater range of adjustment

with minimal hardware. Posterior

stops may be added for comfort.

With the fixed mechanical hinge

and inseparable pivot point, all TAP

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.

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

required. The hard acrylic snaps

into place. When requested,

retention clasps can be added.

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 lingual-

less 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.

Adjustment

Description

The myTAP is a midline advance-

ment 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 ad-

justment 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.

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.

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.

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 hard-

ware; 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.

Upper tray: soft polyurethane

inner layer and a hard copoly-

ester 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.

Chrome cobalt, methyl methac-

rylate, stainless steel.

Pre-polymerized, milled poly-

methylmethacrylate (PMMA).

Recommended Cleaning

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 non-

alcoholic denture cleaner can be

used for 15 minutes.

Brush gently with soft toothbrush

and anti-bacterial soap. Use non-

alcohol denture cleaner for 15

minutes. Air dry.

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.

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.

Clean daily using a soft tooth-

brush with mild toothpaste or

mild detergent. Do not soak.

Store in dry container.

Peer-reviewed Study

Not provided (however, technol-

ogy 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 Not provided Not provided Not provided Journal of Sleep 2006 Sleep Breath 2008 Not provided Not provided

Case report to be published in

Dental Sleep Practice, Summer

2015, p 24-27.

40 • sleepreviewmag.com JULY/AUGUST 2015

Company Myerson OravanOSA Quali-Som LLC ResMed SML–Space Maintainers

Laboratories SomnoMed Inc SomnoMed Inc Somnowell Inc Tomed Dr. Toussaint GmbH Whole You Inc

Product

Myerson EMA Oravan TheraSom Cast Narval CC

Lamberg–Sleep Well

Appliance

SomnoDent Herbst Advance with

Compliance Recorder SomnoDent Fusion Somnowell Chrome SomnoGuard AP

Whole You Sleep Appliance

Respire Blue

Website www.myersontooth.com www.oravanosa.com www.quali-som.com www.resmed.com/narval www.smlglobal.com www.somnomed.com www.somnomed.com www.somnowell.com/en-us www.tomedcare.com www.wholeyou.com

Warranty (days) N/A 730 1,825 1,095 1,095 365 (non-Medicare);

1,095 (Medicare) 1,095 2,555 365 (against manufacturer’s defects) 365

INDICATIONS

Mild to

Moderate OSA X X X X X X X X X X

Severe OSA 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 X

Noncustom

Boil and Bite

X

How Does the Oral

Appliance Work?

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 hold-

ing it in a protrusive position.

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.

It advances the mandible to open the

airway and hold the jaw in position.

It holds the jaw forward in a non-

laterally displaced position using

an adjustable telescopic Herbst

mechanism. The chrome cobalt

frameworks act as anchorage.

The 2-part SomnoGuard AP repositions

the lower jaw forward and thereby pre-

vents 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 associ-

ated tissues.

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.

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.

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.

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.

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. Acrylic. Acrylic. Chrome cobalt and stainless steel.

Rigid tray walls: rigid polycarbonate;

lining: soft thermal copolymer; stainless

steel adjusting screws.

Acrylic.

Recommended Cleaning

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.

Clean the device every morning after

removing it from the mouth using a soft

toothbrush, but never use toothpaste as

it contains abrasives. SomnoMed recom-

mends 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 tooth-

brush. 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.

Peer-reviewed Study Not provided

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 Not provided Not provided

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 thermo-

plastic mandibular advancement device

for obstructive sleep apnea: outcomes

and practicability. Laryngoscope. 2014

Oct;124(10): 2427–32.

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

JULY/AUGUST 2015 sleepreviewmag.com • 41

Company Myerson OravanOSA Quali-Som LLC ResMed SML–Space Maintainers

Laboratories SomnoMed Inc SomnoMed Inc Somnowell Inc Tomed Dr. Toussaint GmbH Whole You Inc

Product

Myerson EMA Oravan TheraSom Cast Narval CC

Lamberg–Sleep Well

Appliance

SomnoDent Herbst Advance with

Compliance Recorder SomnoDent Fusion Somnowell Chrome SomnoGuard AP

Whole You Sleep Appliance

Respire Blue

Website www.myersontooth.com www.oravanosa.com www.quali-som.com www.resmed.com/narval www.smlglobal.com www.somnomed.com www.somnomed.com www.somnowell.com/en-us www.tomedcare.com www.wholeyou.com

Warranty (days) N/A 730 1,825 1,095 1,095 365 (non-Medicare);

1,095 (Medicare) 1,095 2,555 365 (against manufacturer’s defects) 365

INDICATIONS

Mild to

Moderate OSA X X X X X X X X X X

Severe OSA 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 X

Noncustom

Boil and Bite

X

How Does the Oral

Appliance Work?

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 hold-

ing it in a protrusive position.

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.

It advances the mandible to open the

airway and hold the jaw in position.

It holds the jaw forward in a non-

laterally displaced position using

an adjustable telescopic Herbst

mechanism. The chrome cobalt

frameworks act as anchorage.

The 2-part SomnoGuard AP repositions

the lower jaw forward and thereby pre-

vents 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 associ-

ated tissues.

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.

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.

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.

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.

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. Acrylic. Acrylic. Chrome cobalt and stainless steel.

Rigid tray walls: rigid polycarbonate;

lining: soft thermal copolymer; stainless

steel adjusting screws.

Acrylic.

Recommended Cleaning

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.

Clean the device every morning after

removing it from the mouth using a soft

toothbrush, but never use toothpaste as

it contains abrasives. SomnoMed recom-

mends 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 tooth-

brush. 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.

Peer-reviewed Study Not provided

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 Not provided Not provided

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 thermo-

plastic mandibular advancement device

for obstructive sleep apnea: outcomes

and practicability. Laryngoscope. 2014

Oct;124(10): 2427–32.

Not provided