Oral Appliances for Snoring and Obstructive Sleep Apnea

Oral Appliances for Snoring, UARS
and Obstructive Sleep Apnea
Bruce W. Roman, DDS
Diplomate, American Board of Orthodontics
Diplomate, American Board of Dental Sleep Medicine
500 SE Douglas Ave…Roseburg, OR…541.672.5721…beautifulsmiles@mindspring.com…www.SmilesByRoman.com

© 2014 Bruce W. Roman, DDS, D. ABDSM
What is SDB (Sleep-Disordered
Breathing) and how big a problem is it?
SDB includes snoring, Upper Airway Resistance Syndrome
(UARS), sleep apnea and the obesity-related hypoventilation
syndrome.
Young, et al, in a 2002 article in AJRCCM, Epidemiology of
OSA: a population health perspective, concluded:
“SDB is being increasingly recognized as a cause of
substantial morbidity and mortality. Approximately 9% of
women and 24% of men have SDB and a majority of
those remain undiagnosed.”

Pathophysiology of Snoring and
Obstructive Sleep Apnea

What is snoring?
Snoring is sound waves caused by
vibrations, just as our vocal cords vibrate
to form sound waves that we call our
voice.

Where do the vibrations come from?
As you fall asleep, the
soft tissues at the back
of the throat, the
muscles that line the
airway, the soft palate,
uvula and the tongue,
relax.
The tongue then drops
back into the airway,
causing it to narrow.
As air passes through
this narrower airway, it
moves faster and causes
the tissues to vibrate.

Is snoring really a problem?
• Just ask the bed partner…they’ll tell you!!!
• 27-31% of all married couples sleep in
separate rooms with snoring being a
principal reason.
• With loud snoring, even other household
members can be effected. And they don’t
like it any more than the bed partner.

Bed Partners’ and Patients’ Experiences after Treatment of
OSA with an Oral Appliance; Tegelberg, et al., Swed Dent J
2012:
• Both patients and bed partners reported
improvement in general well-being, physical
strength and mental energy (70-80% for
patients; 55-68% for bed partners).”
• Conclusions: “In all dimensions, the
treatment effect had a great influence, not
only on patients but on bed partners as
well.”

What about “heavy” snoring?
A study published in the September, 2008
issue of SLEEP, Heavy Snoring as a Cause of
Carotid Artery Atherosclerosis, concluded:
“Heavy snoring (defined as more than 50%
of the night) significantly increases the risk
of carotid atherosclerosis (“hardening of the
arteries”), and the increase is independent
of other risk factors.”

What is UARS?
• Upper Airway Resistance Syndrome (UARS) is a sleep
condition in which there is airway resistance to
breathing. Breathing becomes labored. It is similar to
trying to breathe through a thin straw.
• The increased upper airway resistance in UARS does not
lead to a stoppage of airflow (apnea) or decrease in
airflow (hypopnea), but instead leads to an arousal due
to the increased work of breathing to overcome the
resistance. Repeated and multiple arousals (which the
patient is usually unaware of) result in fragmented and
non-restorative sleep.
• The primary UARS symptoms include snoring, daytime
sleepiness and excessive fatigue.

What is Sleep Apnea?
There are three types of sleep apnea:
1) Central
2) Obstructive
3) Complex or Mixed

Central Sleep Apnea
Central sleep apnea occurs when the brain
fails to send the appropriate signals to the
breathing muscles to initiate respirations.

Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is a sleep-related
breathing disorder that involves a RERA
(respiratory effort-related arousal), decrease
(hypopnea) or complete halt (apnea) in
breathing despite an ongoing effort to breathe.

Complex or Mixed Sleep Apnea
Mixed sleep apnea is a combination of both
central sleep apnea and obstructive sleep
apnea.

• If your oxygen level drops low enough—
and if you are experiencing an apnea, it
will—your brain sends a signal to the
muscles in the airway to contract.
• The airway opens—usually accompanied
by a loud gasp—and air flows again.
• Then the cycle starts again.

Why be concerned about sleep apnea?
The combination of low oxygen levels and broken
sleep cause one or more of the symptoms
associated with sleep apnea:
1) Excessive daytime sleepiness
2) Snoring
3) Cardiovascular disease (“heart attack”)
4) Cerebrovascular disease (“stroke”)
5) Brain damage

In the May, 2009 issue of the Journal of the
American Dental Association, Simmons &
Clark, in an article entitled, The potentially
harmful medical consequences of untreated
sleep-disordered breathing, concluded:
“The evidence suggests that EH [Episodic
Hypoxia], as seen in SDB, causes damage
to the brain…and damage to higher
cognitive [thinking] functions.”

6) High blood pressure (hypertension)
7) Diabetes
8) Depression
9) Decreased sex drive and impotence
10) Morning headaches
11) Poor memory and clouded thinking
12) Personality changes and irritability
13) Restless sleep

14) Increased health care costs
15) GERD (Gastroesophageal Reflux Disease)
16) 10-15X more likely to have a motor
vehicle accident:
– 0 hours of sleep = .195% blood alcohol level reaction time
17) Loss of employment
18) Marital discord
19) Bruxism

Neurology of Sleep and Sleep-Related Breathing
Disorders and Their Relationships to Sleep
Bruxism, Simmons, JCDA; 2012 Feb;40(2):159-167
“Recent research by Simmons and Prehn
has demonstrated that SB or clenching may
occur as a mechanism to prevent airway
collapse. Their studies demonstrated that
during the SB process there is a reduction of
negative pressures of the upper
airway…When the SB process is not present,
there is an increase in airway obstruction.”

Effect of an Adjustable Mandibular Advancement
Appliance on Sleep Bruxism: A Crossover Sleep
Laboratory Study; Shönbeck, et al., Intl J
Prosthodontics, May-Jun 2009; 22(3):251-259
Results: The mean number of SB episodes/hr was reduced
by 39% and 47% from baseline with the MAA at a
protrusion of 25% and 75%, respectively.
Conclusion: Short-term use of an MAA is associated with a
significant reduction in SB motor activity without any
appliance breakage. A reinforced MAA design may be an
alternative for patients with concomitant tooth grinding and
snoring or apnea during sleep.

20) Increased mortality rate, especially for men.
Dr. Naresh Punjabi (John Hopkins) and nine other
researchers examined 6,441 men and women. (Sleep-
Disordered Breathing and Mortality: A Prospective Cohort
Study; PLoS Medicine, August, 2009).
Findings:
• Participants with severe SDB (an AHI of ≥ 30) were
about one and a half times as likely to die from any cause
after adjustment for potential confounding factors.
• In subgroups according to age and sex, men aged 40-70
years with severe SDB had twice the risk of dying as men
of a similar age without SDB.

21) CANCER!
Sleep disordered breathing and cancer
mortality: results from the Wisconsin Sleep
Cohort Study, Nieto, et al, AJRCCM, May 20,
2012:
“Compared to normal subjects, the adjusted
relative hazards of cancer mortality were
1.1 for mild SDB, 2.0 for moderate SDB,
and 4.8 for severe SDB.”

Measuring Sleep Apnea
AHI (Apnea-Hypopnea Index): The number
of apneas and hypopneas that occur per
hour.
Mild: ≥ 5 and < 15 events/hr
Moderate: ≥ 15 and ≤ 30 events/hr
Severe: > 30 events/hr

Pediatric OSA
• Frequently overlooked as a problem.
• Child often becomes overactive, rather than
sleepy. Some become hyperactive and are
diagnosed ADHD.
• Symptoms include: 1) Restless sleep; 2) Loud
snoring; 3) Nightmares; 4) Morning headaches;
5) Behavioral problems; 6) Bedwetting; 7) Gets
tired easily; 8) Wakes up tired; 9) Concentration
problems; 10) Is irritated.
• Most common causes: 1) Enlarged tonsils and
adenoids; 2) Narrow maxilla; 3) Obesity.

Grading Tonsils

When are Oral Appliances (OA’s) indicated?
In the AASM (American Academy of Sleep
Medicine) report in the February, 2006 issue
of SLEEP, Practice Parameters for the
Treatment of Snoring and Obstructive Sleep
Apnea with Oral Appliances: An Update for
2005, it states:

1) OAs are appropriate for use in patients
with primary snoring who do not respond
to or are not appropriate candidates for
treatment with behavioral measures such as
weight loss or sleep-position change.

2) Although not as efficacious as CPAP,
OAs are indicated for use in patients
with mild or moderate OSA who
prefer OAs to CPAP, or who do not
respond to CPAP, are not appropriate
candidates for CPAP, or who fail
treatment attempts with CPAP or
treatment with behavioral measures
such as weight loss or sleep-position
change.

3) Reviewed studies of patients with severe
OSA demonstrated treatment success
(variably defined) with OAs on an
average of 34.3% ± 13.5%...CPAP is
indicated whenever possible for patients
with severe OSA before considering OAs.

A December, 2011 study in Chest, “Efficacy of an
Adjustable Oral Appliance and Comparison with
CPAP for the treatment of OSAS, found…
“In comparison to past reports, more
patients in our study achieved an AHI < 5
using an aOA (adjustable oral appliance).
The aOA is comparable to CPAP for patients
with mild disease, whereas CPAP is superior
for patients with moderate to severe
disease.”

Journal of Clinical Medicine Special Article of
March, 2009: Clinical Guide for the Evaluation,
Management and Long-term Care of OSA in Adults
Some key points:
● Once the diagnosis is established, the patient should be included in deciding
an appropriate treatment strategy that may include PAP devices, OAs,
behavioral treatments, surgery, and/or adjunctive treatments.
● CPAP is the treatment of choice for mild, moderate, and severe OSA and
should be offered as an option to all patients. Alternative therapies may be
offered depending upon the severity of the OSA and the patient’s anatomy,
risk factors, and preferences and should be discussed in detail.
● If CPAP use is considered inadequate based on objective monitoring and
symptom evaluation, prompt and intensive efforts should be implemented to
improve PAP use or consider alternative therapies.

Appliance Therapy vs. nCPAP in
OSA; Respiration, Oct. 2010
The article looked at carefully controlled studies
in which both CPAP and OAs were carefully
titrated (adjusted).
Conclusion: There is no clinically relevant
difference between a MAD [Mandibular
Advancement Device] and nCPAP in the
treatment of mild/moderate OSA when both
treatment modalities are titrated
[adjusted] objectively.

How do you “titrate objectively”?
• After the patient is comfortable with the appliance,
additional advancement is slowly introduced.
• While this is occurring, subjective reports and tests (e.g.,
Epworth Sleepiness Scale) are used to assess progress.
• Once subjective relief of symptoms is achieved or the
limit of what the TMJs and/or musculature will allow is
reached, a sleep test is needed to quantify results.
• If indicated, we use the Medibyte portable home sleep
test monitor to quantify results before referring the
patient back to their primary care physician or sleep
physician for whatever sleep test they deem necessary.

MediByte®
(Home Sleep Test Portable Monitor)

MediByte® Highlights
● It is the smallest Type 3 recorder in the world at
3 x 2.8 x .75 inches. Weighs 3.3 ounces.
● It can record up to 12 channels and exceeds the
new AASM guidelines.
● On-board pulse oxyimetry, pressure and body
position sensors eliminate external transducers.

Other indications for an OA:
1) Use in travel or camping
2) In combination with CPAP:
a) Can advance mandible which allows patient to
reduce CPAP pressure—increasing compliance
b) No mask or headgear connected to nasal pillows
c) Mouth closed so no air will escape (ideal for
patients who tend to open mouth with CPAP)

What about Medicare?
• Custom oral appliances are covered under
Durable Medical Equipment, not Medicare Part B.
• Most dentists, if they accept Medicare at all, are
non-participating DMEPOS suppliers.
● Medicare, including supplemental insurance, will,
on average, reimburse $1321.60. However…

Medicare issued the following on July 5, 2012:
Custom fabricated mandibular advancement devices must meet all of
the criteria below:
1) Have a fixed mechanical hinge (defined as a mechanical joint
containing an inseparable pivot point).
2) Require no return dental visits beyond the initial 90-day fitting
and adjustment period to perform ongoing modification and
adjustments in order to maintain effectiveness…Items that
require adjustments beyond the initial 90-day period are not
eligible for classification as DME. These items are considered as
dental therapies, which are not eligible for reimbursement
by Medicare under the DME benefit. (Effective November 1,
2012?)

Medicare Limitations of Coverage
and/or Medical Necessity
The patient must have a Medicare-covered sleep test within the last
3 years that meets either of the following criteria (1 or 2):
1) The AHI or RDI is ≥ 15 (moderate or severe sleep apnea) or,
2) The AHI or RDI ≥ 5 and ≤ 14 (mild sleep apnea) with a
minimum of 10 events and documentation of:
– a) Excessive daytime sleepiness, impaired cognition, mood disorders,
or insomnia, or,
– b) Hypertension, ischemic heart disease, or history of stroke.

Types of Oral Appliances:
1) Mandibular advancement or repositioning
appliances (or splints or devices)
2) Tongue retaining devices

Medicare Comment Summary of Nov. 11, 2010:
Comment: There are no randomized, controlled
crossover trials that show efficacy of any prefabricated
[“boil & bite”] OA. As the literature only supports the
use of custom appliances, we urge the complete removal
of the paragraph giving preference to E0485
[prefabricated or “boil & bite” appliances].
Response: Agree. Because of the lack of proven
efficacy, prefabricated appliances will be denied as
not reasonable and necessary.

In an excellent study entitled Comparison of a Custom-
made and a Thermoplastic Oral Appliance for the
Treatment of Mild Sleep Apnea, Vanderveken, et al
concluded:
“In this study, a custom-made device turned out
to be more effective than a thermoplastic device
in the treatment of SDB. Our results suggest
that the thermoplastic [“boil & bite”] device
cannot be recommended as a therapeutic
option nor can it be used as a screening tool to
find good candidates for mandibular
advancement therapy.”

Custom Oral Appliances
SomnoDent G2 Flex

Adjustable PM Positioner (APM Ultra)

Elastic Mandibular Advancement (EMA)

SUAD Device

TAP 3

SomnoDent Herbst Appliance

Silent Nite

Full Breath Solution Lower

FBSL with a very small Tail

Mallampati 4 – Closed Airway

Lateral head x-ray without appliance. Note the distance between
the back of the throat and the soft palate (6.00 mm).© 2014 Bruce W. Roman, DDS, D. ABDSM

Notice the increased distance with the appliance inserted. (The white material
you see is the “tail” coated with barium).© 2014 Bruce W. Roman, DDS, D. ABDSM

Another lateral head x-ray before appliance insertion.

Same patient with appliance inserted. White squiggly lines are wires in the
appliance that help hold it in place.© 2014 Bruce W. Roman, DDS, D. ABDSM

The left image below is a three dimensional reconstruction
of a patient’s airway without a MAD. The right image is an
image with a MAD properly positioned in the mouth.

Tongue Retaining Devices
aveoTSD

[Original] Tongue Retaining Device

Evaluation for an Oral Appliance:
Sleep Test Review
The American Academy of Sleep Medicine Clinical
Guidelines states:
“The severity of OSA must be established in order to make
an appropriate treatment decision. No clinical model is
recommended to predict severity of obstructive sleep
apnea, therefore objective testing is required. A
diagnosis of OSA must be established by an acceptable
method (Standard). The two accepted methods of
objective testing are in-laboratory polysomnography (PSG)
and home testing with portable monitors (PM).”

• Chief Complaint addressed and OA
discussion and information
• Dental examination
• Periodontal examination
• TMJ examination

After suitability is established…
1) Diagnostic records: Study models,
panoramic or full-mouth x-rays,
cephalometric (head) x-ray (if indicated),
photographs.
2) Impressions for appliance fabrication and
a George Gauge bite registration.

George Gauge Bite Registration

Delivering the Oral Appliance
• Once the appliance is received from the dental
lab, it is tried in and adjusted.
• Directions for its use and care are given.
• A normal activation schedule is 1-2 turns every
3-4 days, while monitoring and adjusting that
schedule depending upon side effects.

How Long Does it Take?
• Usually results are noticed from the next morning to two
weeks. Snoring and excessive daytime sleepiness
decrease. Bed partners are very happy.
• Over the period of a few months, maximum/ideal
advancement is achieved. However, it can take up to 6
months for swelling in the throat tissues to be
eliminated. Home sleep tests may be used in the interim
or even as the final sleep test, depending upon the
desires of the sleep physician.

What is the Dental Team’s Role?
SCREENING--especially before:
● Placing a TMD orthotic.
● Removing teeth that would reduce
tongue space and/or “eliminate” the
possibility of surgery to advance the
mandible to open up the airway.

Aggravation of Respiratory Disturbances by the Use of an
Occlusal Splint in Apneic Patients: A Pilot Study (Gagnon,
et al., Int J Prosthodont 2004;17:447-453)
• Results: The AHI was increased by more than
50% in 5 of the 10 patients. The percentage of
sleeping time with snoring also increased by
40% with the splint.
• Conclusions: …study suggested that the use of
an occlusal splint is associated with the
aggravation of respiratory disturbances. It may
therefore be relevant for clinicians to question
patients about snoring and sleep apnea when
recommending an occlusal splint.

Screening 201
Have patient complete an Epworth Sleepiness
Scale*. If 9 or higher, refer to PCP.
Note: Males tend to significantly under report.
Much better to have the bed partner fill it out.
* The ESS was not designed for sleep apnea screening but is the most widely
used questionnaire. The Berlin Questionnaire (see web site) was designed
specifically as a screening tool, but is more complicated/timely to score.

Possible Complications and Side Effects of OA’s

Dental side effects of an oral device to treat
snoring & OSA, Sleep, March, 1999, Pantin, et al.:
• Excess salivation (30%)
• TMJ pain (27%)
• Dental discomfort (27%)
• Muscle discomfort (25%)
• Dry mouth (23%)
• Bite changes (12%)
• TMJ noises (7%)

“Five Years of Sleep Apnea Treatment with
a MAD”, January, 2010, Angle Orthodontist
Conclusions:
1) Five-year oral appliance treatment does not
affect TMD [“TMJ”] prevalence.
2) Is associated with permanent occlusal changes
in most sleep apnea patients during the first 2
years. However, this tendency reversed 2
years to 5 years.

Craniofacial Changes After 2 Years of
nCPAP Use in Patients with OSA
(Tsuda, et al.; Chest; Oct. 2010)
Results: 1) significant retrusion of the anterior maxilla;
2) setback of the supramentale and chin positions; 3)
retroclination of the maxillary incisors. (However, none
of the patients self-reported any permanent change of
occlusion or facial profile).
Bottom Line: There’s no free lunch with either nCPAP or
OAs. But treatment of OSA is far more important with
either modality than no treatment in comparison to
mostly minor or insignificant changes with both.

What about weight loss?
Effects of dietary weight loss on OSA: a meta-analysis, Anandam, et
al., Sleep Breath, February 29, 2012, concluded: Dietary weight loss
programs are effective in reducing the severity of OSA but not
adequate in relieving all respiratory events. Weight reduction
programs should be considered as adjunct rather than curative
therapy.
They also found:
• Patients with mild OSA who gain 10% of body weight are at a 6X
risk of progressing to a higher OSA severity.
• An increase of 10% over time increases the AHI, on average, by
30%.
• A 10-15% reduction in body weight can reduce the AHI by 50%.

Are there any exercises for patients with OSA?
Puhan, et al., in a December, 2005 article
in the British Medical Journal, Didgeridoo
playing as an alternative treatment for
OSA, showed that regular playing (6
days/wk, 25 mins/day for 4 months),
reduced the average AHI by almost 50%
(22.3 to 11.6) and lowered the ESS score
from 11.8 to 7.4

Note: If using for sleep apnea therapy, the headpiece is optional.

Clinical Asst Professor of Medicine, Univ of AZ, Rubin
Naiman, Ph. D., says: “Learning to play the didgeridoo is
emerging as a surprisingly effective and practical strategy
for managing snoring and sleep apnea patients.”

Oral Appliances for Snoring and Obstructive Sleep Apnea

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