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KLEARWAY™ APPLIANCE FOR THE TREATMENT OF SNORING AND OBSTRUCTIVE
SLEEP APNEA Alan A. Lowe, DMD, PhD, FRCD(C), FACD
Professor and Chair, Division of Orthodontics, Faculty of
Dentistry
The University of British Columbia, 2199 Wesbrook Mall, Vancouver,
BC, V6T 1Z3, Canada
A. Diagnosis
and Interaction with Sleep Physicians
B. Features of the Klearway™
Appliances
C. Available Research on the
Klearway™ Appliance
D. Suggested Klearway™ Appointment
Sequence
E. Insurance Coverage
F. Overview
A. Diagnosis and Interaction
with Sleep Physicians
Over the past few years, many dentists are increasingly being
asked about the use of oral appliances for the treatment of
snoring and Obstructive Sleep Apnea (OSA). Approximately 50
million people annually report some type of sleep problem
to their physician. Oral appliances for the treatment of snoring
and OSA fall into two main categories - those which hold the
tongue forward and those which reposition the mandible (and
the attached tongue) forward during sleep. Any dentist with
an interest and a minimal amount of training in the field
who has established a working relationship with a local sleep
center can begin to provide effective therapy for a large
group of patients with snoring and OSA. Prior to the treatment
of either snoring or OSA with any oral appliance, a complete
assessment by the patient's physician and/or sleep disorder
specialist is very important. The physician may or may not
require an overnight polysomnogram to diagnose the sleep disorder
and usually provides the dentist with a written referral or
prescription and a copy of the diagnostic report. Because
of the obvious life threatening implications of a number of
sleep disorders, it is imperative that Klearway™ therapy
commences only after a complete medical assessment. The American
Sleep Disorders Association recommends that oral appliances
be used in patients with primary snoring or mild OSA and in
patients with moderate to severe OSA who are intolerant of
or refuse treatment with nasal Continuous Positive Airway
Pressure (nCPAP). For some patients, combination therapy with
other treatments such as weight loss, surgery and nCPAP may
be indicated and this must be coordinated by the attending
sleep physician. An international group of dentists with particular
expertise in this area called the Sleep Disorders Dental Society
provides a newsletter, an annual meeting, a slide/manual guide
and a library for member dentists and a Resource Center for
both patients and dentists (Tel 412-935-0836).
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B. Features of the
Klearway™ Appliance
Klearway™ offers several distinct advantages over other
appliances currently available on the market. It works by
keeping the teeth together and holding the lower jaw and tongue
forward during sleep to open the airway. Klearway™ possesses
excellent retention characteristics designed to keep the appliance
in the mouth during all the various complex jaw movements
which can occur during sleep. Klearway™ provides full
occlusal coverage of both arches and is very carefully designed
not to encroach on tongue space. Furthermore, it facilitates
the very slow and gradual movement of the mandible by permitting
the patient to adjust the appliance according to his or her
own comfort level with the guidance of the attending dentist.
This fully-adjustable oral appliance is much more comfortable
to wear than a single jaw position appliance which often may
require time-consuming and expensive remakes to place the
mandible in the ideal forward position required to adequately
open the airway. Fabricated of thermoactive acrylic, Klearway™
becomes pliable for easy insertion and confirms securely to
the dentition for an excellent fit while significantly decreasing
soft tissue and tooth discomfort. A total of 44 forward positions
are available in increments of 0.25 mm which covers a full
11.0 mm range of A/P movement. Such small increments help
avoid rapid forward jaw movements that can cause significant
patient discomfort. Klearway™ allows the patient to
feel less restricted and thus less claustrophobic - a sensation
experienced by a small number of patients during the first
few nights of wear. Once warmed under hot water and inserted,
the acrylic resin hardens as it cools to body temperature
and firmly affixes itself to both arches. Lateral and vertical
jaw movement is permitted which enables the patent to yawn,
swallow, and drink water without dislodging the appliance.
Patients with bruxism are also very comfortable in this appliance
since it does not prevent jaw movements during sleep. In 1995,
the Klearway™ appliance was invented at, trademarked
for, and applied to the FDA for market approval by, The University
of British Columbia. Patents have been obtained by the university
both in North America and internationally and specific licensees
have been assigned the rights to manufacture the appliance
worldwide.
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C. Available Research
on the Klearway™ Appliance
The Klearway™ appliance is the most extensively researched
oral appliance available due in part to an extensive multi-centre
four year clinical trial funded by the Canadian government
through the National Centres of Excellence Program (Inspiraplex)
which has compared the effectiveness and covert compliance
of Klearway™ with nCPAP. In a preliminary comparison
of 38 patients from three sites, the severity of the OSA (as
measured from polysomnogram Respiratory Disturbance Indices
before and after Klearway™ insertion) was reduced to
a clinically acceptable level in 80% of a group of moderate
OSA patients and in 61% of a group of severe OSA patients.
Fiberoptic videoendoscopy documented that the airway size
was significantly increased at the level of the velopharynx.
Covert compliance data measured with a newly developed miniaturized
temperature sensitive monitor imbedded in the appliance indicated
that it was worn for a mean of 6.8 hours per night. In conclusion,
the Klearway™ adjustable mandibular advancement appliance,
made from thermoelastic acrylic resin, has a direct effect
on airway size, is consistently well worn throughout the night
and significantly improves the sleep quality of OSA patients.
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D. Suggested Klearway™
Appointment Sequence
Although each clinician will develop his or her own sequence
of Klearway™ appliance therapy, the completion of a
number of specific procedures ensures that the appliance is
effectively designed and monitored over the long term by both
the dentist and the attending sleep physician.
Initial Examination and Record Taking
After referral from the patient's sleep physician, the dentist
is encouraged to follow the protocol developed by the Academy
of Sleep Dentistry. An oral assessment is essential to ensure
that the patient has a healthy mouth and sound teeth in each
arch and that unrestricted forward jaw movement is possible.
Patients with mild TMJ discomfort and/or bruxism can usually
wear Klearway™ with ease since the jaw position used
is very comfortable for both the TMJ and the dentition over
the long term. Totally edentulous patients may not be ideally
suited for treatment with mandibular repositioners since they
may not have enough intraoral retention to keep the appliance
in the mouth during sleep. Patients with edentulous maxillary
arches and adequate teeth in the lower arch may respond favourably
to Klearway™ therapy. A stone model of both arches from
impressions is submitted to the laboratory together with a
bite registration taken at two-thirds the distance from centric
occlusion to full protrusion. For the best accuracy, a George
gauge with a grey 2.0 mm fork should be used for the bite
registration. Four teeth (first bicuspids and molars unless
otherwise requested) are selected for the placement of ball
and/or Adam's clasps in the event that added retention may
be needed later in treatment. For a limited number of patients
with atypical jaw movements, optional soldered balls can be
placed at the ends of the distal expansion screw arms to ensure
that the upper and lower arches remain connected .
Insertion Appointment
After showing the patient their custom-made appliance, describe
all the possible limitations and side effects of this form
of therapy. In addition, have the patient read and sign an
Informed Consent Form and answer any questions before inserting
the Klearway™ appliance. Verify the clasp locations
and record the amount of opening of the expansion screw with
a Boley gauge. Instruct the patient to insert the appliance
by first submerging it in a container of hot tap water, or
to hold the appliance under running hot water only as hot
as their fingers can comfortably tolerate. Instruct the patient
not to heat the appliance by any other means as they may irreversibly
damage it. While observing their teeth and the appliance in
a mirror, have the patient insert the appliance into the mouth
and press the upper rim up onto the upper back teeth. Once
fully seated on the upper teeth, have the patient close the
lower teeth forward into the lower portion of the appliance
and bite firmly. When the appliance is fully seated, the patient
is able to confirm visually that each tooth is in the correct
position in the appliance. To remove the appliance, rinse
the mouth with warm water. Instruct the patient to grasp the
edges of the upper back portion and pull down (not forward)
which will dislodge the appliance from the upper jaw. Then
ask the patient to push up on the edges of the lower rim with
both thumbs while opening at the same time to dislodge the
appliance from the mouth. Instruct the patient not to remove
the appliance by simply opening the mouth since the wire work
may be permanently distorted and the appliance subsequently
ruined. To clean the appliance, advise the patient to use
a stiff toothbrush and any toothpaste and to thoroughly brush
inside the tooth portion of the appliance as well as the smooth
outside surface and to use the same brush to clean the expansion
screw. Because this appliance is made from thermoacrylic material,
it is not necessary to keep the appliance soaking in water
or mouthwash during the day. Advise the patient to use a denture
cleanser tablet like Oral Safe™, if required, to help
remove stains and to keep the appliance fresh.
One Week Follow Up
Record the amount of opening of the expansion screw with
a Boley gauge or a mm ruler. Check for jaw muscle discomfort
and any sore teeth. If the patient experiences significant
jaw discomfort, turn the screw in the reverse direction of
the arrow to decrease the amount of mandibular protrusion
until the patient is comfortable. The appliance is designed
in the laboratory to allow for this setback from the initial
two-thirds forward position if same is required after the
initial insertion. Relieve the acrylic around any sore or
uncomfortable teeth. A sense of the teeth not touching completely
may be experienced by some patients in the morning. This usually
disappears within an hour or so. In addition, they may experience
an excessive amount of saliva for the first month or so.
One Month Follow Up
Record the amount of opening of the expansion screw with
a Boley gauge or a mm ruler. If the patient wears the appliance
every night and is comfortable, instruct the patient to activate
the appliance by turning the screw on the top of the appliance
two times per week until the next appointment. Each turn or
activation in the direction of the arrow will move the lower
jaw gradually forward in 0.25 mm increments which has a direct
effect on the three-dimensional size of the airway. The Klearway™
appliance has been shown to be particularly effective in increasing
the size of the velopharynx. Have the patient insert the tip
of the key into the hole on the side of the expansion screw
at the base of the arrow. Turn or push the key towards the
direction of the arrow imprinted in the metal expansion screw
which shows the correct movement to advance the lower jaw.
Once the key is completely turned from one side to the other,
remove it and a new hole will appear for the next turn. If
the key is removed before a new hole appears after the completed
turn, the patient may be unable to fully place the key in
the new hole. Always remove the key after turning. Turning
the key opposite to the direction of the arrow will close
the expansion screw and retract the mandible. If significant
jaw or joint discomfort occurs, advise the patient to stop
turning the screw until their next visit. If the discomfort
has not subsided in one or two days, have the patient call
the office immediately. Verify that the appliance has not
been distorted or opened vertically. The anterior shelves
should be in contact to prevent any downward mandibular rotation
during sleep. Any plier may be used to vertically close the
arms of the expansion screw to ensure contact of the anterior
sliding shelves. While holding the expansion screw of the
softened and downward orientated Klearway™ from behind
with the plier, push down on the acrylic portion of the maxillary
arch to close the vertical dimension.
Titration Appointment
Some patients stop snoring and feel more rested shortly
after Klearway™ is inserted and no further advancement
of the mandible is required. Others may require two or three
months of slow and gradual forward repositioning before a
significant treatment effect is noted. When the patient and/or
bed partner reports a cessation of snoring and a resolution
of symptoms, further advancement of the mandible may not be
required. The expansion screw should be tied off with stainless
steel ligature wire or filled in with cold cure acrylic to
prevent any further movement of the mandible. The patient
should be referred back to their physician and/or sleep specialist
for assessment at this time.
Every Six Month Follow Up
If the oral appliance has been shown to be effective and
the patient is comfortable, every six month recall appointments
should be scheduled. At each appointment, check the status
of the occlusion and verify that the appliance has not been
distorted. Minor cracks in the appliance can be repaired at
the chair side with cold cure acrylic. Expansion screws may
self close over time and therefore should always be permanently
stabilized for long term Klearway™ wear. The overall
management of the patient's particular sleep disorder remains
the responsibility of their attending physician.
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E. Insurance Coverage
The Academy of Dental Sleep Medicine recommends that when
filing for third party reimbursement, the claims should always
be sent to the medical insurer and include a copy of the physician's
referral letter, a copy of the initial diagnostic sleep study
and a personal letter of explanation about oral appliance
therapy. Members of the Academy of Dental Sleep Medicine have
access to updated insurance information directly from the
Resource Center.
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F. Overview
Becoming involved with the treatment of snoring and OSA
can be a very exciting and rewarding part of any dental practice.
To effectively change the quality of someone's life with an
oral appliance can significantly alter a practitioner's perspective
on health care delivery. The Klearway™ appliance is
the most extensively researched appliance available today
and it has been shown to effectively increase airway size,
to be worn consistently and to have a significant effect on
both snoring and OSA. A built in compliance monitor is expected
to be commercially available within one year's time which
will permit covert monitoring of appliance wear.
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