| DENTIST
AND PHYSICIAN INSTRUCTIONS FOR THE KLEARWAY™ APPLIANCE
FOR THE TREATMENT OF SNORING AND OBSTRUCTIVE SLEEP APNEA
Insertion Appointment
Verify clasp locations on the Klearway™ appliance and
record the amount of opening of the screw with a ruler. 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 the patient's fingers
can tolerate. Instruct the patient to not heat the appliance
by any other means as they may irreversibly damage it. Insert
the appliance into the mouth and press the upper rim up onto
the upper back teeth. Have the patient close the lower teeth
forward into the lower portion of the appliance and bite firmly.
To remove the appliance, instruct the patient to push up on
the edges of the lower rim with both thumbnails. Once the
lower rim is off the teeth, instruct the patient to grasp
the edges of the upper back portion and pull down (not forward)
which will dislodge the appliance from the mouth. Instruct
the patient not to remove the appliance by simply opening
the mouth since the wirework may be permanently distorted.
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 screw. It is
not necessary to keep the appliance soaking in water during
the day. Advise the patient to use a denture cleanser tablet,
if required, to help remove stains and to keep the appliance
fresh. Do not soak the appliance in mouthwash, as it will
permanently soften the thermosensitive acrylic.
One-Week Follow Up
Record the amount of opening of the screw with a ruler.
Check for jaw muscle discomfort and any sore teeth. If the
patient experiences significant jaw discomfort, turn the screw
in the reverse direction to decrease the amount of mandibular
protrusion until the patient is comfortable. Relieve the acrylic
around any sore or uncomfortable teeth. Some patients may
experience a sense of the teeth not touching completely 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. 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.
One-Month Follow Up
Record the amount of opening of the screw with a ruler.
If the patient wears the appliance every night and is comfortable,
instruct the patient to activate the appliance two times per
week until the next appointment. Each turn or activation will
move the lower jaw gradually forward in 0.25mm increments
which has a direct effect on the three-dimensional size of
the airway. Insert the tip of the key into the hole on the
right side of the screw. Turn or push the key towards the
left. There is an arrow marked on the metal screw to show
the correct direction. Once the key is turned once from one
side to the other, remove the key. A new hole will appear
on the right side and will be used for the next turn later
in the week. If the key is removed before the new hole appears,
the patient will be unable to place the key in the new hole
the next time. Always remove the key after turning. Turning
the key back to the right side will close or retract the screw
rather than open or advance it. Verify that the appliance
has not been distorted or opened vertically. The anterior
shelves should be in contact to prevent any mandibular rotation
during sleep. A headgear plier may be used to vertically close
the posterior arms of the screw to ensure contact of the sliding
shelves. Record the amount of opening of the screw at each
appointment and record it in the patient’s chart. All
intraoral screws self close so the patients must also be instructed
how to measure and record the amount of opening on a regular
basis. A take home chart with the amount of advancement suggested
by the time of the next appointment is a useful patient aid
during titration.
Titration Appointment
If the patient reports a cessation of snoring and/or a resolution
of symptoms, further advancement of the mandible may not be
required. The screw must be tied off with stainless steel
ligature wire or filled in with cold cure acrylic to prevent
closure of the screw and retraction 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 Thereafter
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.
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For Dentists and Physicians