The Klearway®

Oral ApplianceToday’s most thoroughly researched oral appliance for the treatment of snoring and mild obstructive sleep apnea (OSA)

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A clinically proven oral appliance with the following special features: ■ Extensively researched and tested■ Multiposition, patient adjustable advancement■ Comfortable and well-tolerated by patients■ Excellent retention■ Developed by a recognized academic

in the field of OSA

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OSA is a disorder of the upper respiratory tract in which the tongue is sucked back against theposterior wall of the pharynx by the negative pres-sure of inhalation. If the obstruction remains inplace for more than 10 seconds, and occurs morethan five times per hour, the patient will usuallysuffer the symptoms of sleep deprivation the fol-lowing day. This is known as obstructive sleepapnea (OSA). In severe cases this condition canbe life-threatening.

Snoring occurs when the tongue is posteriorly dis-placed, but does not contact the posterior pharyn-geal wall. This narrows the airway and causes airto move more rapidly through the passages, caus-ing the vibrations of snoring. All OSA patients aresnorers, but not all snorers have OSA. BecauseOSA can be a serious disorder, all snorers shouldbe screened for the condition. It is alsorecommended that patients not be treat-ed without a referral from a medicaldoctor who is competent in thefield of sleep disorders.

Oral appliances have been foundto be effective in treating snor-ing and mild OSA, and in mod-erate to severe OSA patientswhen CPAP or uvula surgery have proven unsuccessful. ■

Indications for use of theKlearway® oral appliance:

Klearway®

is the most

thoroughly

researched oral

appliance for

the treatment

of snoring

and OSA.

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Klearway® is the clear choice

Klearway is the most thoroughly researched oralappliance for the treatment of snoring and OSA.This extensive research effort, funded by theCanadian government, includes clinical trials andcrossover studies comparing the effectiveness andcovert compliance of Klearway with other oralappliances and CPAP.

Proven superior to other oral appliances for thetreatment of snoring and OSA, Klearway’s comfort-able, thermal sensitive material enables a better fit,and therefore, better retention.

The advantages of theKlearway® appliance:■ Facilitates slow and gradual movement of jaw

position by permitting the patient to adjust the appliance according to his or her own comfort level with the guidance of the attending dentist.

■ Can be adjusted to over 44 positions, in increments of 0.25mm.

■ Fabricated of thermoactive acrylic, which significantly decreases soft tissue and toothdiscomfort.

■ Permits lateral and vertical jaw movement, enabling patients to yawn, swallow and drink water without dislodging the appliance.

■ Provides full occlusal coverage of both arches.■ Does not encroach on tongue space.

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The

Klearway’s®

engaged arches

provide full

occlusal

coverage and

allow freedom

of lateral

movement.

Clinical Use:Prior to treatment with an oral appliance, thepatient must be assessed by the attending physicianand/or a sleep disorder specialist. In most cases,the physician may require an overnight polysomno-gram to diagnose the sleep disorder and to providethe dentist with a written referral or prescriptionand diagnostic report.

The dental examination should include the follow-ing: a medical/dental history; soft tissue/intraoralassessment; periodontal evaluation; temporoman-dibular joint (TMJ)/occlusal examination; intraoralhabit assessment; examination of teeth and restora-tions; dental radiographs no older than six months(panoramic or full mouth survey, cephalometricradiograph); and diagnostic models. The ApneaLink or the Epworth Sleepiness Scale may also beused as a screening tool at the initial exam andduring duration of the oral appliance therapy. ■

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Records – The technician at Great LakesOrthodontics will require a stone model of both arches from impressions. Make sure theimpressions extend into the vestibules for utmostretention. In addition to the models, we alsorequire a bite registration, two-thirds the distancefrom centric occlusion to full protrusion, with a5mm incisal vertical opening. A George gaugeshould be utilized with the White 5mm fork forutmost accuracy.

The clasping is standard, however, the dentist mayindicate where he or she would like the clasps. Anaccurate bite registration is critical in fabricatingan appliance which will not impair the teeth, softtissues, or TMJ/occlusion. Since added retentionfor the Klearway appliance may depend on fourBall clasps, the patient should have at least oneclinically sound tooth in each quadrant.

1

Three steps toa good night’s sleep for

your snoring/osa patients

Klearway’s®

unique design

helps to

prevent tongue

encroachment.

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2Insertion and activation – When the applianceis returned from Great Lakes, first verify the loca-tion of the clasps on the appliance, and recordthe opening of the expansion screw with a Boleygauge. Have the patient prepare the appliance for insertion by holding it under running hot tapwater. The water should be no warmer than canbe tolerated by the patient’s fingers, and the appli-ance should not be heated in any other manner.

The Klearway is then inserted into the mouth,pressing the upper rim onto the upper back teethfirst. Once seated on the upper teeth, the patientshould close the lower teeth forward into the lower portion of the appliance and bite firmly. Tosecure the appliance, have the patient use fingersto press along the buccal segments and use thetongue to address the lingual area.

To remove the appliance, the patient should rinsewith warm tap water, prior to removal. This willenable the patient to remove the appliance while itis soft and pliable. (Tip: Some patients find it easierto remove the appliance during their morningshower when they can expose the acrylic longer towarm water.) When you are sure the patient caninsert and remove the appliance easily, and he orshe is comfortable with the appliance inserted,schedule a follow-up appointment in one-week’stime. After the patient has demonstrated regularconsistent wear, the appliance is activated orturned twice per week on average by inserting the

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3

tip of the key into the hole on the right side of theexpansion screw. Turn or push the key towardsthe left. There is an arrow marked on the metalexpansion screw to show the correct direction.Always have the patient remove the key after turn-ing. A new hole will appear on the right side of the appliance to be used for the next turn later in the week.

The patient can be instructed to turn the expan-sion screw one increment at a time twice a weekas long as the appliance remains comfortable.Turning the key back to the right side will close or retract the expansion screw, if this is desired.Each turn or activation will gradually move the jawforward, thus increasing the three-dimensional sizeof the airway and improving the patient’s ability tobreathe comfortably.

Follow-up – For the first week follow-up, mea-sure the amount of opening of the expansion screwwith a Boley gauge. Check the patient for jaw mus-cle discomfort and any sore teeth or soft tissuespots. If the patient is experiencing significant jawdiscomfort, turn the screw in the reverse directionof the arrow to decrease the amount of mandibularprotrusion until the patient is comfortable. Relievethe acrylic around any sore spots or uncomfortableteeth. The patient can be scheduled for follow-upin a month.

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One-month follow-up – Again, measure andrecord the opening of the expansion screw with aBoley gauge. If the patient remains comfortable,have him or her continue to activate the appliancetwo times per week until the next appointment.

Verify that the appliance has not been distorted oropened vertically by making sure the anteri-or shelves are in contact. This is neces-sary to prevent mandibular rotationduring sleep. A headgear pliercan be used to vertically closethe posterior arms of theexpansion screw to ensurecontact of the sliding shelves.

Titration appointment –When the patient reports a ces-sation of snoring and/or resolu-tion of the symptoms, it may beunnecessary to move the mandiblefurther forward. The expansion screwcan be tied off with stainless steel ligaturewire or filled in with cold cure acrylic to pre-vent any further movement of the mandible. At this time the patient should be referred back to his or her physician and/or sleep specialist for areevaluation.

Six-month follow-up – As long as the appliancehas shown to be effective and the patient is com-fortable, six-month recall appointments will be suf-ficient to check the occlusion and verify that theappliance has not been distorted. ■

Klearway’s

comfortable,

thermal sensitive

material enables

a better fit,

and therefore,

better

retention.

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The developer of theKlearway® appliance

Alan A. Lowe, DMD, PhD., FRDC(C), is Professor and Head of the Department of ClinicalSciences at the University of British Columbia inVancouver, British Columbia, Canada. Dr. Lowehas been involved in the research of oral appli-ances for use in treating snoring and OSA disor-ders since 1987. He is known in his field as theprominent investigator who compares the use-fulness of oral appliances and other treatmentmodalities. Dr. Lowe has given a number of lec-tures and has authored and coauthored severalarticles on the use of oral appliances for the treatment of sleep disorders. ■

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The patient should not remove the appliance by simplyopening his or her mouth. This can permanently dis-tort the wire work and render the appliance useless.Some patients will experience a sense of the teeth nottouching in the morning. This will disappear within anhour or so. For the first month or more, some willhave an excessive amount of saliva, a symptom whichwill also go away on its own. If the patient experiencessignificant jaw or joint discomfort, have him or her stopturning the screw until the next visit. Ask that thepatient call the office if the discomfort doesn’t subsidewithin one or two days.

To clean the appliance, the patient can use a stiff tooth-brush and any toothpaste. The appliance should bethoroughly brushed, inside and outside, as well as theexpansion screw. Because this product is made fromthermoacrylic material, it does not have to be kept inmouthwash or water when it is not in the mouth. Werecommend DentaSOAKTM for your patients. Gentle,effective, and easy to use, DentaSOAK cleans anddestroys infection-causing bacteria - in just 15 minutes.DentaSOAK is non-toxic, alcohol free, and persulfatefree. DentaSOAK is available in a three month, sixmonth, or one year supply. FREE patient brochures areavailable. To order DentaSOAK, call Great LakesProducts Customer Service toll-free at 800-828-7626,direct at 716-871-1161, or fax your order to716-871-0550. Your DentaSOAK order will arrive in about 10 days. ■

Cautions and care

Patent No. 5,409,017 University of British Columbia

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200 Cooper AvenuePO Box 5111

Tonawanda, NY 14151-5111

Toll Free: 1-800-828-7626Local: 716-871-1161 Fax: 716-871-0550

© 1995 Great Lakes Orthodontics, Ltd.

SMLP210Rev092208S-160

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