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THE 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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For Dentists and Physicians

Clinical Videos

Dentist/Physician
Guidelines

Informed Consent Form

Long Term Consent Form

Klearway™Advancement
Schedule

Technical Notes for the
Klearway™ Appliance

For Patients

Video Demonstration

The Epworth Sleepiness
Scale

Patient Instructions for the
Klearway™ Appliance