DENTIST INSTRUCTIONS – THE ZQUIET PRO-PLUS OVERVIEW The ZQUIET PRO-PLUS is an FDA-cleared, prescription-only intraoral appliance for the treatment of snoring and mild-to-moderate Obstructive Sleep Apnea (OSA) – and for patients who cannot tolerate CPAP. It is adjustable in .25mm increments (by patient or doctor). A total of six millimeters of anterior movement is possible.

The repositions the mandible to increase the patient’s pharyngeal space; increase airflow; reduce the vibrations of the soft palate associated with snoring; and/or prevent the collapse of the airway associated with apneic events. The device consists of two custom orthotics -- one for the maxillary arch and one for the mandibular arch -- made from acrylics widely used and approved for use in the dental industry.

The ZQUIET PRO-PLUS employs a buccal cam mechanism (an apposing fin and buttress) which maintains the orthotics in an anteriorized relationship when worn during sleep. The appliance provides for adjustable levels of jaw advancement to improve the comfort and effectiveness of treatment. Upon request, the maxillary orthotic can be made with an Omega Loop (which bisects the anterior midline) for patients who suffer from frequent headaches due to appliance use.

Fitting:When the patient has healthy dentition with adequate natural undercuts, Talon® is the preferred material for the retentive position of the appliance. A resilient, thermoplastic polymer that maintains its original flexibility for years, Talon® eliminates the need for any other form of mechanical retention. Its soft nature prevents the formation of pressure points and the patient adapts immediately. NOTE: Should the patient not have adequate natural undercuts in the posterior quadrants, it will be necessary to fabricate the base of the appliance with standard hard acrylic (using interproximal ball clasps for retention).

1. Seat the upper maxillary orthotic first, adjust for comfort.

2. Place lower mandibular appliance against the buttresses and have the patient advance their lower jaw and gently bite into lower device. Please note that the angle of the dorsal fin does not allow (in most cases) both individual orthotics to be seated prior to engagement.

3. Verify bilateral occlusal contact. Adjust for comfort and verify that appliance midline, vertical and protrusive measurements correspond to the lab slip.

LINGUAL RAMPSThe primary goal of oral appliance therapy is the facilitation of habitual forward and superior tongue posture, rather than excessive mandibular anterior repositioning. This more acceptable physiological treatment range helps to prevent TMJ problems.

Lingual ramps – small acrylic shelves attached to the mandibular lingual surface of the ZQUIET PRO-PLUS – provide support and stimulus for the anterior reflexive movement of the tongue, facilitating an upward and forward position – and preventing unnecessary (and excessive) anterior mandibular movement. These essential bilateral ramps support and encourage proper movement of the tongue – simply, efficiently, effectively.

OMEGA LOOPAppliances that cross the palatal midline restrict cranial-sacral movement. Cranial motion is a physiologic tenet of osteopathic medicine – and the Omega Loop allows for the expression of this very subtle motion. The ZQUIET PRO-PLUS is currently the only FDA-cleared mandibular repositioning appliance to incorporate the Omega Loop design element.

An optional component, The Omega Loop can prove extremely helpful for patients with a history of headaches – and for those who otherwise may be unable to tolerate the trans-palatal aspect of a removable device.

IMPORTANT: Patients treated with appliances that include the maxillary Omega Loop (particularly heavy bruxers) should be monitored for small midline diastema development.

Observation/Adjustment Visits: Schedule observation visits (as summarized below) to ensure that the appliance is comfortable and effective and that no dental problems have developed.

IMPORTANTThe expansion screw used on this appliance requiresten ¼ turns to achieve 1mm of expansion. Each ¼ turn (90o rotation) of the turnbuckle equals one-tenth of a millimeter.

Recommended maximum expansion: 5mm.

60% TO 70% PROTRUSIVE CONSTRUCTION BITE REQUIRED (as per standard OSA repositioning)

Week 1“Comfort Check.” Make any necessary adjustments for the fit and positioning. The appliance has two jack screws built in – one on each side. They must both be adjusted together for anterior movement. Each turn of the expansion screw from bar to bar advances the mandible approximately one-quarter millimeter (.25mm).

Month 1, 2, and 3 Evaluate teeth and appliance. Make any necessary adjustments.

6 months Check progress with the appliance and address any patient concerns. Yearly Inspect teeth and the appliance. This allows you to minimize any side effects and make any necessary appliance repairs.

SML®

SPACE MAINTAINERS LABORATORIES9129 Lurline Avenue

Chatsworth, CA 91311Phone: 818-998-7460 or 800-423-3270

Fax: 818-341-4684

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A complete and proper diagnosis must precede treatment. OSA is a medical condition and can only be diagnosed by a physician. Following a diagnosis, explain ALL options available to the patient and have them sign an Informed Consent document which can be downloaded from www.SMLglobal.com IMPORTANT: The patient should have eight healthy teeth in each arch (no loose or broken teeth and no temporary fillings or temporary crowns). Never treat a patient who has acute TMJ pain. Resolve the acute TMJ pain issues first. Then treat the sleep issue (often a perpetuating factor in joint pain).

The dentist will evaluate how the patient is doing and make necessary adjustments to the device at scheduled follow-up visits -- until subjective reporting indicates an effective response to the device. When subjective reporting is positive, the patient must be evaluated -- with an attended PSG or a home sleep test device -- to objectively validate the efficacy of the treatment position.

Upon obtaining satisfactory objective data, the patient is referred back to his/her physician for evaluation. This, again, is because OSA is a medical condition. Only a physician can make a diagnosis or evaluate treatment efficacy.

IT IS ESSENTIAL THAT THE PATIENT BE TESTED WITH A HOME SLEEP TESTING DEVICE OR AN OVERNIGHT-ATTENDED PSG TO VALIDATE (WITH OBJECTIVE DATA) TREATMENT POSITION EFFICACY.

ALWAYS follow-up with your patient’s sleep physician (and any other treating physicians. ) with regard to status of your mutual patient.

OFFICE PROTOCOL Oral Health and Medical Health History Assessment:The dentist must perform a complete oral health assessment as well as a medical health history assessment including;

• Full medical and dental health history• Dental radiographs• Clinical oral evaluation • General patient interview

NOTE: Dentists should evaluate the medical health history of the patient – including history of asthma, breathing or respiratory disorders, other relevant health problems -- and refer the patient to the appropriate healthcare provider before prescribing the device.

Impressions: Dental impressions of the upper arch of teeth and palate and the lower teeth should be taken -- using a high quality alginate such as Kromopan or PVS impression material. Take full extension impressions into the maxillary vestibule and mandibular sublingual area. The extension should extend to the height of the gingival contour on all sides of the teeth. The models should then be poured and carefully evaluated for defects. Accepted models can then be trimmed and dried in preparation for packing and shipping. Bite Records: Bite registration is an important step when constructing any dental appliance, particularly sleep appliances. In order for the laboratory to construct an appliance that positions the jaws in the proper relationship to one another, it is necessary to record this relationship (in the patient’s mouth) with a hard wax or elastomeric material. When the vertical is customized (see order specifications below) some suitable material should be added to the inter-incisal aspect of the gauge to reflect the correct opening measurement.

BITE REGISTRATION: 50% - 70% MAXIMUM PROTRUSION (DEPENDING UPON PATIENT RANGE OF MOTION).

The following steps are recommended: Using an Andra or George Gauge, measure the range of motion of the mandible along its anterior-posterior travel. Both gauges are available from SML™ (1-800-423-3270), www.SMLglobal.com.

Set the gauge at a fixed position, approximately 70% protruded from the most retruded position. NOTE: The 70% protruded position is a widely accepted starting point for therapy. If patient has a narrow arch form or a large tongue, lingual ramps should be specified when ordering. Patient comfort and appliance efficacy will guide you in adjusting the protrusiveness to the optimal treatment position at subsequent visits. After setting the gauge, insert it in the mouth and have the patient practice closing into the notches on the bite forks. Then remove the gauge from the mouth and place softened wax or elastomeric material on both sides of the bite fork component. Have the patient bite down into that material until it sets or hardens. IMPORTANT: Make sure that the skeletal midlines are aligned when at the protruded position. Make sure that the models fit into the bite record without rocking. The bite record should then be wrapped in bubble wrap and included with models sent to the lab.

Ordering Specifications: Vertical OpeningThe vertical opening ensures enough room for the tongue. The larger the tongue, the more vertical necessary. Every patient is different, but the tongue size and primary position (during sleep) should be noted. The following is a suggested guideline that can be used to specify the vertical opening:

FEMALE PATIENT -- sleeps primarily on her side and has no scalloping of the tongue. Vertical Dimension increase: 5.5mm.

FEMALE PATIENT -- sleeps primarily on her back and/or has a scalloped

tongue. Vertical Dimension increase: 6.5mm.

MALE PATIENT -- exhibits normal tongue and sleeps predominately on his side. Vertical Dimension increase: 6.5mm.

MALE PATIENT -- scalloped tongue and/or sleeps predominately on his back. Vertical Dimension increase: 8.0mm

NOTE: Humans are obligate nasal breathers. Take great care to ensure that the patient can maintain unstrained lip seal. Poor lip seal can lead to mouth breathing and subsequent uncomfortable drying of the oral mucosa.

Shipping the Case:Models and bite records should be wrapped with bubble wrap and shipped to our certified laboratory in a box -- along with a prescription for the Z-QUIET PRO-PLUS.

Disinfection (prior to dispensing appliance): Prior to patient contact, the new ZQUIET PRO-PLUS should be properly washed and disinfected. Spray disinfectant of choice directly on the pre-cleaned appliance, thoroughly wetting all sides. Allow the surface to remain visibly wet for 3 minutes at room temperature. A thorough rinse with high quality potable water is then required. All warnings and precautions should be strictly observed.

IMPORTANT: FOR OPTIMUM CONTINUOUS-CARE CONVENIENCE, we recommend that your patients consider the OAP Appliance Cleaner – the best way to keep your ZQUIET PRO-PLUS sparkling clean and odor free. With a touch single pump the OAP Appliance Cleaner eliminates 99.99% of bacteria in just 1 minute.

Delivery (to the patient):The delivery visit should confirm the fit and comfort of the appliance -- as well as the patients’ ability to insert and remove it properly and without difficulty.