Category 2: Mandibular Repositioners

Mandibular Repositioners (aka MAD’s, i.e. Mandibular Advancement Devices) are available in a variety of designs based on the needs and adaptability of the individual patient.  Appropriate planning and monitoring is important to assure success and avoid negative outcomes.  Numerous studies discuss the effectiveness of MAD’s in that they increase the airway diameter with soft tissue displacement by controlled and measurable mandibular protrusion.  The tongue is therefore affected either directly or indirectly by forward movement of the mandible which aids in preventing airway collapse. 

Studies show that MAD’s reduce the AHI (apnea-hypopnea index – the number of apnea and hypopnea events per hour of sleep.  Additionally, they improve the arousal index, oxygen saturation, increase REM sleep duration, and reduce snoring.   Most complications of MAD therapy are mild and temporary.  Changes in facial height and jaw relationship, dental changes, occlusal alterations to posterior teeth, and TMJ disorders may occur over time, thereby reinforcing the need for proper planning and monitoring.

THE CLEAR SLEEP™ APPLIANCE
The SML Clear Sleep™ Appliance reduces night time snoring and mild-to moderate Obstructive Sleep Apnea in adults by moving the mandible forward in 1mm adjustable increments and opening the airway for easier, unrestricted breathing. Customized to meet the needs of each individual patient, the SML Clear Sleep™ Appliance is comprised of two lightweight, low volume trays that are comfortable, retentive, and BPA-free. This appliance is particularly effective for patients who have a strong gag reflex and low tolerance for having anything in their mouth for any length of time. The Clear Sleep can be fabricated with or without a construction bite. A patient wearing this appliance will be able to open and close comfortably and move laterally with ease.

THE LAMBERG SLEEP-WELL™ APPLIANCE
The Lamberg Sleepwell  uses a series of patented Protrusive Element (PE) inserts to  hold the mandible and tongue in a comfortable forward position keeping the airway open while triggering a slight tightening of the soft tissues and muscles of the upper airway. ,. These inserts allow up to 9mm of AP advancement in .5mm increments. FDA-cleared for Snoring and OSA, this appliance is designed for patients who struggle with bruxism.  Its simple, non-threatening design and easy-to-clean, easy-to-adjust convenience yield high patient compliance. Although a construction bite is recommended to establish the ideal starting point for its fabrication, this appliance can be made without one as there is only a single point of contact in the anterior region.

THE ADJUSTABLE DORSAL™
Providing superior fit, retention and comfort, the SML Dorsal utilizes precision-milled upper and lower occlusal splints to open the vertical relationship while holding the mandible in the desired forward position. When wearing this appliance, the interlocking buccal inclines enable the patient to open and close normally while keeping the mandible from dropping open during sleep. Suitable for all dentitions, the SML hard acrylic Dorsal is ideal for patients who may need future restorative  One caution: This dorsal fin design limits the degree of mandibular lateral movement. So if your patient is a lateral bruxer, this is not the appliance of choice.

THE DORSAL ELITE™
Like all the Dorsal designs the SML® Dorsal Elite utilizes precision-milled upper and lower occlusal splints to open the vertical relationship while holding the mandible in the desired forward position. The Dorsal Elite utilizes a special metallic body screw perfectly inclined at 70-degrees and lower wings that are anatomically shaped to provide superior comfort and a perfect match with the upper screw bodies. The screw mechanism has built-in stops which ensure ideal friction and stability during forward movement. Activation is mistake free thanks to clearly visible laser marked arrows. Four adjustments produce 1mm of calibration.

THE ADJUSTABLE HERBST™ APPLIANCE  

This orthopedic appliance has been adapted to become one of the most commonly recommended and prescribed devices for the relief of snoring and obstructive sleep apnea. . It consists of two sturdy, acrylic full coverage orthotics joined by a Herbst screw on each side. The Herbst screws allow the lower orthotic and mandible to be advanced forward in an incremental fashion comfortably opening the airway. Patients who wear this appliance can open and close and move laterally with ease. The Herbst standard design is made with hard acrylic trays. Ball Clasps can be added for additional adjustable retention if needed.

THE ADJUSTABLE HERBST SLIMLINE™

The Adjustable Herbst Slimline™ is a light weight, pressure-molded appliance fabricated using 3mm dual laminate Erkodur® material that affords excellent patient comfort. It consists of a hard outer layer and a soft inner layer.  This design requires adequate natural posterior undercuts for optimum retention.  It is typically recommended to cap the incisal edges for added stability; however, if desired the incisal coverage can be removed.  If a specific amount of vertical opening is required and indicated by the provided Construction Bite, the occlusal surface of the upper tray is built up to cover only the molar and two bicuspids on either side.  Arrow markings on lower tray clearly indicate desired direction of adjustment.

THE ADJUSTABLE HERBST™ APPLIANCE FEATURING THE OASYS HINGE

Over the years, the Adjustable Herbst™ Appliance has become one of the most commonly recommended, most often prescribed devices for the relief of snoring and obstructive sleep apnea. The new OASYS Herbst Hinge Appliance is a FDA 510K Cleared Medical Device, and is approved by PDAC Medicare E0486. Here are some of the advantages of this new design:

1. The T-10 Hinge is a smaller profile hinge, which allows for more flexible placement, even in shorter arch cases.
2. It is also a telescope designed hinge that does not come a part with full extension.
3. It provides 10 mm of advancement, in comparison to the current 5mm hinge.
4. It is designed for intra-oral activation, in comparison of side activation out of the mouth.
5. The T-10 Hinge has etched mm marks on the hinge for identification of advancement, compared to the Scheu hinge which does not.
6. There is a Nylock coating in the hinge chamber to prevent backing off of the screw, plus a welded stop to prevent the screw from ever coming out of the chamber.
7. The Hex Wrench will activate the hinge screws for advancement and also is used for tightening or loosening the hex screws on the pivots.
8. The OASYS Hinge can also include the benefits of the OASYS Oral Nasal Airway System, with the available options of the Nasal Dilators and Lingual Tongue Lifters Nasal Dilators and Lingual Tongue Lifters.

OASYS ORAL/NASAL AIRWAY SYSTEM
The OASYS Oral / Nasal Airway System is cleared as a 510 K Medical Device by the ENT and Dental Divisions of the FDA. It is comprised of a fully adjustable Mandibular Repositioning appliance that easily adjusts forward and backward, 8-15mm on parallel bars, and a Nasal Dilator for improved breathing through the nose. The Nasal Dilators increase airflow through the nose with internal extensions in the maxillary vestibule that stretch the nasiolabial fold, and are easily adjusted intraorally. It also treats Sleep Disordered Breathing by addressing Upper Airway Resistance in the nasal region. It can be made with Lingual Tongue Buttons. This component adds tongue training and repositioning for improved tongue placement, better swallowing and improved sleep treatment results even in Severe OSA patients.

THE EMA® APPLIANCE
The EMA Oral Appliance works by opening the bite and gently advancing the mandible with interchangeable elastic straps to increase airway space. This custom made oral appliance is made from a proprietary thermoplastic polymer that delivers superior impact strength to acrylic at a lower cost than polycarbonate. EMA oral appliance increases airway space by advancing the mandible using interchangeable elastic straps. EMA elastic straps come in 9 different lengths and 4 different strengths. The shorter the EMA elastic strap, the farther the mandible is advanced. 36 different straps allow for effective repositioning with maximum comfort. ​With proper care, the EMA custom lab-fabricated appliance will effectively treat OSA for years.

THE TAP®
The TAP appliances come in a number of different designs and materials. The TAP 3 Elite has 3 hook sizes that allow for greater range of adjustment with minimal hardware. The TAP 3 has the smallest hardware for more tongue space. The TAP 1 (original TAP) has the greatest range of adjustment and an attached adjustment dial. The tray Liners can also be made of a number of different materials ranging from hard acrylic, a Triple Laminate material to ThermAcryl.

Regardless of the design you choose, the appliance will stabilize the mandible in the appropriate protrusive position, preventing airway collapse and tongue blockage. The unique design of the TAP appliances is that it allows the patients to fine-tune treatment at home. With a single point of central adjustment, the TAP prevents uneven bilateral adjustment that may create an irregular bite and jaw discomfort.

With the fixed mechanical hinge and inseparable pivot point, all TAP Custom devices meet Medicare requirements to treat OSA.

PANTHERA D-SAD™ (DIGITAL SLEEP APNEA DEVICE)
Thanks to our state-of-the-art CAD/CAM technology, you can now obtain a perfectly adapted Panthera D-SAD™ sleep appliance. This appliance is made from type 12 polyamide, a resistant biocompatible nylon. The unique titration mechanism of the Panthera D-SAD™ uses rods made of the same biocompatible polymer as the device. The length of the rods can vary from 16 to 36 mm and can be adjusted in 0.5-mm increments for a highly accurate and customized advancement. The rods are designed to resist bruxism and they will never elongate. Moreover, they will not disengage during sleep thanks to the unique way they connect to the device. We also offer rods specifically designed for heavy bruxism. In order to accommodate every patient, we offer a wide range of design modifications to improve comfort, retention and your choice occlusal contact, from our standard one to a customized anterior pad. Since the D-SAD™ can be adapted for every possible situation, it is suitable for all types of patients. Our procedures give you the tools you’ll need to predictability provide every patient with a completely customized device.

RIPPLE PLUS®
Ripple appliances are founded on the idea that bruxism affects the quality of sleep for millions of people and is widely misdiagnosed and untreated.  Clinical studies have shown the negative effect bruxism has on sleep, specifically the quality of sleep and length of REM. The automatic grinding of teeth and clenching of the jaw is characterized as bruxism which disrupts sleep. Ripple appliances provide full coverage, offering maximum retention, and uses the most advanced technology available, including milling, 3D printing, and digital scanning. The result is an effective, comfortable and accurate appliance that is custom manufactured to the individual’s ideal sleep position.

The Ripple plus is custom manufactured to the individual’s ideal sleep position for improved sleep. It allows for jaw support to maintain the airway and uses elastics that allow a proper range of motion and safe jaw position during clenching and grinding of the teeth.

The Ripple Plus effectively:

• helps maintain an open airway
• reduces bruxism
• reduces jaw and neck pain
• protects teeth
• increases energy and quality of sleep