Australasian Dentist Magazine Sept-Oct 2021

Category 70 Australasian Dentist clinical breakage, permanent stretching or plastic deformations, the EVOmaterial flexed and returned to its pre-test shape. Surprisingly, EVO defeated the third-party laboratory destructive testing. EVO features a true anatomical, low profile, comfortable design made possible by MG6 technologies. Overall, EVO is 2.5 times smaller than the average legacy OAT device. EVO also has an optimized, low profile design: 5.0 times lower profile in the lingual areas, 1.5 times lower profile in the facial areas, and 1.3 times lower profile in the titration mechanism areas. The EVO splint component is uniquely designed based on a mirroring of the actual dental anatomy for each patient to create a familiar, comfortable mouth feel. In the IRB study, 100% of patients (21/21) preferred EVO to their CPAPs. 100% (20/20) stated that they would wear EVOmore than their CPAPs. 100% (21/21) said EVO would be significantly easier to keep clean than their CPAPs. 93% (26/28) of patients in the IRB study strongly preferred EVO to their legacy OAT devices. 97% (27/28) said it was easy to close their lips together with EVO. 93% (26/28) strongly agreed that EVO was smaller than their previous OAT device. 97% (29/30) strongly agreed that EVO’s anatomical contours had a more natural, smooth feeling. Biocompatibility and Stain Resistance Open up an EVO container. How does it smell? When opening a container for a legacy OAT device it usual smells of residual monomers. Even the newer CAD/CAM hybrid devices still smell like chemicals. Not EVO. EVO material is classified by the United States Pharmacopeia and National Formulary as Class VI. Class VI is the highest grade of material currently available. To achieve Class VI designation, a material must pass a battery of oral, subdermal, and intramuscular toxicity tests. The material for EVO was selected be- cause it satisfied the clinical performance requirements of leading DSM provid- ers while also being Class VI. The main downside of this material is that it is more expensive. Until recently, ProSomnus did not have the buying power to purchase this material at a reasonable price. EVO material is highly resistant to staining. Unlike the lower performance materials used in soft liners, acrylic, and nylon devices, EVO material has better modulus without being as porous. To test stain resistance, an EVO device, a CPAP mask, and a selection of OAT devices were subjected to a 10-day mustard bath test (Fig. 5). A colorimetry score (Delta E) was captured before and after the mustard bath and compared. EVO exhibited virtually no change in color and was on par with the ProSomnus [IA] test device. The CPAP mask was next best, outperforming the traditional acrylic, thermoform, lined CAD/CAM, and nylon material devices. Precision OAT Evolved All manufacturing processes have errors. Think about playing golf or taking an impression. Why is one’s golf swing not perfectly the same every time? Why are impressions not perfect every time? It is because variability error exists in the processes, the materials, the environmental factors, and more. These types of variance errors also exist when transferring a DSM provider’s bite into the design of an OAT device. Some legacy OAT manufacturing processes have over 50 steps – 50 opportunities for variability! An investigation of bite transfer precision found that the average legacy OAT device has 3.7mm, ranging from 1.2mm to 6.0mm, of global variance between the bite provided and the setup of the device (Hu, 2020). This is significant when considering that themean protrusive range of the mandible is 8.0mm. ProSomnus devices reproduce the bite accuracy within 0.32mm (Fig. 6). This is largely due toMG6 technologies, including Artificial Intelligence and manufacturing robots, that reduce process steps and variability. ProSomnus also digitally or physically mounts and articulates every case for quality control. To further add value and reduce costs for the DSM practice, EVO comes standard with five arches. This enables 5.0mm of advancement and creates a built-in backup device if a patient loses an arch or a device (Fig. 7). The backup allows the patient to remain in some level of therapy until a replacement can be made. Figure 4 Figure 5