This agreement will allow dental practitioners to use the precise scans in a validated workflow as a basis to create a custom-made Digital Sleep Apnea Device (D-SAD).
Dentsply Sirona and Panthera Dental have announced a new partnership that will give dental practitioners the opportunity to use Primescan in a new area of application: Obstructive Sleep Apnea (OSA) and snoring. The condition of OSA, which affects up to 3.6 billion people worldwide, is a growing market. The agreement will create a validated and fully digital workflow for custom-made sleep devices.
Dentsply Sirona’s intraoral scanner Primescan, launched in 2019, enables digital impressions and can be used for patient consultation, treatment planning in implant dentistry and orthodontics, and restorative treatments. With the collaboration between Dentsply Sirona and Panthera Dental, dental practitioners can now use the scans in a validated workflow as a basis to create a custom-made Digital Sleep Apnea Device (D-SAD). The scan data delivers a custom-made D-SAD Mandibular Advancement Device (MAD), indicated for people suffering from Obstructive Sleep Apnea and snoring.
Dentsply Sirona’s Primescan reportedly captures a full-arch scan in as little as a minute to give the provider immediate control of a 3D model, says the company. The data transfer to Panthera Dental is designed to be fast and secure: for North America, Germany, France, Belgium, Netherlands, Luxembourg, United Kingdom, Australia and New Zealand, the data will be transferred securely via the Dentsply Sirona Connect Case Center. For other Primescan and Panthera Dental countries, the data can be sent via STL to Panthera Dental through their web portal (regulations per country and availability may vary). With one of the next software versions, there will be a full integration in the Connect Case Center for all Primescan and Panthera Dental-validated countries.
According to a press release from Dentsply Sirona, the workflow requires no additional equipment. After scanning the patient’s complete jaw and the bite registration for the protrusion, the scan data can be sent directly to Panthera Dental, either using the Connect Case Center or via STL-file. Within 15 days, the D-SAD will be designed and manufactured by Panthera Dental’s proprietary CAD/CAM process in their 4.0 manufacturing plant using numerous digital, robotic and automated technologies. It is then shipped back to the dental professional via multinational express delivery service. The dental provider receives a custom-made sleep device and can start treatment immediately.
Shouresh Charkhandeh, DDS, dental practitioner and dental sleep medicine educator from Canada, says, “Over one billion people worldwide suffer from sleep-related breathing disorders such as OSA. Many of them can benefit from Oral Appliance Therapy (OAT). We need to safely simplify OAT and make it predictable in order for many dentists to get involved in providing this life-saving treatment to patients. The validated digital workflow solution between Primescan and Panthera Dental, which combines Primescan’s impressive accuracy, efficiency, and ease of use, with Panthera Dental’s precise and versatile manufacturing, enables dentists around the world to help many suffering patients live a longer, better and healthier life and provide an alternative solution to CPAP therapy.”
Panthera Dental’s D-SAD is made out of 100% medical grade biocompatible type-12 polyamide nylon. This material is manufactured to be light, smooth, strong yet flexible, very durable and resistant to bruxism. A wide range of plateaus and bands are available and allow for over 300 standard design combinations as well as maximized tongue space. Additional customization is possible, and the D-SAD can be adapted to every possible patient morphology, from basic to the most complex.
According to Dentsply Sirona, the D-SAD’s unique titration mechanism uses interchangeable rods made of the same biocompatible polymer as the device, designed to not elongate and resist bruxism. The length of the rods varies from 16 to 34 mm and can be adjusted in 0.5 mm increments for an accurate and customized advancement. Moreover, they do not disengage during sleep due to a patented connection system and they are easily replaced.
“We are fulfilling an explicit request from customers and providing added value for dental professionals working with Primescan,” said Alexander Völcker, DDS, group vice president CAD/CAM at Dentsply Sirona. “The combination of Panthera Dental’s Digital Sleep Apnea Devices and Primescan is a great example of what can be achieved when a dental workflow starts with an intraoral scan. The digital technology integrates seamlessly into the daily workflow, enabling clinicians to provide a fast and accurate solution for sleep apnea and snoring.”
Beatrice Robichaud, co-founder and vice president of marketing and customer experience at Panthera Dental, said: “Our collaboration with Dentsply Sirona is a natural fit that will synergize both our companies’ recent technological advancements in the field of CAD/CAM solutions. Dental providers worldwide will benefit from the predictability of the validated Primescan workflow while delivering an accurate, completely customized Digital Sleep Apnea Device to their patients, for greater patient satisfaction and quality of life.”
The Panthera D-SAD received FDA 510(k) clearance for snoring and OSA has the CE mark and complies with the Canadian Medical Devices Regulations.