Hand holding a 3D printed splint  | © Orthoplus

Revolutionizing Dentistry: 3D Printing Advances Dental Applications

OrthoApnea | Success Story

Enhancing Lives

Ortoplus’ innovative nylon splints for bruxism and TMJ disorders
  • Improved quality of life for 75,000 patients worldwide
  • High dimensional accuracy of less than ±0.1mm enhancing the fit and comfort of splints
  • 300% increase in production capacity without hiring additional staff
  • Reduce human errors with more flexible digital design workflow

Unfortunately, the number of patients affected and the clinical effectiveness of a treatment option alone can’t predict therapy success. While Obstructive sleep apnea (OSA) affects an estimated 9-38% of adults and studies suggest up to 90% of severe cases remain undiagnosed, traditional treatment hasn’t proven successful so far.

Similarly, bruxism, affecting 8-31% of adults, faces adherence issues with conventional treatments due to poor device fit and comfort. Leveraging the EOS FORMIGA P110 Velocis and Polyamide 12, Ortoplus has effectively addressed these challenges by utilizing a biocompatible material and flexible design capabilities. These advanced 3D printing solution enable the creation of custom-fitted, comfortable, and patient-specific medical devices, significantly improving patient adherence and outcomes in the treatment of OSA and bruxism.

3D printed nylon splint in a mouth of a woman | © Orthoplus
Customized 3D printed nylon splints to cure bruxism provide a better fit and comfort for the patient

Thanks to the advanced 3D printing technology, we've reduced our production time significantly, which means patients get their custom devices faster than ever."

Jesús García Urbano | CEO Ortoplus

Challenge

Treatments for bruxism typically involve stress management techniques, physical therapy, and the use of oral devices such as occlusal splints. However, for patients and dentists, the process can often be very cost- and time-intensive. Despite the effectiveness of occlusal splints, adherence to treatment can be low. Common reasons for discontinuing treatment include discomfort, difficulty keeping the splint in place during the night, and issues with fit or breakage. Due to the effort involved in traditional manufacturing processes, the untreated progression of bruxism often leads to extensive dental damage, requiring costly restorative treatments. Additionally, the associated pain and discomfort can significantly impact a patient’s quality of life, leading to further health complications and increased healthcare costs.

Similarly, sleep apnea, once diagnosed, is often not treated due to the limitations of current therapy options. Patients often need to trade in comfort for therapy effectiveness, and acrylic devices with bars and screws not only show higher failure rates but are also not sustainable. Although continuous airway pressure (CPAP) therapy is clinically effective, up to 50 percent of patients discontinue its use within the first year due to discomfort, claustrophobia, skin irritation, device noise, and difficulties in maintaining the device in place during sleep.

Precise & Stable

Custom-made splints alleviate discomfort for bruxism and sleep apnea patients

Close-up of a 3D printed splint  | © Orthoplus
Medical device with a surface finish that preserves the original color, avoids the accumulation of bacterial plaque and the changes caused by the passage of time
3D printed splint on a tray  | © Orthoplus
Medical device with a high resistance to wear, mouth forces and other impacts

Solution

Ortoplus has developed a state-of-the-art solution using Polyamide 12 and the FORMIGA P 110 Velocis, ensuring repeatable results at scale. It all starts with a patient's dentition record. Silicone trays must be digitized by scanning. Digital data collected using intraoral scanners can be directly subjected to a quality check. Based on this verified data, the devices are designed, 3D printed and post-processed. Once they have a very smooth finish, they undergo a final quality check to ensure that the devices are in optimal condition for delivery.

This workflow ensures the production of highly durable, biocompatible, and comfortable occlusal splints and mandibular advancement devices tailored to each patient's unique anatomy. The precision of 3D printing allows for the creation of customized solutions with high dimensional accuracy and homogenous material properties. PA 12 not only reduces the risk of allergic reactions and irritations due to metal parts, it’s also resistant to chemical degradation and mechanical wear, ensuring its durability in contact with body tissues, thus maximizing treatment efficacy. Since it can be sterilized using autoclaving and gamma radiation, it supports medical professionals in complying with the most stringent medical safety standards.

Thanks to the FORMIGA P110 Velocis and its ability to produce parts with complex geometries at scale, medical professionals are now able to promise patients a comfortable fit – all while shortening waiting periods. Even under continuous use and mechanical stress, PA 12 isn’t as susceptible to deformation as acrylic, and it also makes for a more ecologically friendly solution. Jesús García Urbano, CEO at Ortoplus concludes: "Thanks to the advanced 3D printing technology, we've reduced our production time significantly, which means patients get their custom devices faster than ever."

Results

Since the implementation of customized occlusal splints and MADs made with PA 12 and EOS 3D printing technology, Ortoplus has observed significant improvements in the quality of life for patients suffering from bruxism and sleep apnea. To date, their product OrthoApnea alone has helped 75,000 sleep apnea patients alleviate their symptoms. Ortoplus achieved this through the production of personalized medical devices with repeated high-quality. The Orthoapnea solution has been approved as a medical device under several major regulatory frameworks, including the FDA in the USA, MDD in the EU, MDEL in Canada, and TGA in Australia.

Compared to traditional manufacturing, 3D printing allowed triple production capacity with more repeatable and precise output quality – all without the need for new personnel. Being able to design devices digitally significantly reduced the risk of human error in production while further expanding design possibilities. The devices also demonstrated high dimensional accuracy of less than ±0.1mm, which significantly improved the fit and comfort of splints, contributing to the overall patient satisfaction and treatment efficacy. "Without the reliable results that Polyamide 12 delivers, we simply couldn’t do what we do. We looked at dozens of solutions in the market, none of which adhered to medical standards while allowing for an individualized fit like EOS 3D printing technology." Jesús García Urbano, CEO, Ortoplus.

Fit & Comfortable

Enhance patient adherence and reduce waiting times leveraging FORMIGA P110 Velocis and biocompatible PA 2200 material to create nylon occlusal splints and a mandibular advancement devices.

3D printed nylon splint in a mouth of a man | © Orthoplus
The properties of the material provide strength, lightness and flexibility to the device for greater comfort and ease of use during sleeping hours
OrthoApnea NOA product and packaging | © Orthoplus
OrthoApnea NOA is delivered in an exclusive packaging that transforms the reception of the MAD into an experience of great value

Without the reliable results that Polyamide 12 delivers, we simply couldn’t do what we do. We looked at dozens of solutions in the market, none of which adhered to medical standards while allowing for an individualized fit like EOS 3D printing technology."

Jesús García Urbano | CEO Ortoplus

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