A method using three-dimensional scans of the patient’s face to produce individualized facemasks for the treatment of Class III malocclusions. Produced using additive manufacturing techniques (3D printers and specific resins), the resulting facemasks include pressure and temperature sensors linked to a mobile gaming app to promote treatment compliance and an app for therapy monitoring by the dentist.
Patent Status
GRANTED
Priority Number
102018000002713
Priority Date
15/02/2018
License
INTERNATIONAL
Market
Tooth misalignment resulting from malocclusions can lead to serious oral health problems if not treated early, preferably in childhood. Considering the global increase in the prevalence of malocclusions, in addition to the positive trend in cosmetic dentistry, this personalized medicine methodology will enable the coverage of a large market for orthodontic treatments, valued at US $40 billion, for which growth is estimated at 6.9% CAGR over the period 2022 – 2030.
Problem
Class III malocclusion is a maxillofacial disorder characterized by an advanced position of the mandible relative to the skull base and/or maxilla. This type of malocclusion should be treated in childhood, ideally before age 10, using a protraction facemask to improve dental occlusion and facial aesthetics. Although requiring an elevated patient compliance for optimal effectiveness of orthodontic correction (at least 12 hours per day, for at least 9 months), the mask is the least accepted device among orthodontic appliances. Currently marketed facemasks ill-fitted to the patient’s face often result in skin irritation due to the chin strap or elastics, gingival recession on the lower incisors, and decubitus, thus making therapy critical especially in the initial steps (49%). In addition, a critical factor seems to be the inability of medical staff to monitor the treatment (48%).
Current Technology Limits
Albeit effective, currently available facemasks on the market have several critical issues resulting in the child’s lack of cooperation in wearing the therapeutic appliance for the prescribed time (12 or 24 hours a day, for 9 to 12 months). Available in only two standard sizes, these masks are poorly ergonomic, being heavy and often ill-fitted to the forehead and chin. The forehead and chin supports often causes irritation and decubitus. Consequently, the perceived discomfort, bulkiness, and instability of the mask, in addition to poor aesthetics, represent additional sources of shame and embarrassment on the part of young patients.
Previous customization strategies include recording an alginate impression of a patient’s face, and the derived plaster model is used to fit the facemask components. Nevertheless, when in direct contact with the skin, alginate can be a source of discomfort for the patient. Alternatively, a PVC-based putty material applied to the inside of standard supports improved the fit of the pieced by taking the natural contours of the face, though not further facilitating treatment compliance.
Killer Application
The customized facemasks produced through the method find application in Digital Health, as it enable the monitoring of wear time based on reliable and accurate measurements. The presence of sensors ensures the continuous collection of accurate data, while avoiding data loss in the event of a sensor malfunction. Furthermore, the gamification approach, in addition to the device new ergonomics and the personalization thereof, can radically improve treatment compliance.
Our Technology and Solution
The SuPERPowerMe project bought the technology from TRL3 to TRL 7. The facemask manufacturing process has been consolidated with 3D scanning, modeling and printing. Face scans have been acquired with cameras from either an iPhone or iPad Pro tablet. 3D Blender was used for 3D modelling, and the components were 3D printed in BioMed Clear resin with Form 3 printer (Formlabs) and lined with foam pads. Mid-fidelity prototypes of all system components were developed. Bars were also 3D-printed in stainless steel. Temperature and pressure sensors were included in the forehead rest for wear time monitoring and connection with the game application.
From November 2021, the custom facemask with embedded sensors is currently tested in a clinical trial with 10 patients at the University of Firenze (Dipartimento di Medicina Sperimentale e Clinica, Ambulatorio di Ortognatodonzia, AOU Careggi).
Advantages
For patients, the technology produces a custom facemask, smaller and lighter than standard devices, modeled on the patient’s face and 3D printed with biocompatible materials to fit perfectly, decrease discomfort and side effects, ultimately conferring effectiveness and comfort. The gamification approach, consisting of a gaming app linked to the embedded sensors, results in a more playful and fun therapy, thus promoting motivation to follow the treatment. Indeed, the system introduces a playful approach to therapy in which the facemask transforms the patient into a superhero through a catalog of decorations inspired by the world of superheroes for further customization of the device aesthetics.
For orthodontists, the technology includes a system of sensors built into the mask to monitor wearing time. A docking station recharges the battery and sends the data collected by the mask to a web app intended for orthodontists. Through the web app, physicians are therefore able to remotely monitor the progress of the therapy, offering reliable quantitative data to evaluate the overall therapeutic progress.
Roadmap
The hardware and software system is being developed, tested and integrated to move from experimental concept to high-fidelity prototypes. The use of sensors for wear time monitoring and gamification of the therapy can be extended to any removable orthodontic/orthopedic appliance that requires patient’s compliance, such as headgears for the treatment of Class II malocclusions and removable retainers.
The use of sensors for wear time monitoring and gamification of the therapy could also be extended to other wearables that require the child’s compliance, such as glasses and ocular patches used in Pediatric Ophtalmology.
TRL
Team
