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Continual Intra-oral pH Monitoring System A method to prevent tooth decay for extreme high risk patients Noah Hill (CS), Henri Schmidt (CS), Oliver Korten (CS) | Sponsored by Bill Gorman (Gorman Consulting) Quick statistics Problem Turquoise Blue Solution Results & Progress Conclusion and Future Work References Acknowledgments Quick Project Stats • 92% of Americans will experience tooth decay at some point in their lives 1 • 200 million tooth restorations are performed annually in the United States 2 • $124 Billion is spent annually between patients and insurers on dental care 2 • Tooth decay is caused by high levels of acidity for extended periods • When pH is below 5.5 teeth decay, when pH is above 5.5 teeth remineralize 3 • If oral acidity is consistently controlled, tooth decay can substantially prevented • However, current methods of checking oral pH (pH strip, pH probe) provide one-time results and are rarely used Data from a one-time measurement What actually happens throughout a day • Current care models are failing because they fail to capture the true story of oral pH profiles over time Continual Oral pH Sensor Mobile Application to Provide Real-Time Feedback Database to Store Long-Term pH Data Desktop App for Dentists with Long Term Analytics • Worn around one tooth on an orthodontic molar band • Takes pH reading every 15 min. and transmits to mobile phone • Worn continually for 6 months with no recharge or replacement • nRF52810 Bluetooth 5.2 SoC • Firmware in C with Nordic SDK • Embedded power supply • Notifies a patient when oral pH matches a potentially dangerous trend (set by dentist) • Personalized product recommendations to optimally neutralize pH for specific trends • Data sent to the cloud for long-term analysis • Built in Flutter for iOS and Android • Utilizes flutter_blue BLE library • Data stored between PostgreSQL and Timescale DB • Patients and dentists managed with AWS Cognito • Data accessed using AWS Lambda and API Gateway • Used by dentist at 6 month patient checkups to analyze data • Quickly pinpoint exact times unhealthy pH periods occur • Work with patient to understand causes of decay and develop personalized prevention strategy • High level analytics are provided • Web portal built with Flutter Web • Ported to desktop application with Electron • Successfully miniaturized our electronics to the size of two teeth (right most picture, Lego for scale) • Fully functional with regards to BLE stack, pH sensor performance, and power management • Designs for final one-tooth version have been created and are currently being produced • Verified reliable BLE transmissions can occur even when antenna is worn inside of the mouth • Final product casing designs have been created are are being optimized for various processes • DFM considerations for electroforming, electroplating, as well as injection molding • Built an algorithm to automatically generate the optimal molar band size based off an STL file • Patient does not need multiple visits to get sized, which is currently the industry standard • Firmware, mobile application and cloud infrastructure all successfully developed • Images of mobile application and web portal in the Solution section are real screenshots • Patient notifications have not been integrated, more dentist input is needed • Due to the intellectual property landscape surrounding medical device development, many design renderings and images are excluded from this poster. • If you would like to see more, please email [email protected] • Since Noah spent the year in Shenzhen, China, it was a challenge for the team to work together effectively across two countries and a 12 hour time difference • We learned a lot about project management and being flexible with early mornings and late nights • The integration of complex hardware and reliable software requires an incredible amount of careful planning • Very easy for development timelines to become uncoordinated and cause setbacks • Due to the successful outcomes of this project, Lura Health will be moving to Silicon Valley to fundraise a $3M seed round • After fundraising, the next steps will be some final development tweaks and entering the regulatory pathway as an FDA Class II medical device • Beyond oral pH, we believe saliva is the new blood of health diagnostics as it contains 1000s of analytes • Our vision is to become the platform for continual, personalized health monitoring with many applications • SOSV and the HAX Accelerator for funding Lura Health to work on this project and providing a world class workspace in the hardware development center of the world - Shenzhen, China • Bill Gorman, for sponsoring the project and providing outstanding quality and regulatory guidance • $600,000+ raised over course of project • 25+ PCB designs produced and tested • 18 consultants and companies worked with • 6 countries visited for business purposes • 2 SBIR grant submissions (NSF, NIH) • 2 patent applications submitted to USPTO • 1000+ cups of coffee drank 1. National Institute of Dental and Craniofacial Research. Dental Caries (Tooth Decay) in Adults (Age 20 to 64). 2018, Feb. Retrieved from https://www.nidcr.nih.gov/research/datastatistics/dental-caries/adults 2. American Dental Association, Health Policy Institute. U.S. Dental Expenditures: 2017 Update. 2017, https://www.ada.org/~/media/ADA/Science%20and%20Research/HPI/Files/HPIBrief_1217_pdf. PowerPoint Presentation. 3. Gordon J. Christensen. Clinicians Report, Volume 5 Issue 10: Addendum. 2012. Retrieved from https://www.cliniciansreport.org/uploads/files/55/Meds%20Cause%20Xerostomia.pdf.
