Continual Intra-oral pH Monitoring SystemA 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)
Quickstatistics
Problem
Turquoise Blue
Solution Results & Progress
Conclusion and Future Work
References
AcknowledgmentsQuick Project Stats
• 92% of Americans will experience tooth decay at some point in their lives1
• 200 million tooth restorations are performed annually in the United States2
• $124 Billion is spent annually between patients and insurers on dental care2
• 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 remineralize3
• 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
ContinualOral pH Sensor
Mobile Applicationto 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. NationalInstituteofDentalandCraniofacialResearch.DentalCaries(ToothDecay)inAdults(Age20to64).2018,Feb.Retrievedfromhttps://www.nidcr.nih.gov/research/datastatistics/dental-caries/adults
2. AmericanDentalAssociation,HealthPolicyInstitute.U.S.DentalExpenditures:2017Update.2017,https://www.ada.org/~/media/ADA/Science%20and%20Research/HPI/Files/HPIBrief_1217_pdf.PowerPointPresentation.
3. GordonJ.Christensen.CliniciansReport,Volume5Issue10:Addendum.2012.Retrievedfromhttps://www.cliniciansreport.org/uploads/files/55/Meds%20Cause%20Xerostomia.pdf.
