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Bioresorbable Nanoparticles for Visual Detection of Early-Stage Dental Caries

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DE027903-02
Agency Tracking Number: R44DE027903
Amount: $770,105.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDCR
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-16
Award End Date (Contract End Date): 2021-08-31
Small Business Information
3815 TECHNOLOGY BLVD, Lansing, MI, 48910-8121
DUNS: 080328777
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (517) 896-3665
Business Contact
Phone: (517) 896-3665
Research Institution
PROJECT SUMMARY ABSTRACT This project responds to the need identified by NIDCR to develop improved methods to detect and predict progression of dental cariestooth decayto improve human healthWorldwidecaries is the most common chronic disease affecting almost everyoneDental disease is a major cause of economic and social loss and leads to complications including paintooth loss and even deathGenerally inactive lesions require no treatment while active lesions doEarly active lesions permit conservative treatmentwhereas cavitated lesions require more costly and invasive restorationSince the earlyscaries diagnosis has been performed visually and using a dental explorerbut early cavities are missed and the explorer can cause cavitationAlternativelyXRays identify more fully developed cavities but are unable to identify early forming lesionsNewer methods for caries diagnosis show little benefit and incur greater cost to dentist and patientCurrent methods diagnose a surface defect in the enamel but cannot distinguishactivitya critical need in modern dentistryOur goal is to develop a new clinically valid test to diagnose early and active carious lesions that also enables effective monitoring of conservative treatmentWe have invented a nanoparticle technology which specifically targets active carious lesionsThe nanoparticles are made from food grade corn starch and have been functionalized to specifically target the subsurface of carious lesionsThey are tagged with a safe fluorescent dye so the caries will illuminate and be easily seen using a standard dental curing lampallowing dentists to quickly differentiate whether a carious lesion is active or inactive and to monitor treatment resultsThe product is a mouth rinse or oral gel containing a low concentration of the nanoparticles in waterenabling visual detection of early active carious lesions otherwise invisible on the tooth surfacebecause the extremely small nanoparticles can penetrate through surface microchannels into the early active sub surface lesionThe starch based nature of the nanoparticles facilitates rapid degradation by amylase enzyme present in human salivaso teeth will no longer fluoresce upon leaving the dentist s officeWith earlier detection of caries and treatment of the disease before cavitation occursinvasive treatments will be preventedresulting in the enablement of Minimally Invasive Dentistry and improved oral healthOur Phase I research has demonstrated the potential of this technologyand the functionalities on the nanoparticles were successfully optimized to provide a viable product with sufficient targeting and fluorescence contrast to be macroscopically visible by the dental professional on various tooth surfaces when using a standard dental curing light available in a dental practicePhase II involves in vitro assessment of the test s diagnostic capabilities including in vitro sensitivity and specificityin vivo biocompatibility and studies required for FDA submissionclinical feasibilityand scaling of productionSuccessful completion of the Phase II Aims will facilitate commercialization in Phase IIIand meet clinical developmentregulatory and manufacturing milestones to support clinical validation and longitudinal clinical outcome studies PUBLIC HEALTH RELEVANCE STATEMENT In this SBIRGreenMark Biomedical Incwill develop a diagnostic test which will be used by dental professionals as part of the routine dental exam to better detect and predict progression of dental cariesa need identified by NIDCRThe product will be a mouth rinse or oral gel product containing small fluorescent particles made from corn starchwhich are targeted into active carious lesions and illuminate when using a standard dental curing lamp found in every dental practiceIt will result in improved long term oral health outcomes for patients through greater conservative treatment and less overtreatment of dental caries

* Information listed above is at the time of submission. *

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