PHYSICAL SCIENCES INC. — Department of Health and Human Services SBIR Phase II: NIDCR

Description

Project Summary AbstractPhysical SciencesIncPSIin collaboration with The Forsyth InstituteCambridgeMA is proposing to develop a technology that will address a major unmet medical need in periodontologythe lack of tools to quantitatively and objectively assess the health disease status of the gingival soft tissuesThe proposed technology will combine high resolution micro Optical Coherence Tomography with Raman microspectroscopy for in vivo assessment of periodontal tissue integrity and therapy guidanceBoth Raman and OCT are powerful technologies with proven success in human tissue imagingavoiding the need for ionizing radiation exposuresWhile OCT allows for the visualization of soft tissue anatomyRaman is used to interrogate the biochemical composition of gingival tissuesas indicators of structural integrityThe complementary capabilities of these two optical technologies will be exploited to offer a clinically comprehensive set of parameters to more reliably and precisely determine the periodontal health statusDuring the Phase I program we performed a preliminary investigation of this powerful dual mode optical approach and demonstrated its capability for highlighting periodontal tissue morphological and biochemical changes that are not otherwise visible using any current clinically available toolsThe Phase I data indicated the potential of this technology for assisting clinicians in the diagnosis of periodontal health statusIn Phase II we propose to develop a clinically viable instrumentoptimize itand clinically evaluate its capability for assessing patient periodontal healthIn additionduring Phase II programpreliminary steps for technology commercialization and FDA regulatory approval will be takenThis innovative technology is of great clinical significance as it could provide clinicians with a novel diagnostic tool to detect early signs of periodontitis and accurately measure changes in intrinsic tissue properties to monitor disease activity in response to therapyThese will in turn allow for individualized therapeutic approaches for individuals at risk and poor responders to conventional therapywith significant potential for improving prevention and lowering healthcare costsOnce validated for periodontal tissuefuture applications may include the assessment of soft tissues around dental implants for early diagnosis of periimplant diseases Project NarrativeRaman microspectroscopyRMSand Optical Coherence TomographyOCTare powerful optical technologies for investigating biological tissue health statusThe combination of these technologies into an integrated hand held probe will enable noninvasive and real time screening and diagnosis of diseases around teethand dental implantswith high sensitivity and specificityThis could significantly reduce healthcare costs by diagnosing these diseases in their earlier stagewhen it is easier and less expensive to treatTotal current annual US expenditure on periodontal and peri implant procedures is on the order of tens of billions of dollars