FIREFLY HEALTH INNOVATIONS NE, INC. — Department of Health and Human Services STTR Phase II: NIDCR

Description

DESCRIPTION provided by applicant This project aims to improve the accuracy of tests for early tooth decay dental caries specifically for interproximal surfaces where the posterior teeth abut one another In these regions there is no physical space to visually inspect or probe for caries Instead dentists rely on bitewing X rays BWs But dentists cannot tell whether lucencies observed on the BWs are cavitated decay a hole to the toothandapos s surface or merely non cavitated decay under the surface of the tooth This earlier non cavitated decay often does not need to be restored with a filling and can be treated non surgically instead However our phase I research revealed that dentists cannot accurately differentiate interproximal enamel cavities from non cavitated decay and a recently published paper by Wenzel et al measured sensitivity at only This low sensitivity can lead both to significant over treatment and under treatment resulting in poor health outcomes and substantial economic waste The developed test uses a liquid radiographic contrast agent dense material placed on the interproximal tooth surfaces before taking routine BW X rays The liquid will enter any cavitated decay holes and appear white under the tooth surface clearly distinguishing it from healthy teeth or those with only non cavitated decay where there is no hole for the liquid to penetrate Hypothesis Use of radiographic contrast will increase detection of early interproximal cavitated decay from a sensitivity of to or higher Specificity will remain unchanged at Method Our Phase I work achieved proof of concept by demonstrating that liquid contrast successfully penetrates into interproximal cavities But controlling the exact location and quantity of liquid dispensed was problematic For this reason some images appeared andquot noisyandquot with excess contrast appearing along the gum lines and in the interproximal spaces making images harder to interpret Other interdental variations also could not be sufficiently accounted for or controlled with off the shelf applicators For this reason a customized applicator has been formulated and will be developed and tested in Phase II to create a commercially viable applicator After development and small scale testing we will then perform a clinical trial of tooth surfaces including validated cavities which will provide statistical proof of the sensitiity and specificity of CaviFind Efficacy will be tested by independent general dentists using blinded randomized control and test images The gold standard will be a high resolution D scan of an impression of the IP surface PUBLIC HEALTH RELEVANCE Dentists cannot accurately determine whether early interproximal tooth decay is cavitated and requires a filling or non cavitated and generally does not require a filling New research indicates that dentists accurately detect early cavitated interproximal decay less than of the time but will fill of all such decay suggesting substantial diagnostic inaccuracy based on current methods of assessing tooth decay Fireflyandapos s new imaging test an adjunct to the X rays dentists already take greatly increases accuracy of interproximal caries detection creating the potential for greatly improved health outcomes and the potential for tens or hundreds of millions of dollars in cost savings