RADIOGRAPHIC CONTRAST TO DIFFERENTIATE CAVITATED FROM NON-CAVITATED DENTAL CARIES

Firefly Health Innovations Ne, Inc., Omaha NE

Investigators

Abstract

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 tooth'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 (2013) measured sensitivity at only 18%. 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 18% to 70% or higher. Specificity will remain unchanged at 90+%. 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 noisy 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 116 tooth surfaces including 23 validated cavities, which will provide statistical proof of the sensitiity and specificity of CaviFind. Efficacy will be tested by 3 independent general dentists using blinded randomized control and test images. The gold standard will be a high resolution 3D scan of an impression of the IP surface.