GreenMark Biomedical Inc., 1600 Huron Parkway Building 520, Room 2399, Ann Arbor, MI 48109, United States.
GreenMark Biomedical Inc., 1600 Huron Parkway Building 520, Room 2399, Ann Arbor, MI 48109, United States.
J Dent. 2022 Oct;125:104243. doi: 10.1016/j.jdent.2022.104243. Epub 2022 Jul 27.
We have previously shown fluorescent cationic starch nanoparticles (FCSNs) penetrate enamel surface porosity of active carious lesions, potentially aiding their detection. Here, we evaluate the in vitro diagnostic accuracy of FCSNs in detecting occlusal caries compared to histologic reference standard.
100 extracted human teeth were selected with sound (50), or either non-cavitated (25) or cavitated (25) lesions. A region of interest (ROI) on the occlusal surface was assessed for fluorescence by two independent examiners, after immersion in FCSN solution, water rinse, and illumination by dental curing lamp viewed through orange UV-filter glasses. ROIs were sectioned and evaluated by histology (Downer Criteria) as a gold standard for caries presence. Cohen's Kappa was determined for inter- and intra-examiner agreement, and sensitivity, specificity, and area under the curve of Receiver Operator Curves (ROC) were calculated. The analysis was repeated for the subset of "early" lesions, defined as being limited to enamel.
FCSN use resulted in substantial inter-user (k=0.74±0.07), and high intra-user agreement (k=0.80±0.06; 0.94±0.03, by examiner). Sensitivity, specificity and ROC for FCSNs were 88.9%; 94.6%; 0.92±0.06 for all, and 76.9%, 94.6%, and 0.86±0.10 for early lesions. In post hoc analysis, sensitivity seemed to be greater with the FCSN than the expert visual exam, particularly for early lesions.
CONCLUSIONS/CLINICAL SIGNIFICANCE: FCSNs are a reproducible and accurate novel technology for occlusal caries detection, with high sensitivity and specificity compared to histology. Future clinical validation is necessary. FCSNs can improve early caries detection and shift treatment towards non-invasive approaches, improving oral health.
我们之前已经证明，荧光阳离子淀粉纳米粒（FCSN）能够穿透活跃龋损的牙釉质表面孔隙，从而有可能辅助龋损的检测。本研究旨在评估 FCSN 检测窝沟龋的体外诊断准确性，并与组织学参考标准进行比较。
选择 100 颗从患者口腔中拔出的人牙，其中 50 颗牙釉质完整，25 颗牙釉质存在非龋性缺损，25 颗牙釉质存在龋性缺损。将牙齿的咬合面置于 FCSN 溶液中浸泡，然后用清水冲洗，最后用橙色紫外线滤光片的牙用固化灯照射，由两位独立的检查者评估感兴趣区域（ROI）的荧光。将 ROI 进行切片，通过组织学（Downer 标准）评估作为龋病存在的金标准。采用 Cohen Kappa 检验评估两位检查者之间以及同一检查者内部的一致性，计算敏感性、特异性和受试者工作特征曲线（ROC）的曲线下面积（AUC）。该分析针对局限于牙釉质的“早期”病变子集重复进行。
FCSN 的使用导致了两位使用者之间（k=0.74±0.07）以及同一使用者内部（k=0.80±0.06；0.94±0.03）具有较高的一致性。FCSN 的敏感性、特异性和 ROC 分别为 88.9%、94.6%和 0.92±0.06，早期病变的敏感性、特异性和 ROC 分别为 76.9%、94.6%和 0.86±0.10。事后分析显示，FCSN 的敏感性似乎高于专家视觉检查，特别是对于早期病变。
结论/临床意义：FCSN 是一种可重复、准确的新型窝沟龋检测技术，与组织学相比具有较高的敏感性和特异性。未来需要进行临床验证。FCSN 可以提高早期龋病的检测能力，推动治疗向非侵入性方法转变，从而改善口腔健康。
