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Clinical evaluation of an enhanced white light and fluorescence device for early detection of caries lesions

机译:用于龋病早期发现的增强型白光和荧光装置的临床评估

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Objective: Sensitivity of a device based on Fluorescence Imaging with Reflectance Enhancement (FIRE) in detecting a potential incipient lesion (PIL) was compared with visual examination to demonstrate non-inferiority to it. ? Methods: Visual examination (VE) and an investigational device (ID) were used to detect PIL (actual incipient caries [AIC] and hypomineralization). Seventeen subjects satisfied data analysis criteria. Two-hundred and seventy-seven AIC and 367 hypomineralizations reached VE consensus. Ground truth was generated from consensus VE results and image information from enhanced white light (eWL) and FIRE images. Data from VE and ID in Still Image (IDSM) and Video (IDVM) modes were evaluated against ground truth. ? Results: Overall sensitivity of VE, IDSM, and IDVM evaluated against ground truth were 0.94, 0.884, and 0.848, respectively, for Actual Incipient Caries (AIC) detection, and 0.95, 0.916, and 0.883, respectively, for PIL detection. Sensitivity of ID in both modes was > 90% that of VE, thus demonstrating non-inferiority of IDSM and IDVM to VE. ? Conclusion: The investigated eWL and fluorescence device is clinically effective and at least as good as expert VE in detecting PIL. An enhanced white light device with FIRE technology can be used, in Video or Still Image Detection modes, as an aid to caries diagnosis.
机译:目的:将基于反射增强荧光成像(FIRE)的设备在检测潜在的初期病变(PIL)中的敏感性与目测进行比较,以证明其不逊色。 ?方法:使用视觉检查(VE)和研究设备(ID)来检测PIL(实际初期龋齿[AIC]和矿物质不足)。十七名受试者符合数据分析标准。 267个AIC和367个矿化不足达到VE共识。地面真相是从共识VE结果以及增强白光(eWL)和FIRE图像获得的图像信息中产生的。根据地面真相评估了静止图像(IDSM)和视频(IDVM)模式下来自VE和ID的数据。 ?结果:针对实际事故评估的VE,IDSM和IDVM对地面真实性的总体敏感性分别为0.94、0.884和0.848,对于PIL检测分别为0.95、0.916和0.883。在两种模式下,ID的敏感性均大于VE的90%,因此证明了IDSM和IDVM对VE的非劣效性。 ?结论:所研究的eWL和荧光装置在临床上可有效检测PIL,至少与专家VE一样好。在视频或静止图像检测模式下,可以使用具有FIRE技术的增强型白光设备来辅助龋齿诊断。

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