Clinical Performance of DIAGNOdent Pen for Occlusal Caries Detection

Objectives: To determine the clinical performance of a laser fluorescence device (DIAGNOdent pen, KaVo) to discriminate between different caries depths (D₀-D_1-4; D_0,1,2-D_3,4; D_0-3-D₄) in occlusal caries diagnostics at permanent molars.

Methods: In this prospective, randomized two-centre-study 120 sound/non-cavitated carious sites (patients n=120; 1 site/patient) were measured by 4 calibrated dentists after visual/radiographic caries assessment. In cases of operative intervention (n=86), the lesion depths after caries removal were recorded (reference). In cases of preventive intervention (n=34), the sites were recorded and reassessed visually/radiographically after 12 months to verify the status assessed before (reference). The differences in measurements between the caries depths were analyzed by the Mann-Whitney test. Next to receiver operating characteristic curves (ROCs), sensitivities (SE) and specificities (SP) were plotted against the measured values. Those values at the intersections of SE and SP curves were suggested as possible cut-offs for the different thresholds. The overall-correlation between the measurements and the caries depths were given by the Spearman's rho coefficient.

Results: The measurements of sound sites (n=13) were significantly less than of carious sites (n=107) (p<0.0001). This was the same comparing measurements of no/enamel caries (n=63) and dentinal caries (n=57) and of D_0-3 (n=104) and D₄ (n=16). The areas under the curves for the same discriminations were 0.92, 0.78 and 0.75 (p<0.001). For the D₀-D_1-4 threshold, the cut-off was at a value of 12 (SE: 0.88, SP: 0.85), for the D_0,1,2-D_3,4 threshold at 23 (SE: 0.72, SP: 0.71) and for the D_0-3-D₄ threshold at 27 (SE: 0.62, SP 0.65). Altogether, a moderate positive correlation between the measurements and the caries depths was calculated (rho=+0.57, p=0.01).

Conclusion: Within this study, the device's discrimination performance for different caries depths was very good to moderate. It can be recommended as adjunct tool in the caries diagnostic process of non-cavitated occlusal sites at permanent molars.