Performance of ICDAS II and fluorescence methods on detection of occlusal caries—An ex vivo study

Journal Pre-proof Performance of ICDAS II and fluorescence methods on detection of occlusal caries—An ex vivo study Grazyna Marczuk-Kolada, Elzbieta Luczaj-Cepowicz, Marta Obidzinska, Janusz Rozycki

PII:

S1572-1000(19)30555-1

DOI:

https://doi.org/10.1016/j.pdpdt.2019.101609

Reference:

PDPDT 101609

To appear in:

Photodiagnosis and Photodynamic Therapy

Received Date:

21 May 2019

Revised Date:

20 November 2019

Accepted Date:

22 November 2019

Please cite this article as: { doi: https://doi.org/ This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier.

Performance of ICDAS II and fluorescence methods on detection of occlusal caries - an ex vivo study Grażyna Marczuk-Koladaa*, Elzbieta Luczaj-Cepowicza, Marta Obidzinskaa, Janusz Rozyckib

a

Department of Pedodontics, Medical University of Bialystok, Waszyngtona Str. 15a, 15-297

Bialystok, Poland b

Department of Radiology, Medical University of Bialystok, M. Curie-Sklodowskiej Str. 24a,

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15-274 Bialystok, Poland

*Corresponding author: Grazyna Marczuk-Kolada, Department of Pedodontics, Medical

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University of Bialystok, Waszyngtona Str. 15a, 15-297 Bialystok, Poland;

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phone number/fax : +48 85 7450961; e-mail address: [email protected]

Highlights

ICDAS II and VistaCam iX showed the highest sensitivity of detecting early caries

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VistaCam iX was characterized negligible sensitivity of detecting dentin lesions



VistaCam iX was characterized by the highest values of the area under the ROC curve

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Modern devices using fluorescence can be a supplement to visual caries diagnosis

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Abstract

Background: The aim of the ex vivo study was to compare the performance of the visual ICDAS

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II scale and two fluorescence methods (DIAGNOdent Pen and VistaCam iX) in detecting occlusal caries lesions in permanent teeth using cone beam computed tomography (CBCT) as a reference test.

Methods: One hundred-sixty molars and premolars were qualified for the study. The visual, the DIAGNOdent Pen and VistaCam iX examinations were carried out by two examiners. The actual extent of the lesions was determined using CBCT. For the three methods, inter- and intraexaminer reproducibility was calculated using intraclass correlation coefficient. The sensitivity,

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specificity, and accuracy of these methods were compared using the mid-P McNemar test. The level of significance was set at p < 0.05. Results: For all data, intraclass-correlation coefficients (ICC) for intra- and inter-examiner reproducibility were high. With regard to the enamel threshold, the sensitivity and accuracy were significantly higher for VistaCam iX and ICDAS II compared with the DIAGNOdent Pen (p < 0.05). The results obtained with the DIAGNOdentu Pen indicated significantly higher specificity values for the enamel threshold (p < 0.05). The results obtained with the VistaCam iX showed the lowest sensitivity but the significantly highest specificity and accuracy for the dentin threshold (p < 0.05).

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Conclusions: The ICDAS II is an effective method for detecting early carious lesions, characterized by a higher sensitivity compared with devices using fluorescence. To improve the diagnostic efficiency of the evaluated devices, modifying the cut-off values recommended by the manufacturers should be considered.

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Keywords: Occlusal caries detection; ICDAS II; Fluorescence methods; Cone beam computed

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tomography

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1. Introduction

Accurately diagnosing occlusal pit and fissure caries and detecting incipient lesions are important issues for clinicians. This requires using diagnostic methods enabling the detection

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of caries lesions and the assessment of their severity in order to properly select the therapeutic methods.

The effectiveness of caries lesion detection depends on their location. Problems with the

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diagnosis of occlusal surfaces are affected, among others, by the diversified fissure and pit morphology and the surface remineralization potential of fluoride-containing preparations

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[1,2,3]. This causes an increase in the number of hidden caries lesions that spread in the dentin below the surface of the clinically intact enamel [4]. A result of misdiagnosis is selecting the wrong treatment method and, consequently, caries progression. In recent years, the criteria for the visual evaluation of caries lesions have been modified by introducing the ICDAS II criteria and many additional devices that are intended to increase the effectiveness of caries diagnosis [2,3,5]. The caries development process causes disorders in the mineralized tissue structure, appearing as changes in their fluorescence. Hibst et al. [6] showed that porphyrins are 2

responsible for the fluorescence level in carious tissues. They appear as an intermediate step in heme synthesis and can also be produced by several types of bacteria found in the oral cavity, such as: Prevotella intermedia or Porphyromonas gingivalis. Caries are diagnosed when the ratio of red to green fluorescence is higher than that of healthy tissue [7]. Devices that use fluorescence in the diagnosis of caries are: VistaCam iX (Dürr Dental, Bietigheim-Bissingen, Germany) and DIAGNOdent Pen 2190 (Kavo, Biberach, Germany). There is no reports in the available literature comparing the effectiveness of the VistaCam iX with the DIAGNOdent Pen 2190 in detecting early caries lesions. When assessing the effectiveness of diagnostic methods, their sensitivity, specificity,

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accuracy as well as their reproducibility and unambiguity should be taken into account [8]. The values of these parameters should be verified by a reference examination, referred to as the gold standard. Whereas histologic examination is used to detect the extent of caries lesions, microCT and radiological methods could be used as non-destructive methods with high accuracy [5,915]. Kamboroğlu et al. and Ertas et al. points to high accuracy in occlusal caries lesion detection

caries depth measurement in ex vivo studies [12,14].

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using Cone Beam Computed Tomography (CBCT), and recommends this method for dental

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The aim of the ex vivo study was to compare the performance of the visual ICDAS II scale and two fluorescence methods (DIAGNOdent Pen and VistaCam iX) in detecting occlusal

standard).

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2. Materials and methods

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caries lesions in permanent teeth (molars and premolars) using CBCT as a reference test (gold

2.1. Preparation of samples

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The study protocol was approved by the Ethics Committee of the Medical University of Bialystok (no. R/I/002/170/2016) and conformed to the tenets of the Declaration of Helsinki.

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Two hundred teeth were extracted as a result of orthodontic, periodontal, or surgical

indications. After preliminary visual examination, 160 molars (including third molars) and premolars were qualified for the study and 40 teeth were used for calibration. The inclusion criteria for occlusal tooth surfaces in the study were: no signs of caries, noticeable opacity, or white/brown discoloration that did not match the appearance of healthy enamel. The criteria excluding teeth from the study included: the presence of fissure sealants, fillings, hypomineralization, or lesions with cavitation.

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Immediately after the extraction, the teeth were rinsed under running water and then stored in a freezer (-18˚C) for 2 months [16]. After a 4-hour defrosting, the teeth root surfaces were cleaned using a dental scaler. Next, the occlusal surfaces were cleaned using a slow-speed tip with pumice and a bristle brush. After thoroughly rinsing the remains of the pumice with an air/water spray, the teeth were individually placed in a wax plate and were stored in an incubator (24°C and 100% humidity) for 4 hours, followed by moistening of the occlusal surface with physiological saline (wet examination) and air drying for 5 seconds (dry-examination). Examination was conducted by 2 examiners, in a room with artificial light from an KaVo Promatic dental unit lamp (KaVo Dental GmbH, Germany), selecting one suspected spot on

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each occlusal surface, as follows:

2.2. Visual examination (ICDAS II)

The ICDAS II (International Caries Detection Assessement System) was used:

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code 0 – sound tooth surface,

code 1 – first visual change in enamel: 1w (white) or 1b (brown),

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code 2 – distinct visual change in enamel: 2w (white) or 2b (brown),

code 3 – localized enamel breakdown due to caries with no visible dentin or underlying shadow,

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code 4 – underlying dark shadow from dentin with or without localized enamel breakdown, code 5 – distinct cavity with visible dentin,

code 6 – extensive distinct cavity with visible dentin [17,18].

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Code 3 was the cut-off threshold for dentin lesions. Prior to the visual examination, both examiners used training software on the ICDAS web site [19]. After training, the dentists examined the occlusal surfaces of the teeth separately in two sessions, with a 2-week interval.

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The second examiner evaluated the teeth in the same sequential order. Between examinations, the teeth were frozen and stored, as previously described. The measurements were done

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independently and the examiners were blinded to their peer’s scores. The occlusal surfaces of stabilized teeth were photographed with a digital camera (Canon

Eos 450d, 100mm, F2.8 EF macro) mounted on a tripod. Then, using a graphic program (GIMP 2.8.22), selected areas were marked on the digital images. This procedure enabled precise determination of the location of the examined area at every stage of the experiment. The examined teeth were given subsequent ordinal numbers.

2.3. DIAGNOdent Pen examination 4

After digital imaging, an examination was carried out using the DIAGNOdent Pen (Kavo, Biberach, Germany), with a 655nm red laser with 1 mW. After processing the data in the microprocessor, the device screen displays two values on a scale from 0 to 99. One of them is the temporary value (“moment”) and the second is a record of the highest value obtained during the test (“peak”) [20]. Double calibration was done and then the probe was applied at the designated location and rotational movements were performed to evaluate all fissure walls and to correctly determine the maximum value. The obtained results were interpreted in accordance with the scale developed by the manufacturer [6,20]: 

0-13

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14-20 - enamel caries,

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21-29 - caries in the dentin-enamel junction,

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>29

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- sound,

- dentin caries.

Assessments were done twice by the same two examiners (examiner 1 and 2), with a 14-day

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interval between measurements. Between the examinations, the teeth were frozen as described

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above.

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2.4. VistaCam iX examination

When using the VistaCam iX (Dürr Dental, Bietigheim-Bissingen, Germany), the colour scale provide reliable information on carious lesions. Individual colors are assigned appropriate

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numerical values on a scale of 0 – 3, reflecting the advancement of the caries process [2,21]. The study was conducted in a darkened room, without the use of artificial light. After opening the DBSWIN program (Dürr Dental, Bietigheim-Bissingen, Germany) and creating a new data

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directory, photographs of the occlusal surfaces were taken using the Proof tip. On the image, the examined area was located, and then it was evaluated in the caries diagnosis mode and the

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obtained value was noted. Each image was assigned the appropriate number, which was saved in the program. The results were interpreted according to the manufacturer's scale [21,22]: 0-1

- (green color) healthy tooth,

1.1 - 1.5

- (blue color) beginning of enamel caries,

1.6 - 2.0

- (red color) enamel caries up to the dentin-enamel

junction,

5

2.1 - 2.5

- (orange color) dentin-enamel junction crossed,

>2.5

- (yellow color) deep dentin caries.

2.5. CBCT examination

The examination was conducted at the Department of Radiology of the Medical University in Bialystok. In a styrofoam plate, 3 teeth were placed at intervals of 1 cm, and then scanned with NewTom 5G (Quantitative Radiology, Verona, Italy) in a 6x6 imaging field (110 kV, 10.82 mA, 78.62 mAs, 7.3 s). Reconstructions were done using NNT Viewer version 7.2

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(Quantitative Radiology, Verona, Italy) . Coronal, sagittal, and axial planes were obtained (thickness of the imaging layer was 0.075 mm). Areas under investigation were located on the coronal plane by one of the researchers who compared them with digital photographs of the teeth. Then, the marked areas were interpreted by two researchers who did not participate in the

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previously conducted diagnostic examinations. In cases in which the two investigators’ ratings diverged, a joint assessment was performed until consensus was reached. In the assessment,

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program software functions such as change of focus and enlargement were used. Teeth were classified depending on caries lesion severity into the following groups: 0 - no lesions,

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E1 - lesion occurring in the outer half enamel layer,

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E2 - lesion occurring in the inner half enamel layer,

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D1 - lesion occurring in the outer third dentin layer,

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D2 - lesion occurring in the middle third dentin layer.

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2.6. Statistical analysis

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Statistical analysis was performed using IBM SPSS Statistics 20.0 software (StatSoft,

Cracow, Poland). Both examinations were repeated 2 weeks later to assess the intra- and interexaminer reproducibility. For the two methods, inter-examiner reproducibility was calculated for the examiners, and intra-examiner reproducibility was calculated for the trained examiners using intraclass correlation coefficient (ICC). The sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) of the tested methods were determined in relation to the cut-off values recommended by the manufacturer [23,24]. The accuracy of a test is its ability to differentiate the healthy occlusal surfaces correctly. PPV is 6

proportion of positive results that are true positive and NPV is proportion of negative results that are true negative. The sensitivity, specificity, and accuracy of these methods were compared using the mid-P McNemar test [23-25]. The diagnostic value of the methods was determined by creating Receiver Operating Characteristic (ROC) curves, which is a graphic representation of the relationship between the percentage of true positive test results (sensitivity) and the percentage of false positives (1-specificity). The curve created in this way, and in particular the area under it (AUC - area under the curve), enables direct assessment of the diagnostic power of the tested method. It also applies to determining the optimal cut-off point that divides the assessed population into two groups: one in which disease is present and

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one with no disease. The optimal cut-off test value (with the highest possible sensitivity at a high specificity) was determined using the Youden index. The Youden index (J) is a function of sensitivity and specificity defined by J=maximum {sensitivity + specificity-1}. This index ranges between 0 and 1, with values close to 1 indicating that the method effectiveness is relatively large [26].

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For both methods, cut-off points were found for which the Youden index was the highest, as well as method sensitivity and specificity for the new cut-off values. These parameters were

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determined separately for the enamel threshold and the dentin threshold.

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Results were considered statistically significant when the calculated probability of p < 0.05.

3. Results

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For all data, intraclass-correlation coefficients (ICC) for intra- and inter-examiner reproducibility were high and were between: 0.73-0.88 for ICDAS II, 0.75-0.87 for DIAGNOdent Pen, for VistaCam iX 0.83-0.91 and 0.83-0.91 for CBCT (Table 1).

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Based on the assessment of images obtained in the CBCT examination, we found that 69 of the surfaces were healthy (0), 24 of the lesions included the outer half of the enamel (E1), and

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42 the inner half of the enamel (E2). In the case of dentin, 23 of the lesions occurred in the outer part and 2 the middle. Cross-tabulation for ICDAS II, DIAGNOdent Pen and VistaCam iX with the corresponding CBCT were given in tables 2 and 3. Table 4 presents the sensitivity, specificity, accuracy, positive predictive value (PPV),

negative predictive value (NPV), and AUC (area under curve ROC) for ICDAS II, DIAGNOdent Pen, VistaCam iX and CBCT at the enamel and dentin thresholds. With regard to the enamel threshold, the sensitivity was significantly higher for VistaCam iX and ICDAS II compared with the DIAGNOdent Pen (p < 0.05). The results obtained with the 7

DIAGNOdentu Pen indicated significantly higher specificity values (p < 0.05). Accuracy for the VistaCam iX was significantly higher compared with the DIAGNOdent Pen (p < 0.05). The VistaCam iX had the lowest sensitivity and the highest specificity for the dentin threshold. Accuracy was significantly the lowest for the DIAGNOdent Pen compared with ICDAS II and VistaCam iX. A summary of the values of sensitivity, specificity, the area under the curve (AUC), and the cut-off points with reference to the thresholds provided by the manufacturers as well as our own (the highest Youden index value) is presented in Table 5. When verified using CBCT, the DIAGNOdent Pen results suggested that at a value above

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21.13, enamel caries occur. This value is higher than the device manufacturer indicated (>13). The obtained highest values of the Youden index for dentin lesion detection indicate their occurrence at DIAGNOdent Pen indications above 24.75. In the case of dentin damage, this value is lower than that suggested by the manufacturer (>29).

The estimated optimal cut-off value for the detection of enamel lesions in the case of the

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VistaCam iX with CBCT verification was higher (>1.29) than that recommended by the manufacturer. For dentin lesions, the optimal cut-off point was lower (>1.51). It should be

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emphasized that when using the optimal cut-off point for dentin lesions the sensitivity of the

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method increased significantly.

4. Discussion

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In current visual diagnostics, the ICDAS II visual scoring system based on subjective interpretation is recommended. In the present study, we used the ICDAS II system and two devices using fluorescence, the DIAGNOdent Pen and the VistaCam iX, to assess carious

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lesions on the occlusal surfaces of permanent teeth. We used Cone Beam Computed Tomography (CBCT) to verify the extent of carious lesions in all teeth qualified for the study.

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Kamboroglu et al. compared various radiological methods to assess the depth of carious lesions by verifying them with histological examination [12]. They found that CBCT gives better assessment results on the depth of the carious lesions on occlusal surfaces compared with conventional radiological intraoral method. They also indicated that CBCT can be recommended as a non-destructive method of evaluating carious lesions ex vivo [12]. In the available literature, we didn't find any papers describing the use of volumetric tomography to assess the effectiveness of the ICDAS II system and fluorescent diagnostic methods in ex vivo experiments. 8

All diagnostic methods were characterized by high measurement reproducibility and unambiguity. The high values of these parameters indicate the possibility of using a given method to monitor carious lesions and evaluate the effectiveness of prophylactic procedures. Our results of intra- and inter-examiner reproducibility for the ICDAS II are confirmed in other papers [5,27,28,29]. In the case of the DIAGNOdent Pen, intra-examiner reproducibility was similar and inter-examiner reproducibility was lower than what Rodrigues et al. presented in their study [13]. In our study using the VistaCam iX, both the reproducibility of the test results and the inter-examiner reproducibility ranged from 0.83 to 0.91. Other authors noted equally high values of these parameters [2,13,22,30].

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It is difficult to physically detect early carious lesions, even if there are reliable clinical criteria for diagnosing noncavitated lesions. Analyzing the results of the present study, we can conclude that the ICDAS II is characterized by the highest sensitivity values for the enamel and dentin threshold. Our ICDAS II results for the enamel threshold were concordant with the results of other authors [22,27,28,29].

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In our results, the main problem with the enamel threshold is low specificity which tends to generate more false-positives readings. This means that a large number of sound sites can be

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incorrectly scored as carious. According to authors many factors affect the diagnosis. In visual examination, the differences in specificity values may be connected with fissure depth and its

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discoloration, stains, fluorosis and developmental defects [4,5,29]. When using devices using fluorescence, dentists should remember that calculus, plaque, composite filling materials, remnants of polishing pastes, and stains may produce fluorescence and therefore cause false-

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positive readings [31,32].

In case of unclear diagnosis, it is recommended for the sound surface or early stage caries to receive preventive care such as using fluoride or sealant, rather than irreversible surgical

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procedures [10,33]. It is also recommended monitoring and control the progression of early carious lesions by combining a visual examination with adjunctive devices [10,33].

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In the present study, we assessed the DIAGNOdent Pen parameters using the guidelines

contained in the instructions (>13). Aktan et al. adopted the same cut-off value for the enamel threshold [1]. They showed a sensitivity of 0.65, which was comparable to that obtained in the present study. Jablonski-Momeni et al. noted a higher sensitivity (0.83) with a cut-off value of >6 [34]. Iranzo-Cortes et al. provided a specificity of 0.53 [27]. The sensitivity values we obtained for the dentin threshold (0.48) were lower than for the enamel threshold. Other authors had similar observations [1,34,35]. The second evaluated tool using fluorescence was the VistaCam iX, a newer version of the VistaProof. There are few reports on its effectiveness in 9

the literature, however, there are papers available pertaining to its older version [2,7,13,22,28,30,34,36]. The VistaCam iX was characterized by a similar sensitivity for the enamel threshold to the ICDAS II and a higher sensitivity than the DIAGNOdent Pen. Accepting the manufacturers' cut-off values, this device had negligible sensitivity but high specificity in detecting dentin lesions. Researchers from Greece assessed three diagnostic methods: the ICDAS II, the VistaProof, and the DIAGNOdent Pen [28]. Similarly to us, they observed that the sensitivity of the DIAGNOdent Pen in the detection of enamel lesions, accepting 13 as a cut-off value, was the lowest of the methods used. Other authors drew similar conclusions indicating that in the case of dentin lesions the device surpasses the VistaCam iX

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in terms of the value of this parameter [37]. We noticed that the ICDAS II demonstrated the highest sensitivity for diagnosing dentin lesions, followed by the DIAGNOdent Pen and the VistaCam iX. Kockanat et al. applied the above diagnostic methods in their work, with the exception of the VistaCam iX, replacing it with another device using fluorescence. When assessing enamel lesions, they noted the same dependencies between the sensitivity values of

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the examined devices [38].

The results of our study showed acceptable diagnostic accuracy for the ICDAS II, the

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DIAGNOdent Pen, and the VistaCam iX. Therefore, it can be concluded that combining the different systems can be useful for detecting lesions and would be the best choice for detecting

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caries on occlusal surfaces, which is confirmed by our study results, and as suggested by some authors [13,31,32].

The discussed diagnostic parameter results were obtained based on the guidelines provided

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by the device manufacturers. On the basis of the data analysis, we also defined our own threshold values for which the Youden index has the highest value. The optimal cut-off value for detecting lesions with the DIAGNOdent Pen for the enamel threshold was >21.13. Based

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on the results of the current study, it can be assumed that dentin lesions occur at DIAGNOdent Pen indications of at least 24. In the case of the VistaCam iX, the manufacturer provides a value

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of 1.0 as above which there are early carious lesions. Based on the results of the current study, this cut-off should be moved to 1.29. This is confirmed in the studies of Jablonski – Momeni et al., who set this threshold at 1.2/1.3 [22,30]. We found that in the case of dentin lesions, the cut-off above which one should suspect their occurrence is 1.51. This value is about 0.5 lower than that suggested by the manufacturer. Other researchers reduced this cut-off value to a similar level [13,22,30]. The next parameter assessed in this paper was the area under the ROC curve (AUC). On the basis of the conducted study, we found that the ICDAS II and the tested devices obtained 10

satisfactory AUC values, which indicates their diagnostic usefulness. For the enamel threshold, the ICDAS II had the highest AUC values, followed by the VistaCam iX and the DIAGNOdent Pen; and for the dentin threshold, it was the VistaCam iX, followed by the ICDAS II and then the DIAGNOdent Pen. These results were concordant with other authors' results [1,13,34]. The VistaCam iX was characterized by higher sensitivity for the new cut-off value, for both the enamel and the dentin lesion progression thresholds, compared with the DIAGNOdent Pen. In clinical conditions, this means that more carious lesions can be properly diagnosed. In vitro studies should be conducted in a way as close as possible to clinical conditions. Various factors, and above all, the way samples are stored, may affect the obtained results

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[16,39]. The storage substances could change the fluorophore concentrations in samples as well as the optical properties of hard tissues. According to the results of other studies, storing samples in low temperatures, without any kind of media (storing solution), creates close to clinical conditions. According to the authors teeth stored in formalin, chloramine and thymol and other solutions showed a statistically significant decline in fluorescence over time. On the

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other hand, the frozen teeth experienced no statistically significant changes through the whole time of the experiment [16,22,39].

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A different composition of sample groups should be taken into consideration when translating the experiences into clinical practice [40]. In our study, we examined premolars and

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molars (including third molars). The differences in morphology of occlusal surfaces of the investigated teeth may be a possible limitation of the present study. In conclusion, the ICDAS II system is an effective method for detecting early carious

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lesions, characterized by a higher sensitivity compared with devices using fluorescence. To improve the diagnostic efficacy of carious lesions on occlusal surfaces, clinicians can combine

Funding

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visual and fluorescence methods, taking into account modifying the cut-off values.

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This work was supported by the Medical University of Bialystok. Grant number:

N/ST/MN/16/001/1170.

Conflict of interests

The authors declare that they have no conflict of interest.

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15

Table 1 Intraclass correlation coefficient (ICC) values for inter- and intra-examiner reproducibility for four methods and 95% confidence intervals in parentheses.

Inter-examiner Method

Intra-examiner

Examinator

ICC

(95% CI)

Examination

ICC

(95% CI)

1

0.77

(0.695-0.824)

1

0.76

(0.691-0.822)

2

0.73

(0.654-0.798)

2

0.88

(0.838-0.910)

DIAGNOdent

1

0.75

(0.574-0.844)

Pen

2

0.78

(0.647-0.858)

1

0.87

(0.823-0.902)

2

0.91

(0.881-0.935)

1

0.83

(0.771-0.872)

2

0.85

(0.799-0.888)

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ICDAS II

(0.767-0.899)

2

0.87

(0.819-0.909)

1

0.83

(0.771-0.872)

2

0.85

(0.799-0.888)

1

0.87

(0.823-0.902)

2

0.91

(0.881-0.935)

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ur

na

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re

CBCT

0.85

-p

VistaCam iX

1

16

Table 2 Cross-tabulation for ICDAS II and DIAGNOdent Pen device with the corresponding CBCT. DIAGNOdent Pen ICDAS II

CBCT

n 0-13 (0)

14-20 (E1)

21-29 (E2)

>29 (D1, D2)

0

1 (E1)

2 (E2)

3 (D1)

4 (D2)

28

26

2

0

0

20

3

5

0

0

1 (E1)

65

40

14

3

8

30

15

14

6

0

2 (E2, D1)

37

5

8

6

18

16

5

10

5

1

3 (D2)

30

4

4

4

18

3

1

13

12

1

Total

160

75

28

13

44

69

ro of

0

42

23

2

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ur

na

lP

re

-p

24

17

Table 3 Cross-tabulation for ICDAS II and VistaCam iX device with the corresponding CBCT.

VistaCam iX ICDAS II

CBCT

n 0-1 (0)

1.1-1.5 (E1)

1.6-2.0 (E2)

2.1-2.5 (D1)

>2.5

0

1 (E1)

2 (E2)

3 (D1)

4 (D2)

(D2) 28

20

8

0

0

0

20

3

5

0

0

1 (E1)

65

17

42

6

0

0

30

15

14

6

0

2 (E2, D1)

37

1

16

20

0

0

16

5

10

5

1

3 (D2)

30

0

8

17

5

0

3

1

13

12

1

Total

160

38

74

43

5

0

69

24

42

23

2

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0

18

Table 4 Sensitivity, specificity, accuracy, positive and negative predictive values of ICDAS II compared with the DIAGNOdent and VistaCam iX at the enamel and dentin thresholds.

Sensitivity

Specificity

Accuracy

PPV

NPV

AUC

Mean (95% CI) Enamel threshold 0.29a

0.64a,b

0.63a

0.71a

0.77a

(0.84-0.95)

(0.20-0.41)

(0.57-0.71)

(0.54-0.71)

(0.53-0.85)

(0.680-0.863)

0.59b

0.55b

0.58a

0.64a

0.51a

0.65a

(0.49-0.69)

(0.43-0.66)

(0.50-0.65)

(0.53-0.73)

(0.40-0.62)

(0.566-0.736)

0.90a

0.41c

0.69b

(0.82-0.95)

(0.30-0.53)

(0.61-0.75)

0.52A

0.87A

VistaCam iX

ICDAS II

0.76a

0.74a

(0.58-0.74)

(0.60-0.87)

(0.660-0.822)

0.43A

0.91A

0.69A

(0.33-0.70)

(0.81-0.92)

(0.75-0.87)

(0.27-0.61)

(0.85-0.95)

(0.616-0.769)

0.48A

0.76B

0.72B

0.27A

0.89A

0.67A

na

DIAGNOdent Pen

0.66a

0.82A

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Dentin threshold

-p

Pen

re

DIAGNOdent

ro of

0.91a

ICDAS II

(0.30-0.67)

(0.68-0.83)

(0.64-0.78)

(0.16-0.42)

(0.82-0.93)

(0.560-0.782)

0.13B

0.97C

0.84A

0.43A

0.86A

0.79A

(0.92-0.99)

(0.77-0.89)

(0.16-0.75)

(0.79-0.91)

(0.694-0.889)

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VistaCam iX

Jo

(0.04-0.31)

a,b,c

The different superscript letters in column are significant differences for the enamel threshold by

McNemar test at p < 0.05 A,B,C

The different superscript letters in column are significant differences for the dentin threshold by

McNemar test at p < 0.05

19

Table 5 The area under the ROC curve, sensitivity and specificity, and corresponding cut-off points for enamel and dentin thresholds according to the manufacturer and highest value of the Youden index. Sensitivity/Specificity

AUC 95% CI (AUC)

p (AUC=0.5)

Mean DIAGNOdent Pen Enamel threshold Cut-off point 0.65

ro of

0.59/0.55 >13*

(0.566-0.736)

Cut-off point 0.46/0.78 >21.13**

Cut-off point 0.48/0.76 0.67

Cut-off point 0.60/0.73

0.0025

(0.660-0.822)

<0.0001

(0.694-0.889)

<0.0001

lP

>24.75**

(0.560-0.782)

re

>29*

-p

Dentin threshold

0.0005

VistaCam iX

Cut-off point

na

Enamel threshold

0.90/0.41

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>1* Cut-off point

0.74

0.77/0.66

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>1.29**

Dentin threshold

Cut-off point

0.13/0.97

>2* 0.79 Cut-off point 0.79/0.77 >1.51**

20

* Cut-off points according to the manufacturer

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na

lP

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-p

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** Cut-off points at highest value of Youden index

21