
==== Front
BMC Oral Health
BMC Oral Health
BMC Oral Health
1472-6831
BioMed Central London

4889
10.1186/s12903-024-04889-0
Research
Evaluation of DIAGNOdent pen for initial occlusal caries diagnosis in permanent teeth
Yehua Du 12
Yiyuan Yang 12
Yihao Liu 12
Jianjun Zhang 3
Shanshan Liang 3
Rourong Chen 12
Han Jiang 12
Baojun Tai 12
Minquan Du 12
Chang Liu liuc0728@whu.edu.cn

12
1 https://ror.org/033vjfk17 grid.49470.3e 0000 0001 2331 6153 Department of Preventive Dentistry, School of Stomatology, Wuhan University, Wuhan, 430079 China
2 https://ror.org/033vjfk17 grid.49470.3e 0000 0001 2331 6153 State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China
3 https://ror.org/0212jcf64 grid.412979.0 0000 0004 1759 225X Department of Preventive Dentistry, Xiangyang Stomatological Hospital, Hubei University of Arts and Science, Xiangyang, 441000 China
19 9 2024
19 9 2024
2024
24 111121 7 2024
10 9 2024
© The Author(s) 2024
2024
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Background

To verify the validity of diagnosing initial caries on occlusal surface of permanent posterior teeth by laser fluorescence instrument DIAGNOdent pen.

Methods

Patients from School of Stomatology in Wuhan University were selected and their posterior teeth were examined using DIAGNOdent pen and the International Caries Detection and Assessment System (ICDAS II) by an experienced dentist. After teeth extraction, histological criteria were used to determine the severity of the lesions. The sensitivity, specificity, accuracy, the area under the curve (AUC), and correlation of DIAGNOdent pen and ICDAS II were analyzed compared with histological criteria. Examiners’ agreement was measured.

Results

The sensitivity range was 0.440-1 while that of specificity was 0.750–0.994. The accuracy and AUC were above 80% and 0.7 respectively. Consistency of examiners’ kappa values of ICDAS II, DIAGNOdent pen, and histological criteria were ranged from 0.629 to 0.840.

Conclusions

ICDAS II and DIAGNOdent pen can be effectively used in tandem or independently for the assessment of initial caries.

Keywords

Initial occlusal caries
Diagnosis
DIAGNOdent pen
ICDAS II
Wuhan University Innovation and entrepreneurship training for students projectW202410486269 Chinese Academy of Stomatology Dental caries prevention and control ability improvement projectCSA-ICP2022-01 issue-copyright-statement© BioMed Central Ltd., part of Springer Nature 2024
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pmcIntroduction

The Fourth National Oral Health Survey in China reported 38.5% of children suffer from caries just after the eruption of permanent teeth, and the number of children suffering from caries increases gradually with age [1]. It was also found that molar teeth are the most caries-prone teeth due to the deep pits and fissures on the occlusal surfaces. Immature permanent teeth are prone to developing deep pits and fissures. Although the occlusal surfaces constitute only 15% of the total tooth surface area, they are responsible for a disproportionate 50% of carious lesions in the 18-year-old population [2]. In China, the results of the Third National Oral Health Survey conducted in 2005 showed that occlusal caries accounted for more than 90% of the caries in children aged 12 years old. Therefore, caries management on the occlusal surfaces remains a major challenge for dentist.

According to the expert consensus of workshop of ORCA and the IADR Cariology Research [3], the dynamic process of caries development consisted of health enamel, non-cavitated lesion and cavitated lesion. Non-cavitated caries is also known as initial caries lesion. If proper intervention is taken before cavity formation, subsequent progression can be avoided or even reversed. Moreover, the measures to treat non-cavitated lesion and cavitated lesion are different. Therefore, for avoiding both over treatment and undertreatment, it is important to determine whether caries is non-cavitated or cavitated.

However, in the clinic, it is not easy for dentists to determine the non-cavitated caries. The most common method of examination is clinical visualization. Compared with the WHO criteria previously used, the International Caries Detection and Assessment System (ICDAS II) is now widely recommended for determining non-cavitated and cavitated lesions because the ICDAS II describes early caries more meticulous than the WHO criteria. ICDAS II scores of 1 and 2 have been clearly identified as non-cavitated (initial caries), but ICDAS II score of 3 is difficult to be determined [4, 5]. The ICDAS II score of 3 is defined as localized enamel disintegration and surface discontinuity without dentin exposure when the tooth surface is wet. Nevertheless, this criterion remains subjective to the examiner and often exceeds the capabilities of many dentists, regardless of extensive training. Consequently, diagnostic outcomes can still be unstable and lack consistency.

Therefore, many instruments for caries diagnosis have sprung up in recent years [6]. Among them, the laser fluorescent caries detector pen, DIAGNOdent pen, is used to provide results easily and objectively with less expense. Studies demonstrated it was more accurate in diagnosis of the smooth surface caries [7–9], while there were different opinions about its applications in diagnosis of the fissure caries [10, 11]. In addition, there were few in vivo examination results, and most of the current studies were basically in vitro studies that did not consider the influence of the clinical environment on the diagnostic results [12, 13]. Therefore, it had not yet been widely used in clinic.

This study assesses the DIAGNOdent pen’s consistency, correlation, and validity compared to visual ICDAS II inspections for detecting non-cavitated fissure caries on permanent molars, using histological criteria. The null hypothesis was that DIAGNOdent pen had no statistical significance in diagnosis for early dental caries.

Materials and methods

This study was approved by the Ethics Committee of Wuhan University Stomatological Hospital under the number 2022E03. Participants received information about the purpose and procedures and signed an informed consent statement agreeing to participate in the study and to donate teeth for use in this study after extraction. These teeth were extracted for periodontal, orthodontic, and surgical reasons.

Sample selection

From August 1 to December 31, 2022, 160 eligible volunteers (age range 16–40 years old, able to cooperate with the operation without systematic diseases) were recruited from patients scheduled for tooth extraction at Stomatology hospital of Wuhan University to participate in the study. The occlusal surfaces of erupted or partially erupted molars, which were freely available for examination, were selected according to the following inclusion criteria: absence of restorations or sealants on the occlusal surfaces; absence of extensive carious lesion surfaces on the smooth surfaces; and absence of dysplasia and fluorosis, without visually distinct cavity. Occlusal caries were diagnosed by visual examination using ICDAS II criteria and by DIAGNOdent pen, respectively. Then they were extracted by an experienced surgeon. From the published literatures, the sensitivity and specificity were varied from 0.17 to 0.9, therefore, we used the maximum \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$P$$\end{document} 0.5, tolerance error \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\delta\:}$$\end{document}0.1, \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$Z_{1-\alpha/2}$$\end{document} 1.96, to calculate the sample size according to the equation, a minimum sample of 96 teeth was determined. Twenty teeth were added to compensate for cutting failure. The objective of the present study is initial caries, so 120 teeth with initial caries diagnosed by visual examination using ICDAS II criteria or by DIAGNOdent pen were guaranteed. Finally 175 posterior teeth (48 premolars) were involved.

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Pilot-experiment to determine the DIAGNOdent pen interval range

According to the studies analyzed in Heinrich-Weltzien’s literature [14], the ranges of DIAGNOdent pen intervals were concluded and limited to 0 (0–15), 1 (6–21), 2 (15–37). Then 20 teeth were randomly selected, and they were histologically examined. The DIAGNOdent pen interval range was further determined according to the results of the clinical examination and histological results.

Visual clinical examination with ICDAS II and laser fluorescence inspection in vivo

The reference examiner (L.C) diagnosed the initial caries lesion on the occlusal surfaces in vivo. The teeth were brushed and rinsed with pumice and water paste. After isolation with cotton rolls, visual examination was performed under a dental operatory light and codes were recorded using ICDAS II criteria. The ICDAS II severity criteria were: the site with the most severe lesion was selected. 0 no change or slight change in enamel translucency after prolonged air-drying for 5 s; 1 first visual change in enamel (visible only after prolonged air-drying or limited to the extent of pits or fissures); 2 significant visual change in enamel; and 3 fracture of enamel opacity or discoloration of enamel in a localized enamel rupture (with no visual signs of dentin involvement).

After visual inspection, laser fluorescence was performed by using a DIAGNOdent pen 2095 (Kavo, Biberach, Germany). The teeth were dried, the device was calibrated according to the manufacturer’s instructions, zeroed on the normal tooth surface, then moved over the pits and fissures, recorded the peaks, and the mean of three values was taken to determine the final value. Classification was determined based on the pilot-experimental results, modifying the different cut-off points suggested by the manufacturer: (i) 0–8: no demineralization-sound; (ii) 9–18: outer 1/2 demineralization of enamel; (iii) 19–28: inner 1/2 demineralization of enamel; and (iv) > 28: dentin demineralization.

Histological verification ex-vivo

After extraction, teeth were scrapped the teeth debris and brushed for pumice and water, then sectioned using a mounted precision cutter (Isomet; Buhler, Lake Bluff, IL, USA). Sections of each tooth were evaluated under a 20x magnification stereomicroscope (Carl Zeiss, Oberkochen, Germany) by examiner (Z.JJ) who was unaware of the results from the ICDAS II and DIAGNOdent pen. Caries lesions were defined according to the extent of white or brown areas of demineralization in the direction of the cementum and classified according to the criterion established by Downer et al. [15]: 0: no demineralization; 1: demineralization limited to the outer 1/2 thickness of enamel; 2: demineralization limited to the inner 1/2 of enamel; 3: demineralization of the outer 1/2 of dentin; 4: demineralization of the inner 1/2 of dentin.

Determination of sensitivity, specificity, accuracy, the area under the curve (AUC) and correlation for the ICDAS II and DIAGNOdent pen

Sensitivity, specificity, accuracy, AUC were determined at different threshold D1, D2, D3 which were used to distinguish noncavitated caries and cavitated caries. The receiver operating characteristic (ROC) curve is plotted with sensitivity on the vertical axis, illustrating the diagnostic test’s ability to correctly identify positive cases. The horizontal axis is marked by 1-specificity, which represents the rate of false positives, showing how often the test incorrectly diagnoses negative cases as positive. To assess how well ICDAS II and DIAGNOdent pen in identifying carious lesions when compared to the gold standard, the correlations between ICDAS II and histological criteria, between DIAGNOdent pen and histological criteria, as well as between ICDAS II and DIAGNOdent pen were analyzed.

Determine the Kappa value of the examiners

Reference examiner was L.C., examiner1 was Z.JJ. and examiner2 was L.SS. 15–20 (teeth number = 60) subjects were randomly recruited for diagnosis by visual examination using ICDAS II and by DIAGNOdent pen, respectively, 15–20 extracted teeth were randomly selected for histological examination. Following the recommendations of the ICDAS II manual standards, the examiners (Z.JJ, L.SS) underwent a training process and discussed the criteria with the reference examiner (L.C). The examiners and reference examiner then assessed these teeth individually.

Statistical analysis

The statistical analysis for this study was conducted using the software package SPSS 20 for Windows (Chicago, IL, USA). Interval ranges for the DIAGNOdent pen measurements were ascertained through descriptive analysis. Histological evaluation served as the reference standard for comparative analysis. Data obtained from three distinct criteria were amalgamated to calculate the sensitivity, specificity, accuracy and AUC of both ICDAS II and DIAGNOdent pen. Additionally, the diagnostic efficacy of these tools was further evaluated using the ROC curve analysis and the ROC curve graphs were drawn by SPSS software. To quantify the association between the continuous variable of DIAGNOdent pen readings and the categorical scale of ICDAS II scores in relation to the histological standard, we employed Spearman’s rank correlation coefficient. Furthermore, the level of agreement between the two diagnostic tools was assessed using the Kappa statistic, with calculations performed using the chi-square test.

Results

Pilot-experiment to determine the DIAGNOdent pen interval range

ICDAS (clinical) upper and lower limits 0–10 (Confidence interval CI3-7), 8–18 (CI12-14), 16–26 (CI20-22); His-Downer: 0–5 (CI0-5), 9–18 (CI11-16), 16–28 (CI20-25). Taken together, using the histology gold standard, the range of intervals for DIAGNOdent pen was determined to be 0 (0–8), 1 (9–18), 2 (19–28), > 2 (> 28).

Comparison of histological results with ICDAS II and DIAGNOdent pen

The histological results revealed that eighteen teeth (10.3%) were healthy (score 0) and 113 teeth (64.6%) had a caries lesion in the enamel (score1 and 2). Seventy-one teeth were diagnosed with early caries by both ICDAS II and histological criteria, while fifty-seven teeth were diagnosed with early caries by both DIAGNOdent pen and histological criteria (Table 1).

Table 1 Comparison of histological results with ICDAS II and DIAGNOdent pen

Variable	Histological gold standard	
0	1	2	3	4	Total	
ICDAS code		
 0	8	1	0	0	0	9	
 1	8	34	17	1	0	60	
 2	2	11	37	8	2	60	
 3	0	1	11	16	6	34	
 4	0	0	1	4	7	12	
 Total	18	47	66	29	15	175	
Cut-off point for DIAGNOdent pen	
 0–8	18	19	4	0	0	41	
 9–18	0	23	20	2	1	46	
 19–28	0	5	34	4	1	44	
 > 28	0	0	8	23	13	44	
 Total	18	47	66	29	15	175	

Sensitivity, specificity, accuracy, and AUC for the ICDAS II and DIAGNOdent pen

The cut-off points from Table 1 were categorized based on the criteria by the Table 2 threshold. Sensitivity, specificity, accuracy, and AUC of both ICDAS II severity criteria and DIAGNOdent pen cut-off points were calculated according to the formulas. The results were shown in Table 3. The ROC curves of each threshold were displayed in Fig. 1. They indicated that DIAGNOdent pen, even better than ICDAS II, had statistically significant diagnostic efficacy for early dental caries.

Table 2 The diagnosis threshold criteria of histology, ICDAS II, and DIAGNOdent pen

Threshold	Histology
non-/cavitated	ICDAS
non-/cavitated	DIAGNOdent pen
non-/cavitated	
D1	0/>0	0/>0	0–8/>8	
D2	0–1/>1	0–1/>1	0–18/>18	
D3	0–2/>2	0–2/>2	0–28/>28	

Table 3 Sensitivity, specificity, accuracy, and AUC of ICDAS II and DIAGNOdent Pen cut-off points

Diagnosis method	Sensitivity	Specificity	Accuracy	AUC(95%CI)	
D1		
ICDAS II	0.440	0.994	93.71%	0.719 (0.565–0.873)

P = 0.002

	
DIAGNOdent pen	1	0.854	86.86%	0.927(0.888–0.965)

P = 0.000

	
D2		
ICDAS II	0.785	0.836	81.71%	0.811 (0.740–0.881)

P = 0.000

	
DIAGNOdent pen	0.923	0.755	81.71%	0.839 (0.777-0.900)

P = 0.000

	
D3		
ICDAS II	0.901	0.750	86.29%	0.825 (0.744–0.907)

P = 0.000

	
DIAGNOdent pen	0.939	0.818	90.86%	0.879 (0.807–0.950)

P = 0.000

	

Fig. 1 ROC curve of ICDAS II and DIAGNOdent pen cut-off points with histological criteria as the reference

Correlation of the three diagnosis methods

The Spearman’s rank correlation coefficient was utilized to evaluate the association between the diagnostic reliability scores of the three methods. For the overall cases, a significant positive correlation was observed between the ICDAS II and the histological criteria, as well as between the DIAGNOdent pen and the histological criteria, and also between the ICDAS II and the DIAGNOdent pen. The respective correlation coefficients were 0.749, 0.810, and 0.728, demonstrating a robust positive relationship among the methods. When focusing on initial caries, a significant positive correlation persisted between ICDAS II and histological criteria, and similarly between the DIAGNOdent pen and histological criteria, along with a correlation between ICDAS II and the DIAGNOdent pen. The correlation coefficients for these comparisons were 0.493, 0.383, and 0.355, respectively.

Determine the Kappa value of the examiners

The Kappa values of the examiners were between 0.6 and 0.8, demonstrating there were statistically significant consistency among them. The results were displayed in Table 4.

Table 4 Examiners’ kappa

	Examiner1
kappa (weighted kappa)	95%CI	Examiner2
kappa(weighted kappa)	95%CI	
ICDAS II	0.834 (0.85)	0.701–0.967

P = 0.000

	0.822 (0.84)	0.691–0.953

P = 0.000

	
DIAGNOdent	0.741 (0.81)	0.535–0.947

P = 0.000

	0.629 (0.70)	0.410–0.849

P = 0.000

	
His-Downer	0.818 (0.84)	0.514–1.122

P = 0.003

	0.796 (0.84)	0.443–1.149

P = 0.003

	

Discussion

The chosen cut-off values for the DIAGNOdent pen exhibited variability across studies, which could be due to different detection methods or variations among DIAGNOdent pen devices. It was necessary to reassess the standard cut-off values provided by the manufacturer, as it may not apply to every DIAGNOdent pen [14]. A study by Li et al. detected occlusal caries in deciduous teeth using DIAGNOdent, and found that the cut-off values provided by the manufacturer were not entirely consistent, which indicated that they needed to be evaluated under specific conditions [16]. Similarly, in a research assessing root caries lesions by DIAGNOdent, Mitchell et al. also observed that the optimal cut-off values might vary among different surfaces, indicating the need for cut-off values reassessment [17]. Marczuk-Kolada et al. advised to adjust the cut-off values suggested by the manufacturers to improve the diagnostic prowess of the DIAGNOdent pen [18]. Therefore, in the present study, focusing on occlusal caries in permanent teeth, the cut-off values were determined by preliminary study to ensure they were appropriate for our specific investigation.

There are several histological diagnosis criteria [19–22]. Among these, Ekstrand KR’s criteria is more extensively used [23, 24]. The values are divided as follows: caries free (0), caries extending up to the outer 1/2 of enamel (1), caries extending into the inner half of enamel and the outer 1/3 of dentine (2), caries in middle 1/3 of dentine (3), and caries in inner 1/3 of dentine (4). Achilleos et al. modified Ekstrand KR’s criteria and combined caries extending up to halfway through the enamel (E), caries extending into the inner 1/2 of enamel and the outer 1/3 of dentine (D1) [25]. Another predominate criterion Downer’s histological criteria is different from them [15]. The enamel caries is divided into outer 1/2 of enamel caries (1) and inner 1/2 of enamel caries, up to the enamel-dentine junction (2) [26–28]. However, researchers can choose the appropriate criteria based on the purpose and subjects of the experiment. The present study is specifically focused on incipient caries, thus for this purpose, in order to avoid the mixing of intra-enamel 1/2 and extra-essential 1/3 in Ekstrand’s criteria, we employed the Downer’s criteria. This approach offered significant advantages in the early caries’ research, enabling us to accurately identify and analyze the characteristics of incipient caries.

Sensitivity reflects the method’s ability to identify real lesions, while specificity reflects the its ability to avoid misdiagnosis. DIAGNOdent pen showed high sensitivity at all thresholds, especially D3, suggesting a potential advantage in detecting initial caries. The specificity of DIAGNOdent pen gradually increased and even exceeded ICDAS II, signifying its enhanced dependability in excluding non-cavitation. As evident from Minuesa-García et al. [29], including ours, the DIAGNOdent system exhibited a sensitivity that was superior to that achieved through the ICDAS II. However, in terms of specificity, the DIAGNOdent system exhibited a marginally lower rate compared to ICDAS II. A noteworthy point is that the integration of these systems can yield sensitivity and specificity levels that are comparable or even exceed those achieved by the individual methods.

Mitchell et al. also reported that DIAGNOdent’s sensitivity, specificity, and accuracy rates all surpassed 75% [17], which was in line with our findings. On facial smooth surfaces, Shaalan et al. also found the overall performance of DIAGNOdent was equivalent to the visual examination using ICDAS II. They concluded DIAGNOdent might be considered a useful adjunctive device for detection and monitoring development of noncavitated lesions [30]. To assess the diagnostic efficacy and reliability, AUC was calculated for both ICDAS II and DIAGNOdent pen. From the data, it could be seen that DIAGNOdent pen had higher AUC values at all thresholds, especially at the D3 threshold, which showed extremely high diagnostic performance. The findings were consistent with those reported in previous studies [31–34].

However, there were several different opinions. Marczuk-Kolada et al. found when considering the enamel threshold, visual examination using ICDAS II criteria exhibited significantly superior sensitivity and accuracy compared to the DIAGNOdent pen. Conversely, the DIAGNOdent pen displayed notably higher specificity values for the enamel threshold [18]. Achilleos et al. demonstrated the sensitivity and specificity of DIAGNOdent pen were 0.61 and 0.51 respectively [35]. In their studies, they adopted ICDAS II as a gold standard criterion considering its correlation with histological criteria. However, ICDAS criteria can’t substitute the histological criteria, even if there were correlations between them.

There were strong correlations among ICDAS II, DIAGNOdent pen and histological criterion. When diagnosing initial caries, there were moderate correlations among them. In other studies, compared with histological scores, correlation coefficients of DIAGNOdent were ranged from 0.47 to 0.738 [9, 11, 36]. Therefore, as ICDAS II, DIAGNOdent pen was also a suitable and reliable instrument for the diagnosis of dental caries, including its earliest phases.

ICDAS II criteria mainly depended on visual examination, with a large degree of subjectivity and experience of the examiner. In contrast, the DIAGNOdent devise was designed to offer a more objective evaluation, being relatively easier for examiners to master. However, from the kappa values, DIAGNOdent demonstrated acceptable reliability but fell short of the consistency observed with ICDAS II and histology assessments. This might be due to the high sensitivity of DIAGNOdent pen, which could lead to fluctuating values. This suggested that using DIAGNOdent pen required a rigorous and consistent discipline to ensure accurate diagnostic outcomes.

A potential limitation of this study is its exclusive focus on the characteristics of the DIAGNOdent pen when applied to teeth. To address this, comprehensive clinical studies are essential, even though such research on the application of diagnostic methods to track the efficacy of subsequent treatments is rarely found in existing literature. These studies should validate the diagnostic efficacy of the DIAGNOdent pen via longitudinal trials, offering robust clinical evidence to support its future use. Additionally, they should establish objective criteria for evaluating non-cavitated fissure caries, thereby improving the quality of diagnostic evidence and guaranteeing the effectiveness of treatment. Other possible limitations could be the variations in the morphology of the occlusal surfaces of the teeth studied. In our research, we focused on the examination of premolars and molars, including the third molars. When applying the findings to clinical practice, it’s crucial to consider the distinct compositions of the sample groups [37].

Conclusion

In the present study, the results showed the DIAGNOdent pen possessed comparable sensitivity, specificity, accuracy and AUC to ICDAS II. With a thorough understanding and mastery of the application techniques, a definitive diagnosis can be established through either the visual examination criteria of ICDAS II or by using the DIAGNOdent pen independently. In instances, However, when ICDAS II cannot provide a conclusive diagnosis, employing the DIAGNOdent pen in tandem can be an effective conjunction. Future studies can consider expanding the sample size to further validate these findings and explore the application of different detection methods in various clinical situations.

Acknowledgements

Not applicable.

Author contributions

Du Yehua, Yang Yiyuan, Liu Yihao: photograph under microscope, data input, statistical analysis, manuscript revise; Zhang Jianjun: histological assessment and kappa determination, Liang Shanshan: histological assessment, Chen Rourong: teeth longitudinal section; Jiang Han, Du Minquan, Tai Baojun: study design and supervision; Liu Chang: writing, review, editing, project administration.

Funding

Chinese Academy of Stomatology Dental caries prevention and control ability improvement project (CSA-ICP2022-01), Wuhan University Innovation and entrepreneurship training for students project (W202410486269).

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Declarations

Ethics approval and consent to participate

The experimental protocol was established, according to the ethical guidelines of the Helsinki Declaration and was approved by the Human Ethics Committee of Stomatology School of Wuhan University (2022E03). Written informed consent was obtained from participants.

Consent for publication

Not applicable.

Clinical trial number

Not applicable.

Competing interests

The authors declare no competing interests.

Abbreviations

ICDAS International Caries Detection and Assessment System

DDP DIAGNOdent pen

AUC Area under the receiver operating characteristic curve

ROC Receiver operating characteristic

CI Confidence interval

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Du Yehua, Yang Yiyuan and Liu Yihao are coauthors who are contributed equally.
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References

1. Gu ZW, Zhang SS, Zhang RJ, Tang H, Sun XY, Liu XN, Zheng SG. Prevalence of caries in Mainland China: evidence from 1980 to 2018: a systematic review and meta-analysis. Chin J Dent Res. 2019;22(4):251–263. 10.3290/j.cjdr.a43736. PMID: 31859285.
2. Carvalho JC Dige I Machiulskiene V Qvist V Bakhshandeh A Fatturi-Parolo C Maltz M Occlusal caries: biological approach for its diagnosis and management Caries Res 2016 50 6 527 42 10.1159/000448662 27658123
Carvalho JC, Dige I, Machiulskiene V, Qvist V, Bakhshandeh A, Fatturi-Parolo C, Maltz M. Occlusal caries: biological approach for its diagnosis and management. Caries Res. 2016;50(6):527–42. 10.1159/000448662. Epub 2016 Sep 23. PMID: 27658123.27658123
3. Machiulskiene V Campus G Carvalho JC Dige I Ekstrand KR Jablonski-Momeni A Maltz M Manton DJ Martignon S Martinez-Mier EA Pitts NB Schulte AG Splieth CH Tenuta LMA Ferreira Zandona A Nyvad B Terminology of dental caries and dental caries management: consensus report of a workshop organized by ORCA and cariology research group of IADR Caries Res 2020 54 1 7 14 10.1159/000503309 31590168
Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of dental caries and dental caries management: consensus report of a workshop organized by ORCA and cariology research group of IADR. Caries Res. 2020;54(1):7–14. 10.1159/000503309. Epub 2019 Oct 7. PMID: 31590168.31590168
4. Frencken JE, Giacaman RA, Leal SC. An assessment of three contemporary dental caries epidemiological instruments: a critical review. Br Dent J. 2020;228(1):25-31. 10.1038/s41415-019-1081-1. PMID: 31925370.
5. Butera A Maiorani C Morandini A Simonini M Morittu S Trombini J Scribante A Evaluation of children caries risk factors: a narrative review of nutritional aspects, oral Hygiene habits, and bacterial alterations Child (Basel) 2022 9 2 262 10.3390/children9020262
Butera A, Maiorani C, Morandini A, Simonini M, Morittu S, Trombini J, Scribante A. Evaluation of children caries risk factors: a narrative review of nutritional aspects, oral Hygiene habits, and bacterial alterations. Child (Basel). 2022;9(2):262. 10.3390/children9020262. PMID: 35204983; PMCID: PMC8870668.
6. Mazur M, Jedlinski M, Vozza I, Pasqualotto D, Nardi GM, Ottolenghi L, Guerra F. Correlation between Vista Cam, ICDAS-II, X-ray bitewings and cavity extent after lesion excavation: an in-vivo pilot study. Minerva Stomatol. 2020;69(6):343-348. 10.23736/S0026-4970.20.04341-1. Epub 2020 Apr 10. PMID: 32278341.
7. Bahramian H Argani P Baghalian A Comparison of different diagnostic techniques in detecting smooth surface caries in primary molars using the histological gold standard: an in vitro study Photodiagnosis Photodyn Ther 2020 31 101867 10.1016/j.pdpdt.2020.101867 32526375
Bahramian H, Argani P, Baghalian A. Comparison of different diagnostic techniques in detecting smooth surface caries in primary molars using the histological gold standard: an in vitro study. Photodiagnosis Photodyn Ther. 2020;31:101867. 10.1016/j.pdpdt.2020.101867. Epub 2020 Jun 8. PMID: 32526375.32526375
8. Novaes TF Moriyama CM De Benedetto MS Kohara EK Braga MM Mendes FM Performance of fluorescence-based methods for detecting and quantifying smooth-surface caries lesions in primary teeth: an in vitro study Int J Paediatr Dent 2016 26 1 13 9 10.1111/ipd.12152 25614929
Novaes TF, Moriyama CM, De Benedetto MS, Kohara EK, Braga MM, Mendes FM. Performance of fluorescence-based methods for detecting and quantifying smooth-surface caries lesions in primary teeth: an in vitro study. Int J Paediatr Dent. 2016;26(1):13–9. 10.1111/ipd.12152. Epub 2015 Jan 23. PMID: 25614929.25614929
9. Aljehani A, Yang L, Shi XQ. In vitro quantification of smooth surface caries with DIAGNOdent and the DIAGNOdent pen. Acta Odontol Scand. 2007;65(1):60-3. 10.1080/00016350601058051. PMID: 17354096.
10. Perdiou A Fratila AD Sava-Rosianu R Alexa VT Lalescu D Jumanca D Galuscan A In vivo performance of visual criteria, laser-induced fluorescence, and light-induced fluorescence for early caries detection Diagnostics (Basel) 2023 13 20 3170 10.3390/diagnostics13203170 37891991
Perdiou A, Fratila AD, Sava-Rosianu R, Alexa VT, Lalescu D, Jumanca D, Galuscan A. In vivo performance of visual criteria, laser-induced fluorescence, and light-induced fluorescence for early caries detection. Diagnostics (Basel). 2023;13(20):3170. 10.3390/diagnostics13203170. PMID: 37891991; PMCID: PMC10606100.37891991
11. Rashid MF Karobari MI Halim MS Noorani TY Effectiveness of visual-tactile examination and DIAGNOdent pen in detecting early enamel caries and its remineralisation: an in vitro study Biomed Res Int 2022 2022 1263750 10.1155/2022/1263750 35059458
Rashid MF, Karobari MI, Halim MS, Noorani TY. Effectiveness of visual-tactile examination and DIAGNOdent pen in detecting early enamel caries and its remineralisation: an in vitro study. Biomed Res Int. 2022;2022:1263750. 10.1155/2022/1263750. PMID: 35059458; PMCID: PMC8766177.35059458
12. Caceda JH Jiang S Calderon V Villavicencio-Caparo E Sensitivity and specificity of the ICDAS II system and bitewing radiographs for detecting occlusal caries using the Spectra™ caries detection system as the reference test in children BMC Oral Health 2023 23 1 896 10.1186/s12903-023-03615-6 37986066
Caceda JH, Jiang S, Calderon V, Villavicencio-Caparo E. Sensitivity and specificity of the ICDAS II system and bitewing radiographs for detecting occlusal caries using the Spectra™ caries detection system as the reference test in children. BMC Oral Health. 2023;23(1):896. 10.1186/s12903-023-03615-6. PMID: 37986066; PMCID: PMC10662650.37986066
13. Mazur M Jedliński M Ndokaj A Corridore D Maruotti A Ottolenghi L Guerra F Diagnostic drama. Use of ICDAS II and fluorescence-based Intraoral Camera in Early Occlusal Caries detection: a clinical study Int J Environ Res Public Health 2020 17 8 2937 10.3390/ijerph17082937 32344544
Mazur M, Jedliński M, Ndokaj A, Corridore D, Maruotti A, Ottolenghi L, Guerra F. Diagnostic drama. Use of ICDAS II and fluorescence-based Intraoral Camera in Early Occlusal Caries detection: a clinical study. Int J Environ Res Public Health. 2020;17(8):2937. 10.3390/ijerph17082937. PMID: 32344544; PMCID: PMC7215869.32344544
14. Heinrich-Weltzien R Kühnisch J Oehme T Comparison of different DIAGNOdent pen cut-off limits for in vivo detection of occlusal caries Oper Dent 2003 28 6 672 80 14653279
Heinrich-Weltzien R, Kühnisch J, Oehme T, et al. Comparison of different DIAGNOdent pen cut-off limits for in vivo detection of occlusal caries. Oper Dent. 2003;28(6):672–80. PMID: 14653279.14653279
15. Downer MC. Concurrent validity of an epidemiological diagnostic system for caries with the histological appearance of extracted teeth as validating criterion. Caries Res. 1975;9(3): 231–46. 10.1159/000260160. PMID: 1090371.
16. Li X, Fan X, Jia S, et al. Clinical study on the diagnosis of occlusal caries in deciduous teeth using laser fluorescence detector. West China J Stomatol. 2006;24(01):36–8.
17. Mitchell C Zaku H Milgrom P Mancl L Prince DB The accuracy of laser fluorescence (DIAGNOdent) in assessing caries lesion activity on root surfaces, around crown margins, and in furcations in older adults BDJ Open 2021 7 14 10.1038/s41405-021-00069-2 33758162
Mitchell C, Zaku H, Milgrom P, Mancl L, Prince DB. The accuracy of laser fluorescence (DIAGNOdent) in assessing caries lesion activity on root surfaces, around crown margins, and in furcations in older adults. BDJ Open. 2021;7:14. 10.1038/s41405-021-00069-2.33758162
18. Marczuk-Kolada G Luczaj-Cepowicz E Obidzinska M Rozycki J Performance of ICDAS II and fluorescence methods on detection of occlusal caries-An ex vivo study Photodiagnosis Photodyn Ther 2020 29 101609 10.1016/j.pdpdt.2019.101609 31778796
Marczuk-Kolada G, Luczaj-Cepowicz E, Obidzinska M, Rozycki J. Performance of ICDAS II and fluorescence methods on detection of occlusal caries-An ex vivo study. Photodiagnosis Photodyn Ther. 2020;29:101609. 10.1016/j.pdpdt.2019.101609. Epub 2019 Nov 26. PMID: 31778796.31778796
19. Rekha GS Chandrasekhar R Vinay C Uloopi KS RojaRamya KS Chaitanya P In vitro evaluation of reliability and validity of International Caries Detection and Assessment System II coding for occlusal caries using magnification Int J Clin Pediatr Dent 2023 16 Suppl 2 138 41 10.5005/jp-journals-10005-2584 38078031
Rekha GS, Chandrasekhar R, Vinay C, Uloopi KS, RojaRamya KS, Chaitanya P. In vitro evaluation of reliability and validity of International Caries Detection and Assessment System II coding for occlusal caries using magnification. Int J Clin Pediatr Dent. 2023;16(Suppl 2):138–41. 10.5005/jp-journals-10005-2584. PMID: 38078031; PMCID: PMC10701173.38078031
20. Ünal M Koçkanat A Güler S Gültürk E Diagnostic performance of different methods in detecting incipient non-cavitated occlusal caries lesions in permanent teeth J Clin Pediatr Dent 2019 43 3 173 9 10.17796/1053-4625-43.3.5 30964722
Ünal M, Koçkanat A, Güler S, Gültürk E. Diagnostic performance of different methods in detecting incipient non-cavitated occlusal caries lesions in permanent teeth. J Clin Pediatr Dent. 2019;43(3):173–9. 10.17796/1053-4625-43.3.5. Epub 2019 Apr 9. PMID: 30964722.30964722
21. Sarti CS de Oliveira RS de Campos PH Novaes TF Diniz MB Rodrigues JA Influence of examiners’ experience on the reproducibility of different gold standard techniques and histological criteria for validation of the diagnosis of occlusal caries lesions Histol Histopathol 2019 34 4 353 8 10.14670/HH-18-047 30251744
Sarti CS, de Oliveira RS, de Campos PH, Novaes TF, Diniz MB, Rodrigues JA. Influence of examiners’ experience on the reproducibility of different gold standard techniques and histological criteria for validation of the diagnosis of occlusal caries lesions. Histol Histopathol. 2019;34(4):353–8. 10.14670/HH-18-047. Epub 2018 Sep 25. PMID: 30251744.30251744
22. Kockanat A, Unal M. In vivo and in vitro comparison of ICDAS II, DIAGNOdent pen, CarieScan PRO and SoproLife camera for occlusal caries detection in primary molar teeth. Eur J Paediatr Dent. 2017;18(2):99-104. 10.23804/ejpd.2017.18.02.03. PMID: 28598179.
23. Ekstrand KR, Rickets DN, Kidd EA. Reproducibility and accuracy of three methods for assessment of demineralization depth of the occlusal surface: an in vitro examination. Caries Res. 1997;31:224-231. 10.1159/000262404. PMID: 9165195.
24. Michou S, Lambach MS, Ntovas P, Benetti AR, Bakhshandeh A, Rahiotis C, Ekstrand KR, Vannahme C. Automated caries detection in vivo using a 3D intraoral scanner. Sci Rep. 2021;11(1):21276. doi: 10.1038/s41598-021-00259-w. Erratum in: Sci Rep. 2021;11(1):23951. 10.1038/s41598-021-01926-8. Erratum in: Sci Rep. 2022;12(1):13240. doi: 10.1038/s41598-022-17576-3. PMID: 34711853; PMCID: PMC8553860.
25. Achilleos EE, Rahiotis C, Kakaboura A, Vougiouklakis G. Evaluation of a new fluorescence-based device in the detection of incipient occlusal caries lesions. Lasers Med Sci. 2013;28(1):193-201. 10.1007/s10103-012-1111-6. Epub 2012 May 11. PMID: 22576667.
26. Tassoker M Ozcan S Karabekiroglu S Occlusal caries detection and diagnosis using visual ICDAS criteria, laser fluorescence measurements, and near-infrared light transillumination images Med Princ Pract 2020 29 1 25 31 10.1159/000501257 31158839
Tassoker M, Ozcan S, Karabekiroglu S. Occlusal caries detection and diagnosis using visual ICDAS criteria, laser fluorescence measurements, and near-infrared light transillumination images. Med Princ Pract. 2020;29(1):25–31. 10.1159/000501257. Epub 2019 Jun 4. PMID: 31158839; PMCID: PMC7024861.31158839
27. Seremidi K Lagouvardos P Kavvadia K Comparative in vitro validation of VistaProof and DIAGNOdent Pen for occlusal caries detection in permanent teeth Oper Dent 2012 37 3 234 45 10.2341/10-326-L 22166109
Seremidi K, Lagouvardos P, Kavvadia K. Comparative in vitro validation of VistaProof and DIAGNOdent Pen for occlusal caries detection in permanent teeth. Oper Dent. 2012;37(3):234–45. 10.2341/10-326-L. Epub 2011 Dec 14. PMID: 22166109.22166109
28. Ari T Ari N The performance of ICDAS-II using low-powered magnification with light-emitting diode headlight and alternating current impedance spectroscopy device for detection of occlusal caries on primary molars ISRN Dent 2013 2013 276070 10.1155/2013/276070 23956865
Ari T, Ari N. The performance of ICDAS-II using low-powered magnification with light-emitting diode headlight and alternating current impedance spectroscopy device for detection of occlusal caries on primary molars. ISRN Dent. 2013;2013:276070. 10.1155/2013/276070. PMID: 23956865; PMCID: PMC3728523.23956865
29. Minuesa-García E Iranzo-Cortés JE Almerich-Torres T Bellot-Arcís C Montiel-Company JM Almerich-Silla JM Diagnostic validity in occlusal caries detection of ICDAS II, DIAGNOdent, radiography and a combination of the three methods: an in vitro study J Clin Med 2022 11 10 2937 10.3390/jcm11102937 35629063
Minuesa-García E, Iranzo-Cortés JE, Almerich-Torres T, Bellot-Arcís C, Montiel-Company JM, Almerich-Silla JM. Diagnostic validity in occlusal caries detection of ICDAS II, DIAGNOdent, radiography and a combination of the three methods: an in vitro study. J Clin Med. 2022;11(10):2937. 10.3390/jcm11102937. PMID: 35629063; PMCID: PMC9146251.35629063
30. Shaalan OO DIAGNOdent versus international Caries Detection and Assessment System in detection of incipient carious lesions: a diagnostic accuracy study J Conserv Dent 2023 26 2 199 206 10.4103/jcd.jcd_575_22 37205891
Shaalan OO. DIAGNOdent versus international Caries Detection and Assessment System in detection of incipient carious lesions: a diagnostic accuracy study. J Conserv Dent. 2023;26(2):199–206. 10.4103/jcd.jcd_575_22. Epub 2023 Mar 16. PMID: 37205891; PMCID: PMC10190091.37205891
31. Rodrigues JA Hug I Diniz MB Lussi A Performance of fluorescence methods, radiographic examination and ICDAS II on occlusal surfaces in vitro Caries Res 2008 42 297 304 10.1159/000148162 18663299
Rodrigues JA, Hug I, Diniz MB, Lussi A. Performance of fluorescence methods, radiographic examination and ICDAS II on occlusal surfaces in vitro. Caries Res. 2008;42:297–304. 10.1159/000148162. Epub 2008 Jul 29. PMID: 18663299.18663299
32. Diniz MB, Santos-Pinto L, Boldieri T, Cordeiro RCL, Lussi A, Rodrigues JA. The performance of conventional and fluorescence-based methods for occlusal caries detection An in vivo study with histological validation. J Am Dent Assoc. 2012;143, 339-350. 10.14219/jada.archive.2012.0176. PMID: 22467694.
33. Oancea R, Podariu AC, Vasile L, Sava-Ro sianu R, Folescu R. In vitro evaluation of laser fluorescence devices for caries detection through stereomicroscopic imaging. Rom J Morphol Embryol. 2013; 54, 333-341. PMID: 23771078.
34. Tomczyk J, Komarnitki J, Zalewska M, Lekszycki T, Olczak-Kowalczyk D. Fluorescence methods (VistaCam iX proof and DIAGNODent pen) for the detection of occlusal carious lesions in teeth recovered from archaeological context. Am J Phys. Anthropol. 2014;154, 525-534. 10.1002/ajpa.22542. Epub 2014 May 24. PMID: 24862036.
35. Achilleos E Rahiotis C Kavvadia K Vougiouklakis G In vivo validation of Diagnodent and Vista proof devices vs ICDAS clinical criteria on incipient carious lesions in adults Photodiagnosis Photodyn Ther 2021 34 102252 10.1016/j.pdpdt.2021.102252 33711531
Achilleos E, Rahiotis C, Kavvadia K, Vougiouklakis G. In vivo validation of Diagnodent and Vista proof devices vs ICDAS clinical criteria on incipient carious lesions in adults. Photodiagnosis Photodyn Ther. 2021;34:102252. 10.1016/j.pdpdt.2021.102252. Epub 2021 Mar 9. PMID: 33711531.33711531
36. Qudeimat MA Alomari QD Altarakemah Y Alshawaf N Honkala EJ Variables affecting the inter- and intra-examiner reliability of ICDAS for occlusal caries diagnosis in permanent molars J Public Health Dent 2016 76 1 9 16 10.1111/jphd.12105 26095924
Qudeimat MA, Alomari QD, Altarakemah Y, Alshawaf N, Honkala EJ. Variables affecting the inter- and intra-examiner reliability of ICDAS for occlusal caries diagnosis in permanent molars. J Public Health Dent. 2016;76(1):9–16. 10.1111/jphd.12105. Epub 2015 Jun 10. PMID: 26095924.26095924
37. Bücher K, Galler M, Seitz M, Hickel R, Kunzelman KH, Kühnisch J. Occlusal caries extension in relation to visual and radiographic diagnostic criteria: results from a microcomputed tomography study. Oper Dent. 2015;40(3):255-262. PMID: 25695643. 10.2341/13-128-L
