| Abstract|| |
Aim: The present investigation aimed at assessing the diagnostic accuracy of DIAGNOdent compared to the International Caries Detection and Assessment System-II (ICDAS-II) in the detection of facial, smooth surface noncavitated carious lesions.
Settings and Design: Sixty patients were enrolled in the current study according to the eligibility criteria. There were 161 teeth with noncavitated, white spot carious lesions and 32 sound teeth.
Materials and Methods: Before examination, teeth were cleaned and polished and all patients were assessed under standardized operating conditions: preset dental unit position, operating light, and prolonged air drying (approximately 5 s). All teeth were assessed by two calibrated examiners individually without any contact using ICDAS-II and DIAGNOdent.
Statistical Analysis: The diagnostic accuracy of DIAGNOdent device was determined, including sensitivity, specificity, overall accuracy, positive and negative predictive values, and receiver operating characteristic curve analysis. Chi-square test was conducted to compare the distribution of ICDAS-II and DIAGNOdent scores. Inter-observer agreement between assessors was evaluated using Cohen's kappa test.
Results: In the current study, DIAGNOdent had an overall accuracy of 84.45% with sensitivity and specificity of 87.58% and 96.87%, respectively, and +PV and −PV of 97.7% and 83.9%, respectively, when score 0 represented sound tooth surface, while scores 1 and 2 were considered clinically noncavitated carious lesions. Moreover, when only ICDAS score 1 was considered representing first visual change in enamel, DIAGNOdent had an accuracy of 74.15% with sensitivity and specificity of 83.53% and 90.62%, respectively, and +PV and −PV of 93% and 78.6%, respectively. In the present study, when only ICDAS score 2 was considered representing distinct visual change in enamel, DIAGNOdent had an accuracy of 100% with sensitivity and specificity of 100% and 100%, respectively, and +PV and −PV of 100% and 100%, respectively.
Conclusions: The overall performance of DIAGNOdent was equivalent to the visual inspection using ICDAS-II. DIAGNOdent might be considered a useful adjunctive device for detection and monitoring development of noncavitated carious lesions on facial smooth surfaces.
Keywords: Accuracy; caries; DIAGNOdent; incipient; International Caries Detection and Assessment System
|How to cite this article:|
Shaalan OO. DIAGNOdent versus International Caries Detection and Assessment System in detection of incipient carious lesions: A diagnostic accuracy study. J Conserv Dent 2023;26:199-206
|How to cite this URL:|
Shaalan OO. DIAGNOdent versus International Caries Detection and Assessment System in detection of incipient carious lesions: A diagnostic accuracy study. J Conserv Dent [serial online] 2023 [cited 2023 Jun 10];26:199-206. Available from: https://www.jcd.org.in/text.asp?2023/26/2/199/371798
| Introduction|| |
There is a current paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment of dental caries. Dental caries is considered a dynamic process of demineralization and remineralization depending on the balance between risk and protective factors. From the International Caries Detection and Assessment System (ICDAS) to the CariesCare International (CCI), the key aspects for diagnostic criteria of dental caries include lesion detection, lesion assessment, and finally, caries diagnosis. The newly introduced International Caries Classification and Management System and its practice version CCI have shared goals for caries management through avoiding occurrence of new lesions, preventing existing lesions from progression, and preserving valuable tooth structure. Early detection of initial carious lesions aids in clinical decision-making during management, with either no care advised, preventive care advised, or conservative operative care advised. Moreover, after COVID-19 pandemic, there was an increase in the awareness of dental caries prevention through primary and secondary levels of prevention. This does not only apply on the medical model of treatment, with its benefits to the patient but also minimizes aerosol-generating procedures.
Based on a recently published systematic review, visual assessment remains the methods of choice for detection of caries among all surfaces and dentitions either permanent or deciduous. The ICDAS-II was suggested in Baltimore, Maryland, March 2005, showing considerable diagnostic accuracy and reproducibility in detection of carious lesions, especially noncavitated lesions. Therefore, this method was considered a reliable caries detection method in most clinical conditions and has been recommended to be used in daily clinical practice. However, visual examination is subjective and is highly dependent on the dentist's skills and experience. Besides visual detection systems, laser fluorescence assessment was also considered a suitable method for caries detection. One of these methods is DIAGNOdent 2095 (KaVo, Biberach, Germany), which is based on fluorescence absorption of bacterial by-products from carious surfaces using a diode laser of 655 nm wavelength, and this will reflect the actual activity of carious lesions and aid in objective assessment of the incipient lesions' progression. Caries progression is represented numerically on the screen of the device with a scale ranging from 0 to 99.
A recent systematic review found that both sensitivity and specificity of fluorescence-based caries assessment methods were 80%, while visual caries assessment methods had a sensitivity of 80% and specificity of 75%. Laboratory data demonstrated that both the visual and the fluorescence methods had similar diagnostic accuracy and were both reliable for detection of initial carious lesions., However, there is limited evidence available in the current literature due to scarce in vivo studies. Recent systematic reviews, recommended that more in vivo studies are warranted to assess the diagnostic accuracy of both assessment methods. Moreover, Foros et al. conducted another recent systematic review and concluded that there was a lack of in vivo trials assessing the diagnostic accuracy of DIAGNOdent in detecting carious lesions of facial smooth surfaces.
Given the current gap of knowledge, the present investigation aimed at assessing the diagnostic accuracy of DIAGNOdent compared to the ICDAS-II visual assessment as a reference standard in the detection of facial, smooth surface noncavitated carious lesions. The null hypothesis tested, was that there will be no difference between both methods in detecting initial carious lesions in facial smooth surfaces.
| Materials and Methods|| |
The current investigation was registered in ClinicalTrials.gov (ID: NCT05127356) at November 19, 2021, approved by the Research Ethics Committee (Approval Number: 11-2-22) at February 22, 2022, conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013 and reported according to STARD guidelines. Sample size was calculated according to the results of a previous systematic review in which the area under the curve (AUC) for diagnostic accuracy of fluorescent camera for buccal smooth surface carious lesions was 0.84 and AUC for diagnostic accuracy of visual examination was 0.99. By adopting an alpha (α) level of 0.05 (5%), power = 80%. The predicted sample size (n) was a total of 58 patients. Sample size calculation was performed using MedCalc software, version 19 for windows (MedCalc Software Ltd., Ostend, Belgium).
A total of 200 patients ranging from 18 to 30 years old were examined, and patients with at least one noncavitated white spot lesion on facial smooth surfaces were included using convenient consecutive sampling. Healthy teeth were also included to assess specificity, while cavitated and arrested discolored lesions and teeth with other developmental defects or teeth with dental restorations were excluded. Out of the 200 patients examined, 60 patients fulfilled the eligibility criteria and were recruited from the clinic of the department of conservative dentistry. Written informed consent was signed by the eligible participants before enrollment in the present trial. There were 161 teeth with noncavitated, incipient carious lesions and 32 sound teeth in the current study. Carious and sound teeth were examined to compare the diagnostic accuracy of both caries assessment methods. The examination was carried out in the main clinic of the department of conservative dentistry between February 22, 2022 and March 24, 2022. Before examination, teeth were cleaned and polished using Pro-Brush (Kerr, Orange, CA, USA) and all patients were assessed under standardized operating conditions: preset dental unit position, operating light, and prolonged air drying (approximately 5s). [Figure 1] represents the STARD flow diagram to report the flow of participants in the current study.
|Figure 1: STARD flow diagram to report flow of participants and lesions in the study|
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Two assessors were trained and calibrated to use both visual and laser assessment methods 2 weeks prior to the beginning of the study. Assessors were trained for using DIAGNOdent 2095 (KaVo, Biberach, Germany) laser fluorescence device according to the manufacturer's instructions and were trained to assess teeth using the ICDAS system., For calibration, ten patients were recruited and assessed independently by both assessors using both methods till reaching a satisfactory calibration, whenever there was a disagreement, they discussed to reach for a consensus. There was almost perfect inter-examiner agreement for DIAGNOdent and ICDAS-II (kappa = 0.86 and 0.97, respectively) during calibration period.
Visual assessment using the International Caries Detection and Assessment System-II
All teeth were assessed by each examiner individually without any contact using ICDAS-II. Sound teeth were scored as 0 and noncavitated enamel initial lesions were scored as 1 and 2. ICDAS-II scores were as follows:
- Code 0: Sound tooth surface
- Code 1: First visual change in enamel
- Code 2: Distinct visual change in enamel when viewed wet
- Code 3: Localized enamel breakdown due to caries with no visible dentin
- 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.
Laser fluorescence assessment using DIAGNOdent
All teeth were assessed by each examiner individually at different times without any contact using DIAGNOdent 2095 (KaVo, Biberach, Germany) laser fluorescence device. The device was calibrated using the given ceramic standard, followed by acquiring baseline value through measuring fluorescence of a sound spot on the smooth surface of the tooth. The tip of the DIAGNOdent was then applied on the noncavitated white spot lesion and rotated around a vertical axis, three readings were obtained, and the highest reading was then registered. DIAGNOdent fluorescence readings were between 0 and 99; these readings were categorized according to a previous classification. Sound teeth were scored as 1 and noncavitated enamel initial lesions were scored as 2 and 3. DIAGNOdent categorical scores were as follows:
- Score 1: 0–4 (healthy tooth structure)
- Score 2: 5–10 (outer half enamel caries)
- Score 3: 11–20 (inner half enamel caries)
- Score 4: 21+ (dentin caries).
Continuous data were presented as mean and standard deviation, while categorical data were presented as frequencies (n) and percentages (%). The diagnostic accuracy of DIAGNOdent device was determined, including sensitivity, specificity, overall accuracy, positive and negative predictive values, and receiver operating characteristic (ROC) curve analysis, in detection of noncavitated carious lesions in facial smooth surfaces compared with traditional ICDAS-II. Spearman's rank correlation was used to measure the level of correlation between ICDAS-II scores and DIAGNOdent readings. Chi-square test was conducted to compare the distribution of ICDAS-II and DIAGNOdent scores. Inter-observer agreement between assessors regarding ICDAS-II and DIAGNOdent modalities was evaluated using Cohen's kappa test. Statistical analysis was performed using MedCalc software, version 19 for Windows (MedCalc Software Ltd, Ostend, Belgium), and the significance level was set at P ≤ 0.05.
| Results|| |
Sixty patients participated in the current trial; 40 females (66.66%) and 20 males (33.33%) with a mean age of 23.7 ± 4.4 (ranging from 18 to 30 years). A total of 193 teeth according to the eligibility criteria were examined, including 120 anterior teeth (62.18%), 56 premolars (29.02%), and 17 molars (8.8%).
Inter-observer agreement for the International Caries Detection and Assessment System-II and DIAGNOdent scoring systems
There was almost perfect inter-examiner agreement for DIAGNOdent and ICDAS-II (kappa = 0.84 and 0.94, respectively).
Spearman's rank correlation between the International Caries Detection and Assessment System-II scores and DIAGNOdent readings
Spearman's rank correlation coefficient was computed for the highest scores/measurements given by both operators for each method. The calculation resulted in a strongly significant positive correlation between ICDAS-II scores and DIAGNOdent readings (r = 0.892, P < 0.0001).
Distribution of the International Caries Detection and Assessment System-II scores and DIAGNOdent readings
A total of 193 teeth were examined in this study. According to ICDAS-II, 32 teeth were scored as sound (ICDAS 0), of which 22 of them were scored as sound using the DIAGNOdent device (DIAGNOdent score 1) and 10 were scored as having outer enamel caries (DIAGNOdent score 2). Meanwhile, 85 teeth were scored as the first visual change in enamel based on ICDAS-II (ICDAS 1), when these teeth were assessed by the DIAGNOdent method, 6 of them were scored as sound (DIAGNOdent score 1) and 76 were scored as outer enamel caries (DIAGNOdent score 2) and 3 were scored as inner enamel caries (DIAGNOdent score 3). Furthermore, 76 teeth were scored as a distinct visual change in enamel according to ICDAS-II (ICDAS 2), of which 7 were scored as outer enamel caries (DIAGNOdent score 2) and 69 were scored as inner enamel caries (DIAGNOdent score 3) according to DIAGNOdent scoringsystem [Table 1]. Chi-square test showed that there was a statistically significant difference in score distribution between ICDAS-II and DIAGNOdent methods (P < 0.0001).
|Table 1: Association between the International Caries Detection and Assessment System-II and DIAGNOdent scoring systems|
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Diagnostic accuracy of DIAGNOdent
The level of agreement between DIAGNOdent and traditional ICDAS-II in detection of smooth surface noncavitated carious lesions was also investigated in this study. The reference standard was ICDAS-II, score 0 represented healthy tooth surface (negative), while ICDAS scores 1 and 2 represented diseased noncavitated carious lesions (positive). To compare the level of agreement within ICDAS 1 and 2 individually, ICDAS 1 was considered healthy, while ICDAS 2 was considered diseased [Table 2]. [Figure 2] shows ROC curves for DIAGNOdent in caries detection on smooth surface lesions based on ICDAS-II as a reference standard.
|Table 2: Diagnostic accuracy of DIAGNOdent method in caries detection based on the International Caries Detection and Assessment System-II as reference standard|
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|Figure 2: ROC curves for DIAGNOdent in caries detection on smooth surface lesions based on ICDAS-II as reference standard. (a) ROC curve for DIAGNOdent in caries detection on smooth surface lesions based on ICDAS-II as reference standard (negative: ICDAS 0, positive: ICDAS 1 and 2). (b) ROC curve for DIAGNOdent in caries detection on smooth surface lesions based on ICDAS-II as reference standard (negative: ICDAS 0, positive: ICDAS 1). (c) ROC curve for DIAGNOdent in caries detection on smooth surface lesions based on ICDAS-II as reference standard (negative: ICDAS 0, positive: ICDAS 2). (d) ROC curve for DIAGNOdent in caries detection on smooth surface lesions based on ICDAS-II as reference standard (negative: ICDAS 1, positive: ICDAS 2). ROC: Receiver operating characteristic, ICDAS: International Caries Detection and Assessment System|
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| Discussion|| |
In vitro data suggested that laser fluorescence and visual inspection have similar accuracy., There are limited evidence-based data in the literature regarding in vivo diagnostic accuracy of noncavitated carious lesions detection methods. In a previous systematic review based on in vivo data, only 5 studies were eligible for meta-analysis and there was only one study assessing diagnostic accuracy of laser fluorescence (DIAGNOpen) for detection of noncavitated lesions in smooth facial surfaces with sensitivity and specificity of 0.32–0.78 and 0.64–0.85, respectively. There were no in vivo diagnostic accuracy studies for detection of noncavitated lesions in smooth facial surfaces using DIAGNOdent. The authors also reported that the sensitivity and specificity of DIAGNOdent in previous in vivo studies for occlusal surface in permanent dentition were 0.48–1 and 0.54–1, respectively; there was a huge heterogeneity among studies with wide confidence intervals for the sensitivity and specificity. Moreover, comparison between in vitro and in vivo data regarding the accuracy of laser fluorescence for detection of incipient carious lesions showed that in vitro data exhibited better accuracy. Therefore, in vivo assessment of noncavitated carious lesions using laser fluorescence needed further studies.
Visual examination is the most commonly used method for detection of initial carious lesions due to its convenience, reliability, and cost-effectiveness. It is well established in the current literature that direct visual examination has good validity for detection of white spot lesions, where diagnosis is based on clinical appearance and texture of enamel rather than by-products of bacteria detected by laser fluorescence.,,, Authenticating visual examination method for in vivo assessment in trials had many drawbacks compared to histological assessment, which is universally accepted as the reference gold standard to assess the accuracy of carious detection methods. Nevertheless, for histological assessment to be done, teeth under investigation should be extracted causing ethical issues. Therefore, to assess in vivo diagnostic accuracy without histological examination, inter-examiner agreement should be used as a surrogate method to enhance accuracy. The DIAGNOdent detects carious lesions through quantifying bacterial by-products (porphyrins) produced by cariogenic bacteria and detecting their biological fluorescence. Furthermore, previous systematic reviews, and other in vitro studies,,,, showed that laser fluorescence detection methods such as DIAGNOdent and DIAGNOdent Pen had high in vitro sensitivity and specificity for detecting initial white spot lesions.
Although DIAGNOdent could be considered a reliable tool for caries diagnosis, some requirements are needed to minimize false-positive readings in clinical practice. For instance, DIAGNOdent overestimates readings for any minor alterations in properties of the dental substrate. Confounders such as stains, calculus, plaque, and degree of mineralization can affect the accuracy of readings.,, Hence, standardized measurement protocol is required to enhance reading accuracy of DIAGNOdent. Teeth surfaces should be cleaned before measurements and dryness should be optimum to standardize moisture content of teeth, as it affects light scattering due to difference in refractive index between air and water.,,, Light reflection of the dental unit lamp could affect DIAGNOdent results; therefore, it is very crucial to use the same lighting conditions such as intensity, angulation, and distance during measurements.
In the current study, DIAGNOdent had an overall accuracy of 84.45% with sensitivity and specificity of 87.58% and 96.87%, respectively, and +PV and −PV of 97.7% and 83.9%, respectively, when score 0 represented sound tooth surface, while scores 1 and 2 were considered clinically noncavitated carious lesions, which indicated an excellent association between ICDAS-II and DIAGNOdent methods. Moreover, when only ICDAS score 1 was considered representing first visual change in enamel, DIAGNOdent had an accuracy of 74.15% with sensitivity and specificity of 83.53% and 90.62%, respectively, and +PV and −PV of 93% and 78.6%, respectively, which also indicated an excellent association between ICDAS-II and DIAGNOdent methods. In the present study, when only ICDAS score 2 was considered representing distinct visual change in enamel, DIAGNOdent had an accuracy of 100% with sensitivity and specificity of 100% and 100%, respectively, and +PV and −PV of 100% and 100%, respectively, which indicated a perfect association between ICDAS-II and DIAGNOdent methods. The findings presented herein were supported by two recent systematic reviews, where Thanh et al. found that fluorescence-based diagnostic methods had a sensitivity and specificity of 80%, while Foros et al. reported that the sensitivity ranged from 0.32 to 0.78 and the specificity ranged from 0.64 to 0.85.
The current findings noticed that DIAGNOdent had less accuracy regarding early visual changes in enamel when compared to ICDAS-II, while for the more extended distinct visual change in enamel, DIAGNOdent demonstrated perfect accuracy. These observations were in line with previous studies, validating fluorescence devices for evaluation of white spot lesions, showing less accuracy with early lesions and better accuracy with more extended lesions. This may be attributed to the low level of bacterial by-products in early incipient enamel lesions.
In the present investigation, there was a strongly significant positive correlation (r = 0.892) between ICDAS-II scores and DIAGNOdent readings, which denotes that as the scores of ICDAS-II increased, the DIAGNOdent readings increased, and vice versa. This was also in agreement with another trial reporting a good correlation (r = 0.71) between ICDAS-II and DIAGNOpen readings.
Furthermore, the present findings found almost perfect inter-examiner agreement for DIAGNOdent and ICDAS-II (kappa = 0.83844 and 0.94311, respectively), which was supported by similar results from other trials.,, This emphasizes the importance of training and calibration before undergoing diagnostic accuracy studies. The examiners' calibration is very crucial to ensure high reproducibility during assessment of noncavitated carious lesions.,
The ideal diagnostic tool for detection and monitoring progress of noncavitated white spot lesions should have high sensitivity and specificity. For a diagnostic test to be beneficial, the summation of sensitivity and specificity should be at least 1.5. Additionally, the diagnostic tool for incipient caries should be user-friendly, easily applied in clinical situations by less experienced operators, noninvasive, cost-effective, and should also provide repeatability and reproducibility among different examiners.
Combining DIAGNOdent and direct visual examination for diagnosis of facial smooth surfaces might be considered beneficial, through merging the merits of assessing enamel's mineral quantity together with texture and appearance. This could help clinicians to enhance their diagnostic efficiency and decision-making during management of early enamel lesions, thus halting lesions' progression using noninvasive preventive protocols.,,, Besides, it has been reported that treatment decisions based on combining ICDAS and DIAGNOdent had better accuracy than decisions based on ICDAS only.
| Conclusions|| |
In the current investigation, DIAGNOdent has shown high sensitivity and specificity and excellent association with ICDAS-II, despite being less accurate in detecting the first visual change in enamel compared to visual examination. The overall performance of DIAGNOdent was equivalent to the visual inspection using ICDAS-II, so the null hypothesis could not be rejected. DIAGNOdent might be considered a useful adjunctive device for detection and monitoring development of noncavitated carious lesions on facial smooth surfaces.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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Dr. Omar Osama Shaalan
35 Mohamad Farid Street, El Hay El Motamayz, Sixth of October City, Giza
Source of Support: None, Conflict of Interest: None
[Figure 1], [Figure 2]
[Table 1], [Table 2]