DIAGNOdent versus International Caries Detection and Assessment System (ICDAS) in Detection of Incipient Carious Lesions: A Diagnostic Accuracy study

doi:10.21203/rs.3.rs-1666175/v1

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DIAGNOdent versus International Caries Detection and Assessment System (ICDAS) in Detection of Incipient Carious Lesions: A Diagnostic Accuracy study

https://doi.org/10.21203/rs.3.rs-1666175/v1

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Objectives: The present investigation aimed at assessing the diagnostic accuracy of DIAGNOdent compared to the ICDAS-II in the detection of facial, smooth surface non-cavitated carious lesions.

Materials and methods: 60 patients were enrolled in the current study according to the eligibility criteria. There were 161 teeth with non-cavitated, white spot carious lesions and 32 sound teeth. All teeth were assessed by each examiner individually at different times without any contact using ICDAS II and DIAGNOdent. The diagnostic accuracy of DIAGNOdent device was determined, including sensitivity, specificity, overall accuracy, positive and negative predictive values and ROC curve analysis.

Results: In the current study, DIAGNOdent had overall accuracy of 84.45% with sensitivity and specificity of 87.58% and 96.87% respectively, when score 0 represented sound tooth surface, while scores 1 and 2 were considered as clinically non-cavitated carious lesions. Moreover, when only ICDAS score 1 was considered representing first visual change in enamel, DIAGNOdent had accuracy of 74.15% with sensitivity and specificity of 83.53% and 90.62% respectively. In the present study, when only ICDAS score 2 was considered representing distinct visual change in enamel, DIAGNOdent had accuracy of 100% with sensitivity and specificity of 100% and 100% respectively.

Conclusions: 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.

Clinical relevance: The overall performance of DIAGNOdent was equivalent to the visual inspection using ICDAS II, therefore, DIAGNOdent might be considered as a useful adjunctive device for detecting in vivo non-cavitated carious lesions on facial smooth surfaces.

Diagnostic accuracy

Diagnodent

Laser fluorescence

ICDAS

incipient caries

There is a current paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment of dental caries. From international caries detection and assessment system (ICDAS) to Caries Care 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 (ICCMS) and its practice version CCI have shared goals for caries management through preventing new lesions from appearing, preventing existing lesions from progression and preserving valuable tooth structure [1]. 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 [2].

Based on a recently published systematic review [3], 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 non-cavitated lesions [4]. 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[5]. 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 as a suitable method for caries detection [3]. 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, this will reflect the actual activity of carious lesions and aid in objective assessment of the incipient lesions progression [6]. Caries progression is represented numerically on the screen of the device with a scale ranging from 0-99.

A recent systematic review[7] found that both sensitivity and specificity of fluorescence-based caries assessment methods was 80%, while visual caries assessment methods had 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 [7]. However, there is limited evidence available in the current literature due to scarce in-vivo studies. Recent systematic reviews [5, 7] recommended that more in-vivo studies are warranted to assess the diagnostic accuracy of both assessment methods. Moreover, Foros et al.[3] conducted another recent systematic review and concluded that there was 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 non-cavitated 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.

The current investigation was registered in Clinical trials.gov (ID: NCT05127356) at 19/11/2021, approved by Research Ethics Committee (REC/IRB), Faculty of Dentistry, Cairo University (Approval number:11/2/22) at 22/02/2022, conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013 and reported according to STARD guidelines [8] (Figure 1). Sample size was calculated according to the results of a previous systematic review[3] 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, patients with at least one non-cavitated white spot lesions on facial smooth surfaces were included using convenient consecutive sampling. Healthy teeth were also included to assess specificity, while cavitated and arrested discoloured lesions and teeth with other developmental defects were excluded. Out of 200 patients examined, 60 patients fulfilled the eligibility criteria and written informed consent was signed by the eligible participants before enrolment in the present trial. There were 161 teeth with non-cavitated, white spot carious lesions and 32 sound teeth, which were examined to compare the diagnostic accuracy of the caries assessment methods. The examination was carried out in the main clinic of department of Conservative Dentistry, Faculty of Dentistry, Cairo University between 22-2-2022 and 24-3-2022. Before examination, teeth were cleaned and polished and all patients were assessed under standardized operating conditions; pre-set dental unit position, operating light and prolonged air drying (approximately 5 seconds).

Assessors’ calibration:

Two assessors with at least 10 years of experience in the field of Conservative Dentistry and Cariology (O.S., M. R.) were trained and calibrated to use both visual and laser assessment methods on patients 2 weeks prior to beginning of the study. Assessors were trained for using DIAGNOdent 2095 (KaVo, Biberach, Germany) laser fluorescence device according to the manufacturer’s instructions. For visual inspection some patients were recruited and assessed multiple times by both assessors independently till reaching a satisfactory calibration. The calibration process was very important to ensure that they record clinical observation in similar way.

Visual assessment using ICDAS II:

All teeth were assessed by each examiner individually at different times without any contact using International Caries Detection and Assessment System II (ICDAS II)[9]. Sound teeth were scored as 0 and non-cavitated enamel initial lesions were scored as 1 and 2.

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 non-cavitated white spot lesion and rotated around a vertical axis, three reading were obtained and the highest reading was then registered. DIAGNOdent fluorescence readings were between 0 to 99, these reading were categorized according to a previous classification[10]. Sound teeth were scored as 1 and non-cavitated enamel initial lesions were scored as 2 and 3.

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).

Statistical Analysis:

Continuous data was presented as mean and standard deviation (SD), while categorical data was 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 ROC curve analysis, in detection of non cavitated 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 were 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.

1. Demographic data:

Sixty patients participated in the current trial; 40 females and 20 males with mean age of 23.7±4.4 (ranging from 18 to 30 year). A total of 193 teeth according to the eligibility criteria were examined, including 120 anterior teeth, 56 premolars and 17 molars. Demographic data are presented in (Table 1).

Table (1): Demographic data.

Variables		Entire cohort
Total participants		60
Total investigated teeth		193
Age (years)		23.7±4.4
Gender (n/%)	Male	20 (33.33%)
	Female	40 (66.66%)
Tooth type (n/%)	Anterior	120 (62.18%)
	Premolar	56 (29.02%)
	Molar	17 (8.8%)

2. Inter-observer agreement for ICDAS-II and DIAGNOdent scoring systems:

There was almost perfect inter-examiner agreement for DIAGNOdent and ICDAS II (Kappa= 0.84 and 0.94) respectively.

3. Spearman’s Rank Correlation between ICDAS-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-value < 0.0001).

4. Distribution of ICDAS-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 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 distinct visual change in enamel according to ICDAS-II (ICDAS 2), according to DIAGNOdent scoring system, 7 were scored as outer enamel caries (DIAGNOdent score 2) and 69 were scored as inner enamel caries (DIAGNOdent score 3) (Table 2). Chi square test showed that there was a statistically significant difference in score distribution between ICDAS-II and DIAGNOdent methods (P<0.0001).

Table (2): Association between ICDAS-II and DIAGNOdent scoring systems.

		DIAGNOdent scores n (%)			Total	P value
		Sound (0-4)	Outer enamel (5-10)	Inner enamel (11-20)	Total	P value
ICDAS-II n (%)	Sound (score 0)	22 (68.7%)	10 (31.2%)	0 (0.0%)	32	<0.0001*
	Enamel (score 1)	6 (7.1%)	76 (89.4%)	3 (3.5%)	85
	Enamel (score 2)	0 (0.0%)	7 (9.2%)	69 (90.8%)	76
	Total	28	93	72	193

5. Diagnostic accuracy of DIAGNOdent:

The level of agreement between DIAGNOdent and traditional ICDAS-II in detection of smooth surface non-cavitated 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 non-cavitated 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 3). Figure 2 shows ROC curves for DIAGNOdent in caries detection on smooth surface lesions based on ICDAS-II as reference standard.

Table (3): Diagnostic accuracy of DIAGNOdent method in caries detection based on ICDAS-II as reference standard.

Negative (Healthy)	Positive (Diseased)	Criterion of DIAGNOdent	Sensitivity %	Specificity %	+PV%	-PV%	Overall diagnostic accuracy %	AUC [95% CI]	P-value
ICDAS 0	ICDAS 1 & 2	>6	87.58%	96.87%	97.7%	83.9%	84.45%	0.97 [0.93, 0.98]	P<0.001
ICDAS 0	ICDAS 1	>5	83.53%	90.62%	93%	78.6%	74.15%	0.94 [0.88, 0.98]	P<0.001
ICDAS 0	ICDAS 2	>7	100%	100%	100%	100%	100%	1 [0.96, 1.00]	P<0.001
ICDAS 1	ICDAS 2	>10	90.79%	96.47%	97.5%	87.5%	87.26%	0.98 [0.95, 0.99]	P<0.001

+PV: Positive Predictive Value, -PV: Negative Predictive Value, AUC: Area Under the Curve, CI: Confidence Interval

In vitro data suggested that laser fluorescence and visual inspection have similar accuracy [11]. There is limited evidence-based data in the literature regarding in vivo diagnostic accuracy of non cavitated carious lesions detection methods. In a previous systematic review[3] based on in vivo data, only 5 studies were eligible for meta-analysis and there was only one study assessing diagnostic accuracy of laser fluroscence (DIAGNOpen) for detection of non -cavitated 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 non-cavitated lesions in smooth facial surfaces using DIAGNOdent. The authors also reported that sensitivity and specificity of DIAGNOdent in previous in vivo studies for occlusal surface in permanent dentition was (0.48–1) and (0.54–1) respectively[3], 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 non-cavitated carious lesions using laser fluorescence needed further studies.

Visual examination is the most common used method for detection of initial carious lesions due to its convenience, reliability[12] and cost effectiveness[3]. 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 [13–16]. 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 accuracy of carious detection methods. Nevertheless, for histological assessment to be done, teeth under investigation should be extracted causing ethical issues[7]. Therefore, to assess in vivo diagnostic accuracy without histological examination, inter-examiner agreement should be used as a surrogate method to enhance accuracy[17]. The DIAGNOdent detects carious lesions through quantifying bacterial by-products (porphyrins) produced by cariogenic bacteria and detecting their biological fluorescence[18]. Furthermore, previous systematic reviews[11, 19] and other in vitro studies[14–16, 20, 21] 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 as 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[22–24]. Hence, standardized measurement protocol is required to enhance reading accuracy of DIAGNOdent. Teeth surfaces should be cleaned before measurements, 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[22–25]. Light reflection of the dental unit lamp could affect DIAGNOdent results, therefore it is very crucia; to use the same lighting conditions such as intensity, angulation, and distance during measurements [24].

In the current study, DIAGNOdent had overall accuracy of 84.45% with sensitivity and specificity of 87.58% and 96.87% respectively, when score 0 represented sound tooth surface, while scores 1 and 2 were considered as clinically non-cavitated carious lesions, which indicated excellent association between ICDAS-II and DIAGNOdent methods. Moreover, when only ICDAS score 1 was considered representing first visual change in enamel, DIAGNOdent had accuracy of 74.15% with sensitivity and specificity of 83.53% and 90.62% respectively, which also indicated 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 accuracy of 100% with sensitivity and specificity of 100% and 100% respectively, which indicated perfect association between ICDAS-II and DIAGNOdent methods. The findings presented herein were supported by two recent systematic reviews, where Thanh et al. [7] found that fluorescence based diagnostic methods had sensitivity and specificity of 80%, while Foros et al. [3] reported that the sensitivity ranged from 0.32–0.78 and the specificity ranged from 0.64–0.85.

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 [13, 26] 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 [27].

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 [28].

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 [10, 22, 28]. 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 non cavitated carious lesions [22, 29].

The ideal diagnostic tool for detection and monitoring progress of non -cavitated 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 [30]. Additionally, the diagnostic tool for incipient caries should be user friendly, easily applied in clinical situations by less experienced operators, non-invasive, cost-effective and should also provide repeatability and reproducibility among different examiners [13].

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 non-invasive preventive protocols [31]. Besides, it has been reported that treatment decisions based on combining ICDAS and DIAGNOdent had better accuracy than decisions based on ICDAS only [32].

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. Therefore, DIAGNOdent might be considered as an objective adjunctive device for detecting in vivo non-cavitated carious lesions on facial smooth surfaces.

Ethics Approval and Consent to Participate statement:

The current investigation was approved by the Research Ethics Committee (REC/IRB), Faculty of Dentistry, Cairo University (Approval number:11/2/22), conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013. The author had obtained written informed consent from all participants.

Consent to publish:

NA.

Availability of data and materials:

The data used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests:

The author declares that there are no conflicts of interest.

Funding:

No funding was obtained for this study.

Acknowledgement:

NA.

Authors’ contribution:

Omar Shaalan: Concepts, design, definition of intellectual content, sample size calculation, literature search, principal investigator, data acquisition, data analysis, statistical analysis, auditing, and manuscript preparation, editing, and review.

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No competing interests reported.

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DIAGNOdent versus International Caries Detection and Assessment System (ICDAS) in Detection of Incipient Carious Lesions: A Diagnostic Accuracy study

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