Summary of findings 1. Summary of findings table ‐ main results.
| Question | What is the diagnostic accuracy of fluorescence‐based index tests for the detection and diagnosis of early dental caries? | ||||
| Population | Children or adults who are presenting asymptomatically or who are suspected of having enamel caries (clinical studies); extracted teeth of children or adults (in vitro studies). Studies which intentionally included dentine and frank cavitations were excluded | ||||
| Index test | Fluorescence‐based devices ‐ including red, blue, and green fluorescence, suitable for use as an adjunct to a conventional clinical oral examination. Results of the index test were given on a continuous scale using a software algorithm | ||||
| Comparator test | Comparisons were made between fluorescence devices | ||||
| Target condition | Dental caries, at the threshold of caries in enamel | ||||
| Reference standard | Histology, enhanced visual examination with or without radiographs | ||||
| Action | Caries lesions confined to tooth enamel have the potential to be stabilised or even reversed, whereas the progression of carious lesions into the deeper aspects of dentine and pulp of the tooth will often require restorative treatment | ||||
| Diagnostic stage | Aimed at the general dental practitioner assessing regularly attending patients for early‐stage caries | ||||
| Quantity of evidence | 79 studies providing data for meta‐analysis (133 studies included in the systematic review) (114 datasets, 21,283 tooth surfaces of which 12,138 tooth surfaces with caries at enamel threshold or greater (57% prevalence)) | ||||
| Findings | |||||
| Estimated sensitivity (95% CI)a | 0.70 (0.64 to 0.75) at median fixed specificity of 0.78; 0.60 (0.54 to 0.65) at upper quartile fixed specificity of 0.90 | ||||
| DOR (95% CI) | 14.12 (11.17 to 17.84) | ||||
| Effect per 1000 tooth sites or surfaces assessed | Numbers applied to a hypothetical cohort of 1000 tooth sites or surfaces: sensitivity at fixed specificity 0.78 (95% CI) | Numbers applied to a hypothetical cohort of 1000 tooth sites or surfaces: sensitivity at fixed specificity 0.90 (95% CI) | Test accuracy Certainty of the evidence | ||
| Outcome | Pre‐test probability 28%b | Pre‐test probability 57%b | Pre‐test probability 28%b | Pre‐test probability 57%b | |
| True positives (patients with early enamel caries) | 196 (179 to 210) | 399 (365 to 428) | 168 (151 to 182) | 342 (308 to 371) | ⊕⊕⊝⊝ LOW |
| False negatives (patients incorrectly classified as not having early enamel caries) | 84 (70 to 101) | 171 (142 to 205) | 112 (98 to 129) | 228 (199 to 262) | |
| True negatives (patients without early enamel caries) | 562 (526 to 598) | 335 (314 to 357) | 648 (626 to 662) | 387 (374 to 396) | |
| False positives (patients incorrectly classified as having early enamel caries) | 158 (122 to 194) | 95 (73 to 116) | 72 (58 to 94) | 43 (34 to 56) | |
| Limitations | |||||
| Risk of bias | Of the 79 studies included in the meta‐analysis: patient selection was registered as having a low risk of bias due to the use of consecutive or random sampling in 9 studies, avoiding a case‐control design (79 studies), and avoiding inappropriate exclusions (64 studies). A low risk of bias was observed when the index tests could not be influenced by the reference standard (61 studies) and where thresholds were clearly reported (50 studies). There was a low risk of bias when the reference standard correctly classified the target condition (49 studies) and where the reference standard was interpreted without knowledge of the index test (49 studies). Low risk of bias was allocated for flow and timing when there was no concern regarding the interval between tests (79 studies), the same reference standard was used for all tooth surfaces (68 studies), and all tooth surfaces were reported in the analysis (65 studies) Risk of bias for all results included in the review (133) is reported in the main text |
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| Applicability of evidence to the review question | Patient selection was considered to be a high concern in studies where extracted teeth were used (78 studies). Inappropriately defined thresholds for the index test also resulted in high concern for applicability, this occurred when early enamel caries were categorised with the sound teeth (1 study) and for reference standard (4 studies). The dominance of in vitro studies also means that information on how the results of these devices are used to support diagnosis, as opposed to pure detection, is extremely limited | ||||
| Certainty of the evidence | We downgraded the certainty of the evidence by 2 levels in total for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the high number of in vitro studies, and inconsistency due to the substantial variability in results | ||||
a2 illustrative examples of points on the SROC curve fixed at the median specificity of 0.78 followed by upper quartile specificity of 0.90. bHypothetical cohorts of 1000 lesions are presented for numbers estimated at prevalence of 28% and 57% of enamel caries prevalence. Based on consultation with clinical colleagues, the lower prevalence figure addresses the concern that the higher prevalences of 57% are not representative of the general population and is taken from the level of cavitated teeth in the UK Adult Dental Health Survey (Steele 2011). The higher prevalence figure is taken from the total number of observed caries in the included studies divided by the total number of included tooth surfaces.
CI: confidence interval; DOR: diagnostic odds ratio; SROC: summary receiver operating characteristic plot.