Cochrane · DTA · CD013811

Fluorescence devices for the detection of dental caries

Macey, R, Walsh, T, Riley, P, et al. · Cochrane Database of Systematic Reviews · 2020 · Cochrane Library

Oral HealthDental cariesAMSTAR 2: not assessed
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
28
current version
GRADE rated
3
No studies
1
Included studies
133
as reported
No studies 1 · 3.6%Ungraded 24 · 85.7%Very low 0 · 0%Low 3 · 10.7%Moderate 0 · 0%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

ElementPlanned (methods)Found (results)
PopulationParticipants seemingly asymptomatic for dental caries, including those who may have carious lesions undetected at enrolment; children, adolescents, and adults all eligible; participants explicitly recruited with caries into dentine or frank cavitation were excluded21,283 tooth surfaces from 79 studies in the meta-analysis (114 datasets); 133 studies in the review; 62% (83/133) performed on extracted teeth (in vitro); permanent dentition (70) and primary dentition (40); studies published 1998-2019
InterventionFluorescence-based devices used alone or as an adjunct to a conventional visual examination (red fluorescence: DIAGNOdent, DIAGNOdent pen, MidWest, Canary System; blue fluorescence: VistaProof, SoproLife, Spectra; green fluorescence: QLF)Red fluorescence (n=84 datasets; DIAGNOdent n=46, DIAGNOdent pen n=34, MidWest n=4); Blue fluorescence (n=21 datasets; VistaProof n=18, SoproLife n=3); Green fluorescence/QLF (n=9); Combined visual+radiograph+DIAGNOdent (n=1)
ComparisonReference standard: histology; enhanced visual examination; radiographs; excavation; composite reference standards also acceptedHistology (n=78 datasets); Enhanced visual assessment (n=25); Radiograph (n=6); Excavation (n=5)
OutcomesDiagnostic test accuracy (sensitivity and specificity) for detection/diagnosis of coronal early/initial (non-cavitated) enamel caries at the D1 threshold; QUADAS-2 qualityDiagnostic accuracy at enamel (D1) threshold (n=114 datasets): DOR 14.12 (95% CI 11.17 to 17.84); sensitivity 0.70 (0.64 to 0.75) at fixed specificity 0.78 and 0.60 (0.54 to 0.65) at fixed specificity 0.90
Study designsDiagnostic accuracy study designs (single-gate studies comparing a fluorescence test with a reference standard; RCTs of diagnostic test accuracy; case-control accuracy studies); in vitro and in vivoAll included studies were cross-sectional single-gate design; no case-control or randomised controlled trials were identified
TimingA period of up to three months between the index test and the reference standard was deemed acceptableNot reported

Search date: 2019-05. Databases: MEDLINE Ovid; Embase Ovid; US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov; World Health Organization International Clinical Trials Registry Platform

Questions and results

All fluorescence-based devices (red, blue, and green fluorescence combined) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
16 questions
OutcomeEffectEvidenceStatus / GRADE
Diagnostic odds ratio (DOR) by subgroup: Medium dentine-caries prevalence (15% to 34%) (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Medium dentine-caries prevalence (15% to 34%)
DOR 15.39 [11.07, 21.41]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Single site per tooth (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Single site per tooth
DOR 15.96 [12.26, 20.77]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Histology or excavation reference standard (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Histology or excavation reference standard
DOR 13.49 [10.25, 17.76]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Permanent/mixed dentition (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Permanent/mixed dentition
DOR 15.21 [11.35, 20.37]NRUngraded
Sensitivity at fixed upper-quartile specificity 0.90 (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Sensitivity 0.60 [0.54, 0.65]79 studiesLow
Downgraded: risk of bias, inconsistency, indirectness
Diagnostic odds ratio (DOR) by subgroup: Enhanced visual examination reference standard (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Enhanced visual examination reference standard
DOR 19.32 [12.37, 30.17]NRUngraded
Diagnostic odds ratio (DOR) (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
DOR 14.12 [11.17, 17.84]79 studiesLow
Downgraded: risk of bias, inconsistency, indirectness
Sensitivity at fixed median specificity 0.78 (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Sensitivity 0.70 [0.64, 0.75]79 studiesLow
Downgraded: risk of bias, inconsistency, indirectness
Diagnostic odds ratio (DOR) by subgroup: Low dentine-caries prevalence (<=14%) (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Low dentine-caries prevalence (<=14%)
DOR 11.10 [6.88, 17.91]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Radiography reference standard (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Radiography reference standard
DOR 6.21 [2.58, 14.97]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: High dentine-caries prevalence (>=35%) (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · High dentine-caries prevalence (>=35%)
DOR 14.59 [9.18, 23.22]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Primary dentition (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Primary dentition
DOR 12.34 [8.44, 18.04]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Multiple sites per tooth (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Multiple sites per tooth
DOR 9.46 [5.91, 15.14]18 studiesUngraded
Diagnostic odds ratio (DOR) by subgroup: Smooth or secondary-caries surfaces (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Smooth or secondary-caries surfaces
DOR 13.41 [5.58, 32.25]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Proximal surfaces (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Proximal surfaces
DOR 13.06 [7.52, 22.67]NRUngraded
Diagnostic odds ratio (DOR) by subgroup: Occlusal surfaces (detection of early enamel caries, D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies) · Occlusal surfaces
DOR 14.29 [10.92, 18.72]NRUngraded

Red fluorescence devices (DIAGNOdent, DIAGNOdent pen, MidWest; excitation wavelength >655 nm) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic odds ratio (DOR) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
DOR 12.75 [9.74, 16.68]68 studiesUngraded

Blue fluorescence devices (VistaProof, SoproLife, Spectra; wavelength 400-450 nm) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic odds ratio (DOR) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
DOR 18.47 [10.59, 32.20]20 studiesUngraded

Green fluorescence devices (quantitative light-induced fluorescence, QLF; wavelength ~370-405 nm) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic odds ratio (DOR) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
DOR 19.49 [9.01, 42.18]9 studiesUngraded

DIAGNOdent (KaVo; red laser fluorescence, 655 nm) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic accuracy (sensitivity and specificity) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Analysed as a separate index test (coupled forest plot and SROC plot, Figure 22 / Figure 23; Appendix 5); no summary DOR or sensitivity/specificity point reported numerically in the text. 46 datasets, 7316 tooth sites.45 studiesUngraded

DIAGNOdent pen (KaVo; red laser fluorescence, 655 nm) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic accuracy (sensitivity and specificity) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Analysed as a separate index test (coupled forest plot and SROC plot, Figure 22 / Figure 23; Appendix 5); no summary DOR or sensitivity/specificity point reported numerically in the text. 34 datasets, 6842 tooth sites.32 studiesUngraded

VistaProof (Durr Dental; blue fluorescence, 405 nm) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic accuracy (sensitivity and specificity) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Analysed as a separate index test (coupled forest plot and SROC plot, Figure 24 / Figure 25; Appendix 5); no summary DOR or sensitivity/specificity point reported numerically in the text. 18 datasets, 2402 tooth sites.17 studiesUngraded

SoproLife (ACTEON; blue fluorescence) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic accuracy (sensitivity and specificity) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Analysed as a separate index test (coupled forest plot and SROC plot, Figure 24 / Figure 25; Appendix 5); no summary DOR or sensitivity/specificity point reported numerically in the text. 3 datasets, 1027 tooth sites.3 studiesUngraded

MidWest (DENTSPLY; red fluorescence, red/green light and sound signal) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic accuracy (sensitivity and specificity) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Analysed as a separate index test (coupled forest plot and SROC plot, Figure 22 / Figure 23; Appendix 5); no summary DOR or sensitivity/specificity point reported numerically in the text. 4 datasets, 356 tooth sites.4 studiesUngraded

Combined index test: visual examination + radiograph + DIAGNOdent (Alomari 2015) vs Reference standard: histology

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
2 questions
OutcomeEffectEvidenceStatus / GRADE
Sensitivity for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Sensitivity 0.82 [0.75, 0.88]1 studyUngraded
Specificity for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
Specificity 0.65 [0.38, 0.86]1 studyUngraded

Canary System (Quantum Dental Technologies; red fluorescence, scale 0-100) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Outcome NR
Up to 3 months between index test and reference standard (in vivo studies)
The Canary System was not used by any included study.0 studiesNo studies

Spectra caries detection device (Air Techniques; blue fluorescence) vs Reference standard: histology, enhanced visual examination with or without radiographs, or excavation

Population: Children or adults presenting asymptomatically or suspected of having enamel caries (in vivo/clinical studies); extracted teeth of children or adults (in vitro studies); participants explicitly recruited with caries into dentine or frank cavitation were excluded
1 question
OutcomeEffectEvidenceStatus / GRADE
Diagnostic accuracy (sensitivity and specificity) for detection of early enamel caries (D1 threshold)
Up to 3 months between index test and reference standard (in vivo studies)
The Spectra caries detection device fits into the blue fluorescence category but no studies provided data for inclusion in the meta-analysis (Markowitz 2015).1 studyUngraded