Achilleos 2013.

Study characteristics
Patient Sampling	Method of sampling: selected Included conditions: no cavitation Teeth: permanent molars and premolars Sealants: unclear Surface: occlusal
Patient characteristics and setting	Age: not reported Sex: not reported Ethnicity: not reported Country: Greece Setting: extracted for orthodontic purposes Number of participants/teeth/sites: 38 teeth Prevalence: enamel 0.95, dentine 0.39
Index tests	Category of test: DIAGNOdent pen and VistaProof Sequence of test(s): visual, then index tests, then reference standard Examiner training and calibration: experienced, trained, and calibrated dentists Teeth cleaning prior to examination: calculus and debris were removed by paste and brush burr Tooth drying prior to examination: yes Threshold applied: DIAGNOdent pen: 0‐13 sound, 14‐20 enamel (outer), 21‐29 enamel (deep), > 30 dentinal VistaProof: "software shows the region of the teeth that emits fluorescence and an outcome value in different colors, ranging from 0 to 5, which defines the caries lesions extension according to the manufacturer’s recommendations. Numerical and color scales were: 1.0–1.5/blue shows beginning enamel caries, 1.5–2.0/red shows deep enamel caries, 2.0–2.5/orange shows dentin caries, and 2.5–5.0/yellow shows deep dentin caries" Device specifics: sapphire fibre tip
Target condition and reference standard(s)	Category: histology Sequence of index test and reference standard: following index test Training of examiner: experienced, same examiner as index test Blinding to index test: no Multiple tests: no Site selection: 3 sections Target condition: caries free, early enamel, deep enamel, outer dentine, dentine, deep dentine
Flow and timing	Participants with index test but no reference standard: 0 Participants with reference standard but no index test: 0 Time interval between tests: minimal Participants receiving both tests but excluded from results: 0
Comparative
Notes	Multiple examiners reported so examiner one values reported
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	No
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Yes
Could the selection of patients have introduced bias?		High risk
Are there concerns that the included patients and setting do not match the review question?			High
DOMAIN 2: Index Test (All)
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
If a threshold was used, was it pre‐specified?	Yes
If multiple tests were applied were different examiners used for each (in vivo)?	No
Could the conduct or interpretation of the index test have introduced bias?		Low risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
DOMAIN 2: Index Test (Green fluorescence)
DOMAIN 2: Index Test (Blue fluorescence)
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
If a threshold was used, was it pre‐specified?	Yes
If multiple tests were applied were different examiners used for each (in vivo)?	No
Could the conduct or interpretation of the index test have introduced bias?		Low risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
DOMAIN 2: Index Test (Red fluorescence)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		Low risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		Low risk