Shimada 2010.

Study characteristics
Patient Sampling	Method of sampling: selected Included conditions: "stained occlusal fissures and/or small open caries lesions with diameter within 1 mm"; "36 non‐cavitated teeth and 26 cavitated teeth" ‐ not clear on severity of cavitation, concern that no obviously sound surfaces were sampled Teeth: permanent molars Sealants: not reported Restorations: not reported Surface: occlusal
Patient characteristics and setting	Age: not reported Sex: not reported Ethnicity: not reported Country: Japan Setting: extracted teeth Number of participants/teeth/sites: 62 teeth, 111 sites Prevalence: enamel 0.86, dentine 0.38
Index tests	Category of test: SS‐OCT Sequence of test(s): visual test before OCT (examiners blinded to results of visual test), both prior to reference standard Examiner training and calibration: 3 experienced dentists, with training session for calibration Threshold applied: sound, superficial demineralisation of enamel, enamel breakdown due to the caries, dentine caries Device specifics: SS‐OCT (Santec OCT‐20001, Santec Co, Komaki, Japan); "Axial resolution of the system is 11 mm in air, which corresponds to 8 mm in soft tissue and 6.8 mm in enamel, assuming refractive indices of about 1.38 and 1.62, respectively"
Target condition and reference standard(s)	Category: histology ‐ using confocal laser scanning microscope Sequence of index test and reference standard: index test then reference standard Training of examiner: "Two examiners with sufficient experience in histopathological study of caries" Blinding to index test: unclear Multiple tests: no Site selection: "performed on the investigation site" Target condition: sound, superficial enamel demineralisation, enamel breakdown, dentine caries
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
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?	Unclear
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 tests)
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 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