Shimada 2014.

Study characteristics
Patient Sampling	Method of sampling: selected; "Ninety‐one unrestored proximal surfaces of premolars and molars, with/without the possibility of caries, were selected for this study" Included conditions: sound and early lesions Teeth: permanent molar and premolars Sealants: not reported Restorations: no Surface: approximal
Patient characteristics and setting	Age: 21 to 64 years (mean 38 years) Sex: not reported Ethnicity: not reported Country: Japan Setting: Tokyo Medical and Dental University Number of participants/teeth/sites: 53 participants, 91 surfaces Prevalence: enamel 0.67, 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: 6 dentists, with training session for calibration Threshold applied: sound, superficial demineralisation of enamel, enamel breakdown due to the caries, dentine caries Device specifics: "Dental OCT System (Prototype 2, Panasonic Healthcare Co Ltd, Ehime, Japan) used in the present study"; "high‐speed frequency swept laser light with a center wavelength of 1330 nm was projected onto the occlusal surface"
Target condition and reference standard(s)	Category: clinical visual evaluation ‐ excavation of severe caries, the remainder were based on a visual examination (no separation of teeth but only those that could be viewed were included) Sequence of index test and reference standard: index test prior to reference standard Training of examiner: not reported Blinding to index test: not possible Multiple tests: yes, visual plus excavation Site selection: approximal surface under investigation Target condition: no caries, enamel, or dentine
Flow and timing	Participants with index test but no reference standard: 5 excluded from results since the approximal surface could not be viewed Participants with reference standard but no index test: 0 Time interval between tests: unclear 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?			Low concern
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)?
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?	No
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?		High 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?	Unclear
Did all patients receive the same reference standard?	No
Were all patients included in the analysis?	No
Could the patient flow have introduced bias?		High risk