Mansour 2016.

Study characteristics
Patient Sampling	Method of sampling: unclear Included conditions: no cavitation and early cavitation; "Subjects with open cavities extending into dentin were excluded" Teeth: permanent molars Sealants: not reported Surface: "all coronal areas of the teeth considered to be at high risk of caries: occlusal and approximal, white or brown spot lesions, non‐cavitated and cavitated potential lesions, fissures, and adjacent to restorations"
Patient characteristics and setting	Age: 19 to 52 years, mean 34 Sex: 16 male, 24 female Ethnicity: not reported Country: USA Setting: dental clinic Number of participants/teeth/sites: 40 participants, 932 teeth (426 untreated teeth used in this sample) Prevalence: untreated teeth: enamel 0.12; previously treated: enamel 0.14
Index tests	Category of test: prototype SS‐OCT system Sequence of test(s): index tests (laser fluorescence also completed and potentially interpreted by same examiner) performed after reference standard Examiner training and calibration: 90‐minute training session ‐ "Two blinded, pre‐standardized examiners reviewed radiographic and OCT images independently" Threshold applied: examiner assessed; "OCT images independently and assigned caries status as either healthy or carious" Device specifics: "used in this study utilizes a broadband light source with an output power of 4 mW at the center wavelength of λ = 1310 nm and bandwidth of Δλ = 58 nm" Note: applicability concerns due to device being a prototype model which is not commercially available
Target condition and reference standard(s)	Category: visual and radiograph; "detailed dental examination by one experienced clinician using loupes (2.5 magnification), and radiographs according to standard clinical practice" Sequence of index test and reference standard: index test followed reference standard Training of examiner: 90‐minute training session Blinding to index test: yes, reference standard before index tests Multiple tests: yes Site selection: clinical examination Target condition: "Teeth were considered carious if there were white or brown spot lesions on the tooth not consistent with the clinical appearance of sound enamel"; 'healthy' being scored if both observers scored 'healthy', and 'not‐healthy' scored if 1 or both observers scored 'not‐healthy'
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	Untreated teeth used in the data extraction for analysis
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Unclear
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Yes
Could the selection of patients have introduced bias?		Unclear 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)?	No
Could the conduct or interpretation of the index test have introduced bias?		High risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			High
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?	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