Bizhang 2016.

Study characteristics
Patient Sampling	Method of sampling: consecutive Included conditions: no cavitation and early lesions Teeth: permanent molars Sealants: not reported Surface: approximal
Patient characteristics and setting	Age: 18 to 65 years, mean 26.7 Sex: not reported Ethnicity: not reported Country: Germany Setting: in vivo with recruited patients but setting unclear Number of participants/teeth/sites: 20 teeth/341 surfaces Prevalence: not reported
Index tests	Category of test: DIAGNOdent pen Sequence of test(s): index tests (visual, radiograph, then DIAGNOdent pen) where radiograph is the reference standard Examiner training and calibration: calibrated dentist Teeth cleaning prior to examination: oral prophylaxis and floss Tooth drying prior to examination: 5 seconds compressed air Threshold applied: > 16 dentine Device specifics: not reported
Target condition and reference standard(s)	Category: radiograph Sequence of index test and reference standard: radiographs performed at screening session, then again 1 week later Training of examiner: not reported Blinding to index test: unclear Multiple tests: no Site selection: all approximal surfaces Target condition: sound, initial enamel, advanced enamel, intial dentine, advanced 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: one week 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?	Yes
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Yes
Could the selection of patients have introduced bias?		Low risk
Are there concerns that the included patients and setting do not match the review question?			Unclear
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)
DOMAIN 2: Index Test (Red 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 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?	Unclear
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