Almosa 2014.

Study characteristics
Patient Sampling	Method of sampling: consecutive Included conditions: no cavitation and enamel lesions Teeth: permanent premolars and anterior ‐ buccal Sealants: unclear Surface: smooth
Patient characteristics and setting	Age: mean 22.5 years Sex: 33 male, 56 female Ethnicity: not reported Country: Saudi Arabia Setting: governmental and private orthodontic clinics Number of participants/teeth/sites: 89/822/1653 Prevalence: enamel 0.33, dentine 0.01
Index tests	Category of test: DIAGNOdent pen Sequence of test(s): visual and DIAGNOdent pen conducted consecutively Examiner training and calibration: training workshop attended Teeth cleaning prior to examination: cleaned with rubber cup, pumice paste, and floss Tooth drying prior to examination: dried with compressed air Threshold applied: 0‐13 sound, 14‐20 enamel (outer), 21‐29 enamel (deep), > 30 dentinal Device specifics: flat tip
Target condition and reference standard(s)	Category: visual (ICDAS) Sequence of index test and reference standard: consecutively with index test Training of examiner: training workshop Blinding to index test: no Multiple tests: no Site selection: unclear Target condition: sound = ICDAS 0, enamel = ICDAS 1 and 2, deep enamel = ICDAS 3 and 4, dentine = ICDAS 5 and 6
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	Reference standard classify ICDAS 3 and 4 as enamel caries which conflicts other definitions
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?			Low concern
DOMAIN 2: Index Test (All)
Were the index test results interpreted without knowledge of the results of the reference standard?	Unclear
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?	Unclear
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?			High
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