Bussaneli 2015a.

Study characteristics
Patient Sampling	Method of sampling: selected Included conditions: no cavitation and early lesions "sound or carious primary molars in proximal contact", exclusions "Teeth with restoration, occlusal caries, hypoplasias, and an advanced stage of rhizolysis were not included" Teeth: primary molars Sealants: not reported Surface: approximal
Patient characteristics and setting	Age: 5 to 9 years Sex: not reported Ethnicity: not reported Country: Brazil Setting: extracted teeth Number of participants/teeth/sites: 45 participants/59 teeth Prevalence: enamel 0.71, dentine 0.58
Index tests	Category of test: DIAGNOdent pen Sequence of test(s): index tests (visual, DIAGNOdent pen, radiograph) prior to reference standard Examiner training and calibration: experienced Teeth cleaning prior to examination: brush at low speed, using prophylactic paste and dental floss Tooth drying prior to examination: unclear Threshold applied: 0‐14 sound, 15‐21 enamel, 22‐37 outer dentine, 38+ inner dentine Device specifics: tip 1
Target condition and reference standard(s)	Category: visual after separation using orthodontic rubber bands (4 mm) for 7 days Sequence of index test and reference standard: index test then reference standard Training of examiner: 2 trained and experienced examiners Blinding to index test: unclear Multiple tests: no Site selection: all approximal surfaces Target condition: healthy, active lesions without loss of structure, signs of caries requiring restoration
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?	Yes
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)
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?			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