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. 2020 Dec 8;2020(12):CD013811. doi: 10.1002/14651858.CD013811

Diniz 2011.

Study characteristics
Patient Sampling Method of sampling: selected "sound to carious were selected from a pool of extracted teeth" so unclear the level of cavity included
Included conditions: no cavitation and early lesions
Teeth: permanent third molars
Sealants: not reported
Surface: occlusal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Brazil
Setting: extracted teeth
Number of participants/teeth/sites: 55 teeth
Prevalence: enamel 0.89, dentine 0.11
Index tests Category of test: DIAGNOdent, DIAGNOdent pen and VistaProof
Sequence of test(s): index tests (visual inspected but not assessed then fluorescence devices) followed by reference standard
Examiner training and calibration: 2 experienced examiners
Teeth cleaning prior to examination: prophylactic paste using a slow‐rotating contra angle handpiece with a Robinson brush (group 2)
Tooth drying prior to examination: dried for 3 seconds
Threshold applied: calculated within study
DIAGNOdent: 0–15 sound, 16–25 enamel, 25+ dentine
DIAGNOdent pen: 0–10 sound, 11–34 enamel, 34+ dentine
VistaProof: 0–1.1 sound, 1.2–1.7 enamel, 1.7+ dentine
Device specifics: VistaProof ‐ specific software (DBSWIN) that translates the rates of red and green fluorescence into numbers corresponding to lesion severity
Target condition and reference standard(s) Category: histology
Sequence of index test and reference standard: index test then reference standard
Training of examiner: 2 trained examiners
Blinding to index test: unclear
Multiple tests: no
Site selection: marked on photographs then sectioned teeth
Target condition: sound, inner/outer enamel, inner/outer 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: minimal
Participants receiving both tests but excluded from results: 0
Comparative  
Notes Results used from stage (2) after professional prophylaxis (prophylactic paste) for 10 seconds, rinsing for 3 seconds and drying for 3 seconds
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? No    
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?     Low concern
DOMAIN 2: Index Test (Green fluorescence)
DOMAIN 2: Index Test (Blue 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? No    
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?     Low concern
DOMAIN 2: Index Test (Red fluorescence)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
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?   Low 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