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

Jablonski‐Momeni 2012a.

Study characteristics
Patient Sampling Method of sampling: unclear
Included conditions: no cavitation and early lesions
Teeth: permanent premolars and molars
Sealants: not reported
Surface: occlusal; "permanent posterior teeth without occlusal restorations"
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Germany
Setting: extracted teeth
Number of participants/teeth/sites: 36 teeth/82 sites
Prevalence: enamel 0.84, dentine 0.48
Index tests Category of test: DIAGNOdent and VistaCam iX (using fluorescence)
Sequence of test(s): index tests (visual then DIAGNOdent and VistaCam) performed prior to reference standard
Examiner training and calibration: 2 examiners, "doctoral student calibrated by an experienced investigator"
Teeth cleaning prior to examination: yes, method not reported
Tooth drying prior to examination: not reported
Threshold applied:
DIAGNOdent: 0‐7 sound; 8‐24 enamel caries; > 25 dentine caries
VistaCam: 0.0‐0.9 sound; 0.9‐2.0 enamel; > 2.0 dentine caries (manufacturers thresholds)
Device specifics:
DIAGNOdent pen: tip A
VistaProof: long‐distance spacer
Target condition and reference standard(s) Category: excavation
Sequence of index test and reference standard: index test then reference standard
Training of examiner: not reported
Blinding to index test: unclear
Multiple tests: no
Site selection: all teeth opened with rotating instrument
Target condition: sound, enamel, dentine
Flow and timing Participants with index test but no reference standard: 0
Participants with reference standard but no index test: 4, "While using the FC device, 4 investigation sites could not be assessed due to technical problems"
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? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
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?     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)? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Unclear 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? Yes    
If multiple tests were applied were different examiners used for each (in vivo)? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Unclear 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? Yes    
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? No    
Could the patient flow have introduced bias?   Low risk