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

Ferreira 1998.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: no cavitation and early lesions
Teeth: permanent premolars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: USA
Setting: extracted teeth
Number of participants/teeth/sites: 150 teeth
Prevalence: not reported
Index tests Category of test: bespoke LF device, combined with dye enhancement
Sequence of test(s): index tests (visual and LF) followed by reference standard
Examiner training and calibration: unclear
Teeth cleaning prior to examination: yes
Tooth drying prior to examination: 5 seconds
Threshold applied: colour assessed by 2 examiners
Device specifics: not relevant as unique device
Target condition and reference standard(s) Category: histology
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: marked on teeth
Target condition: yes or no if decalcification present or not
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?     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)? Unclear    
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)
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?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 2: Index Test (Blue fluorescence)
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?     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