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

Lee 2018.

Study characteristics
Patient Sampling Method of sampling: "selected from a pool of extracted human teeth having questionable caries"
Included conditions: questionable caries
Teeth: permanent premolars and molars
Sealants: not reported
Surface: occlusal
Patient characteristics and setting Age: 20 years or older
Sex: not reported
Ethnicity: not reported
Country: South Korea
Setting: extracted teeth
Number of participants/teeth/sites: 66 teeth (4 were broken during sectioning)
Prevalence: 0.81 enamel, 0.11 dentine
Index tests Category of test: QLF–Digital Biluminator™ 2+, decrease in fluorescence (ΔF) and the increase in red fluorescence (ΔR) are both reported
Sequence of test(s): index test (QLF) followed by reference standard
Examiner training and calibration: not reported
Teeth cleaning prior to examination: calculus and soft tissue removed with scaler
Tooth drying prior to examination: not reported
Threshold applied: optimum thresholds calculated in study: ΔF sound 62, enamel 82, dentine 93
Device specifics: "an analysis patch was delimited by drawing a border that pointed at sound parts without discolorations from the stained pits and fissures with suspected caries according to manufacturer recommendations using the QLF‐D software"
Target condition and reference standard(s) Category: histology
Sequence of index test and reference standard: index tests then reference standard
Training of examiner: not reported
Blinding to index test: not reported
Multiple tests: no
Site selection: sectioned teeth
Target condition: "no enamel demineralization or a narrow surface zone of opacity (scored as 0), enamel demineralization limited to the outer 50% of the enamel layer (scored as 1), demineralization involving the inner 50% of enamel up to the DEJ (scored as 2), and demineralization involving the outer 50% of the dentine (scored as 3)"
Flow and timing Participants with index test but no reference standard: 4 ‐ reported that these were broken during sectioning
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 Data reported for the decrease in fluorescence (ΔF)
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? Unclear    
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?     Low concern
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)? Unclear    
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)
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)? Unclear    
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 (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? 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