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

Kuhnisch 2006.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: non‐cavitated and early lesions
Teeth: permanent third molars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Germany
Setting: extracted teeth
Number of participants/teeth/sites: 54 teeth
Prevalence: histology results not clearly reported
Index tests Category of test: QLF Inspektor
Sequence of test(s): index test then reference standard
Examiner training and calibration: trained by manufacturer
Teeth cleaning prior to examination: brush and polish
Tooth drying prior to examination: compressed air
Threshold applied: calculated in study using DF, area, and DQ
Device specifics: 3 examiners reached agreement in software image
Target condition and reference standard(s) Category: histology ‐ visual and radiograph of sections
Sequence of index test and reference standard: index tests then reference standard
Training of examiner: not reported
Blinding to index test: same examiner
Multiple tests: yes
Site selection: sectioned teeth
Target condition: sound, outer half of enamel, inner half of enamel, outer half of dentine, deep 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  
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)
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 (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? No    
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