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

Kuhnisch 2007.

Study characteristics
Patient Sampling Method of sampling: selected, participants already part of ongoing longitudinal study and consented to this additional study after a clinical investigation
Included conditions: unclear caries status of participants
Teeth: permanent premolars and molars
Sealants: yes
Surface: occlusal
Patient characteristics and setting Age: 14 to 15 years
Sex: not reported
Ethnicity: not reported
Country: Erfurt, Germany
Setting: school based
Number of participants/teeth/sites: 34 participants, 517/311 surfaces/teeth
Prevalence: not clearly reported
Index tests Category of test: QLF Inspektor
Sequence of test(s): visual (reference standard) completed prior to index test but examiner independent
Examiner training and calibration: "two calibrated investigators"
Teeth cleaning prior to examination: unclear
Tooth drying prior to examination: 5 seconds air drying
Threshold applied: not clearly reported
Device specifics: QLF 2.00f software was used to display, score and analyse the images
Target condition and reference standard(s) Category: visual
Sequence of index test and reference standard: index test followed the reference standard
Training of examiner: experienced examiners
Blinding to index test: yes, clearly stated
Multiple tests: no
Site selection: occlusal surfaces
Target condition: Ekstrand scores: white opacities, brown discolourations, enamel breakdown and dentine exposure
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: 206
Comparative  
Notes Cannot use data, not possible to extract a 2x2 table
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?     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? Unclear    
If multiple tests were applied were different examiners used for each (in vivo)?      
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)
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? Unclear    
If multiple tests were applied were different examiners used for each (in vivo)?      
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 (Blue fluorescence)
DOMAIN 2: Index Test (Red fluorescence)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? No    
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?   High 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?   High risk