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

Krause 2007.

Study characteristics
Patient Sampling Method of sampling: selected "non‐cavitated occlusal carious lesions requiring operative intervention (score 3) or teeth where no or preventive treatment was indicated by visual examination and/or bitewing radiographs (scores 0, 1, or 2) were selected"
Included conditions: no cavitation or early lesions
Teeth: permanent premolars and molars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: mean 36 (+‐ 8 years)
Sex: 34 male, 48 female
Ethnicity: not reported
Country: Germany
Setting: unclear
Number of participants/teeth/sites: 82 participants/94 teeth
Prevalence: enamel not reported, dentine 0.51
Index tests Category of test: DIAGNOdent and DIAGNOdent pen
Sequence of test(s): visual and radiograph (these determined whether excavation was necessary) then DIAGNOdent/pen
Examiner training and calibration: not reported
Teeth cleaning prior to examination: "professional cleaning of the occlusal surfaces using a rotating soft rubber cup and plain water spray"
Tooth drying prior to examination: briefly drying the teeth with air pressure
Threshold applied: calculated in study for dentine level only
Device specifics: tip specifics not reported
Target condition and reference standard(s) Category: excavation of those lesions identified through visual and radiograph tests
Sequence of index test and reference standard: reference standard then index tests
Training of examiner: not reported
Blinding to index test: not reported
Multiple tests: no
Site selection: occlusal surface
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: 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?     Low concern
DOMAIN 2: Index Test (All)
Were the index test results interpreted without knowledge of the results of the reference standard? No    
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)
DOMAIN 2: Index Test (Blue fluorescence)
DOMAIN 2: Index Test (Red fluorescence)
Were the index test results interpreted without knowledge of the results of the reference standard? No    
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 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? Unclear    
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? No    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   High risk