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

Kuhnisch 2008.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: unclear on exact level of severity to be included in sample
Teeth: primary and permanent molars
Sealants: yes ‐ labelled where present
Surface: occlusal
Patient characteristics and setting Age: 8 to 12 years
Sex: not reported
Ethnicity: not reported
Country: Germany
Setting: primary school
Number of participants/teeth/sites: 311 participants/840 occlusal sites
Prevalence: 0.71 enamel, 0.06 dentine (ICDAS 4 and above)
Index tests Category of test: DIAGNOdent
Sequence of test(s): reference standard then index test
Examiner training and calibration: calibrated
Teeth cleaning prior to examination: yes but technique not described
Tooth drying prior to examination: 5 seconds air drying
Threshold applied: 0‐15 sound, 16‐17 enamel, 18‐31 dentine, 31 deep dentine
Device specifics: conical probe A
Target condition and reference standard(s) Category: visual (ICDAS)
Sequence of index test and reference standard: reference standard before index test
Training of examiner: calibrated before study
Blinding to index test: yes
Multiple tests: no
Site selection: all occlusal surfaces
Target condition: ICDAS
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? Unclear    
If a threshold was used, was it pre‐specified? Yes    
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?   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)
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? Unclear    
If a threshold was used, was it pre‐specified? Yes    
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?   Low 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? 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? Yes    
Could the patient flow have introduced bias?   Low risk