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

Bozdemir 2013.

Study characteristics
Patient Sampling Method of sampling: unclear
Included conditions: no cavitation and early lesions
Teeth: permanent molars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: 20 to 25 years, mean 20.2
Sex: 7 male, 30 female
Ethnicity: not reported
Country: Turkey
Setting: dental school
Number of participants/teeth/sites: 37 teeth/156 surfaces
Prevalence: not reported, only those suspected of caries received reference standard so data do not reflect full sample
Index tests Category of test: DIAGNOdent pen and Midwest
Sequence of test(s): index tests performed prior to reference standard, same 2 examiners completed all tests
Examiner training and calibration: "previously trained"
Teeth cleaning prior to examination: rubber cup and paste
Tooth drying prior to examination: air dried for 3 seconds
Threshold applied:
DIAGNOdent pen: 0–13 healthy, 14–20 enamel, 21–29 superficial dentine, > 30 deep dentine
Midwest: no signal/green light ‐ healthy, slow signal/red light ‐ enamel, medium signal/red light ‐ superficial dentine, rapid or continuous signal/red light ‐ deep dentine
Device specifics: DIAGNOdent pen ‐ cone shaped tip
Target condition and reference standard(s) Category: excavation ‐ only those diagnosed as having caries by index tests were investigated
Sequence of index test and reference standard: index test then reference standard
Training of examiner: not reported
Blinding to index test: yes
Multiple tests: no
Site selection: complete occlusal fissure
Target condition: sound, enamel (outer), enamel (inner), dentine (outer), dentine (inner)
Flow and timing Participants with index test but no reference standard: 30
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 not used because 156 sites were included but only 126 were opened
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? Yes    
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?     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? Yes    
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?   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? Yes    
If a threshold was used, was it pre‐specified? Yes    
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?   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? No    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   High risk