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

Pinelli 2002.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: no cavitation and early lesions, "none of the teeth showed macroscopic signs of cavity formation with exposure into dentin"
Teeth: permanent molars, "the inclusion criterion was the presence of at least one white‐spot caries lesion on a free smooth surface"
Sealants: not reported
Surface: "free smooth surfaces"
Patient characteristics and setting Age: 11 to 17 years
Sex: not reported
Ethnicity: not reported
Country: Brazil
Setting: school, "The examinations were carried out in classrooms under good light conditions"
Number of participants/teeth/sites: 50 participants/220 surfaces
Prevalence: enamel 0.50
Index tests Category of test: DIAGNOdent
Sequence of test(s): visual then DIAGNOdent
Examiner training and calibration: yes
Teeth cleaning prior to examination: floss and brush
Tooth drying prior to examination: air dried, 10 seconds
Threshold applied: 0‐4 arrested, 5+ active
Device specifics: "DIAGNOdent was used to examine only the lesions detected by visual inspection"
Target condition and reference standard(s) Category: visual
Sequence of index test and reference standard: reference standard performed before index test
Training of examiner: calibration completed
Blinding to index test: yes
Multiple tests: no
Site selection: those identified visually
Target condition: active or inactive lesions
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: 1 week to allow for separation of teeth
Participants receiving both tests but excluded from results: 0
Comparative  
Notes Inclusion criteria suggests sound teeth were excluded, but the results confirm that sound teeth were present in the sample
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? 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? No    
If a threshold was used, was it pre‐specified? Yes    
If multiple tests were applied were different examiners used for each (in vivo)? Unclear    
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