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

Rocha 2003.

Study characteristics
Patient Sampling Method of sampling: selected, "Fifty occlusal sites were selected for this study"
Included conditions: no cavitation and early lesions
Teeth: primary molars
Sealants: excluded
Surface: occlusal
Patient characteristics and setting Age: 10 to 11 years
Sex: not reported
Ethnicity: not reported
Country: Brazil
Setting: children with teeth close to exfoliation
Number of participants/teeth/sites: 29 participants/50 sites
Prevalence: enamel 0.58, dentine 0.14
Index tests Category of test: DIAGNOdent
Sequence of test(s): DIAGNOdent, visual, radiograph followed by reference standard
Examiner training and calibration: previously trained
Teeth cleaning prior to examination: "professionally cleaned"
Tooth drying prior to examination: 5 seconds with dried air
Threshold applied: "The cutoff limits for all and dentin lesions were values of 6 and 21"
Device specifics: tip A, marked on photograph, then maximum value, mean of 3 measurements
Target condition and reference standard(s) Category: histology
Sequence of index test and reference standard: index test conducted before reference standard
Training of examiner: not reported
Blinding to index test: yes
Multiple tests: no
Site selection: sectioned tooth
Target condition: sound, outer enamel, inner enamel and first third dentine middle and inner 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? 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? Yes    
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?   Low 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