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

Diniz 2019.

Study characteristics
Patient Sampling Method of sampling: unclear
Included conditions: unclear on severity of lesions "with varying conditions from sound to that of different stages of carious lesion"
Teeth: primary molars
Sealants: excluded
Surface: occlusal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Brazil
Setting: extracted teeth
Number of participants/teeth/sites: 88 teeth
Prevalence: enamel 0.74, dentine 0.63
Index tests Category of test: DIAGNOdent, DIAGNOdent pen, QLF (QLF Inspektor Pro; Inspektor Research System, Amsterdam, Netherlands), and Midwest
Sequence of test(s): index tests (visual, DIAGNOdent, DIAGNOdent pen, QLF, and MidWest) followed by reference standard
Examiner training and calibration: 1 trained and experienced examiner
Teeth cleaning prior to examination: rinsed with 3in1 syringe
Tooth drying prior to examination: dried for DIAGNOdent, DIAGNOdent pen and QLF; but kept moist for Midwest
Threshold applied: calculated within study for DIAGNOdent, DIAGNOdent pen, and QLF
DIAGNOdent: 0–4 sound, 5‐23 enamel, 24+ dentine
DIAGNOdent pen: 0–3 sound, 4–19 enamel, 20+ dentine
Midwest: green light/no beep ‐ sound, red light slow/moderate beep ‐ enamel, red light/fast beep ‐ 3+ dentine
QLF: 0‐7.4 sound, 7.5‐13.8 enamel, 13.9+ dentine
Device specifics: using Inspektor Pro Software parameter ΔF (percentage of green fluorescence radiance loss) was recorded
Target condition and reference standard(s) Category: histology
Sequence of index test and reference standard: index test then reference standard
Training of examiner: not reported
Blinding to index test: unclear
Multiple tests: no
Site selection: marked on photographs then sectioned teeth
Target condition: sound, inner/outer enamel, inner/outer 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? 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? 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)
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? 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 (Blue fluorescence)
DOMAIN 2: Index Test (Red fluorescence)
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? Unclear    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Unclear 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