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. 2021 Jan 27;2021(1):CD013855. doi: 10.1002/14651858.CD013855

Bussaneli 2015.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: sound and early lesions; "One hundred and two permanent healthy or decayed human teeth (molars and premolars) were obtained and cleaned"
Teeth: permanent premolars and molars
Sealants: not reported
Restorations: not reported
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: 102 teeth
Prevalence: enamel 0.70, dentine 0.19
Index tests Category of test: near‐infrared laser transillumination
Sequence of test(s): index tests (radiograph, near‐infrared then DIAGNOdent pen and QLF) prior to reference standard; each index test separated by 1 week
Examiner training and calibration: experienced, blinding of tests due to time gap between assessments of each index test
Threshold applied: "measurements were used to calculate the contrast intensities"
Device specifics: "A prototype manufactured by DMC Equipamentos (São Carlos, Brazil) was used"
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: sectioned teeth
Target condition: healthy, enamel, lesion at the dentine‐enamel junction or dentinal
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: 8 teeth excluded from results as near‐infrared device failed to return a result, therefore excluded from all tests
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? Unclear    
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?     High
DOMAIN 2: Index Test (All tests)
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? Unclear    
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?   Unclear risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     High
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? No    
Could the patient flow have introduced bias?   High risk