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

Jablonski‐Momeni 2014.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: not clearly stated in the recruitment section, results report acceptable level of dentinal lesions
Teeth: permanent molars and premolars
Sealants: not reported
Surface: occlusal
Patient characteristics and setting Age: minimum age of 18 years, mean 27.4
Sex: 10 male, 16 female
Ethnicity: not reported
Country: Germany
Setting: assumed to be a clinical setting as the aim was to determine which surfaces should be restored
Number of participants/teeth/sites: 26 teeth/306 sites
Prevalence: enamel 0.17, dentine 0.12
Index tests Category of test: VistaProof
Sequence of test(s): unclear on the sequence of tests, reported as visual first then VistaProof followed by radiograph and excavation where propriae
Examiner training and calibration: 2 trained examiners
Teeth cleaning prior to examination: yes, cleaned and air‐dried using a triplex syringe
Tooth drying prior to examination: as above
Threshold applied: 0–0.9 sound; 1.0–1.4 early stage of enamel lesion; 1.5–1.9 deep enamel lesion; 2.0–2.4 dentine caries; and > 2.4 deep dentine caries
Device specifics: specific software used for analysis, "Sound enamel and carious lesions are visualised in colour and numerically (on a scale from 0 to 4)"
Target condition and reference standard(s) Category: visual (ICDAS) for all surfaces, where appropriate radiographs and excavation where applied
Sequence of index test and reference standard: it seems the index test was performed after visual examination and before radiographs, so index may have influenced decision
Training of examiner: 1 experienced examiner
Blinding to index test: no
Multiple tests: yes
Site selection: all selected occlusal surfaces
Target condition: ICDAS categories: 0 = sound; 1 = first visible sign of non‐cavitated lesion seen only when the tooth is dry; 2 = visible non‐cavitated lesion seen when wet and dry; 3 = microcavitation in enamel; code 4 = non‐cavitated lesion extending into dentine seen as an undermining shadow; code 5 = small cavitated lesion with visible dentine: less than 50% of surface; and code 6 = large cavitated lesion with visible 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? Unclear    
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)
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
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 (Red fluorescence)
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? No    
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? Yes    
Could the patient flow have introduced bias?   High risk