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

Jablonski‐Momeni 2016.

Study characteristics
Patient Sampling Method of sampling: unclear
Included conditions: non‐cavitated and early lesions (ICDAS 0‐2)
Teeth: primary (this entry is for primary) and permanent
Sealants: not reported
Surface: occlusal
Patient characteristics and setting Age: 5 to 12 years, mean age 9.1
Sex: 17 male, 18 female
Ethnicity: not reported
Country: Germany
Setting: "recruited in a dental office"
Number of participants/teeth/sites: 35 participants/205 primary, 214 permanent teeth
Prevalence:
primary: enamel 0.18, dentine 0
permanent: enamel 0.35, dentine 0
Index tests Category of test: VistaProof
Sequence of test(s): visual prior to VistaProof, so reference standard then index test
Examiner training and calibration: not reported
Teeth cleaning prior to examination: yes, rotating brush and paste, then rinsed with a 3 in 1 syringe
Tooth drying prior to examination: unclear
Threshold applied: 0–1.2 sound; 1.3–1.5 enamel caries; > 1.5 dentine caries
Device specifics: "Each image was analyzed by the specific software (DBSWIN, Durr Dental)"
Target condition and reference standard(s) Category: visual (ICDAS) for all surfaces
Sequence of index test and reference standard: the index test was performed after visual examination
Training of examiner: unclear
Blinding to index test: not reported
Multiple tests: no
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: 13, "Thirteen teeth were unable to be monitored for 1 year (due to restorative treatment or extraction)"
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?     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?   Unclear 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?   Unclear 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? 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?     High
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?   Low risk