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

Bahrololoomi 2015.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: no cavitation and early lesions "intact or had incipient and inconspicuous caries with or without colour change were selected"
Teeth: permanent molars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: 7 to 13 years
Sex: not reported
Ethnicity: not reported
Country: Iran
Setting: dental school
Number of participants/teeth/sites: 31 participants/115 teeth (6 of these were excluded "due to patient dropout" so they became 109 teeth)
Prevalence: enamel 0.94, dentine 0.37
Index tests Category of test: DIAGNOdent
Sequence of test(s): index tests (visual, radiograph, DIAGNOdent) performed prior to reference standard
Examiner training and calibration: not reported
Teeth cleaning prior to examination: cleaning with a rubber cup and pumice powder
Tooth drying prior to examination: isolation with cotton rolls, and drying
Threshold applied: defined in study: 0‐7 sound, 8‐10 enamel, 11+ dentine
Device specifics: not reported
Target condition and reference standard(s) Category: excavation ‐ in cases with obvious or ambiguous caries
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: excavated suspicious site
Target condition: sound, enamel, dentine
Flow and timing Participants with index test but no reference standard: unclear whether all surfaces were excavated and if not then what the reference standard was
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 Examiner 2 results used for analysis
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? 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?     Unclear
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? 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?     Unclear
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? Unclear    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   High risk