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

Mendes 2012.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: non‐cavitated and enamel lesions
Teeth: primary molars
Sealants: unclear
Surface: occlusal and approximal
Patient characteristics and setting Age: 4 to 12 years, mean 7.3
Sex: occlusal ‐ 30 male, 38 female; approximal ‐ 53 male, 73 female
Ethnicity: not reported
Country: Brazil
Setting: dental hospital
Number of participants/teeth/sites: occlusal ‐ 68 participants/407 sites; proximal ‐ 132 participants/1213 sites
Prevalence: occlusal ‐ dentine 0.05; proximal ‐ 0.04
Index tests Category of test: DIAGNOdent
Sequence of test(s): visual, then radiograph, then DIAGNOdent
Examiner training and calibration: not reported
Teeth cleaning prior to examination: brush, pumice and slurry
Tooth drying prior to examination: 5 seconds
Threshold applied: occlusal: > 34 dentine; approximal: > 16
Device specifics: tip 2 was used for occlusal surfaces; tip 1 was used for approximal surfaces
Target condition and reference standard(s) Category:
occlusal ‐ excavation of those teeth suspected of dentinal caries (ICDAS score of 6 3), the remainder received visual assessment only
approximal ‐ "temporary separation using orthodontic rubber rings placed around the contact points for 7 days. Two examiners evaluated each surface for the presence of cavities"
Sequence of index test and reference standard: index test then reference standard
Training of examiner: not reported
Blinding to index test: not reported
Multiple tests: yes
Site selection: photographed and site selected
Target condition: cavitated caries lesions; "the cut‐off point for visual inspection was an ICDAS score of 3"
Flow and timing Participants with index test but no reference standard: occlusal: unclear, approximal: 6
Participants with reference standard but no index test: 0
Time interval between tests: occlusal ‐ unclear, approximal ‐ 1 week
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? No    
If a threshold was used, was it pre‐specified? Yes    
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?   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)
DOMAIN 2: Index Test (Red fluorescence)
Were the index test results interpreted without knowledge of the results of the reference standard? No    
If a threshold was used, was it pre‐specified? Yes    
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?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
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? No    
Could the patient flow have introduced bias?   High risk