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

Diniz 2009.

Study characteristics
Patient Sampling Method of sampling: selected "from sound to different degrees of non‐cavitated caries lesions"
Included conditions: no cavitation and early lesions
Teeth: permanent first molars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: 7 to 12 years
Sex: not reported
Ethnicity: not reported
Country: Brazil
Setting: extracted teeth
Number of participants/teeth/sites: 35 participants/130 teeth
Prevalence: enamel 0.89, dentine 0.67
Index tests Category of test: DIAGNOdent
Sequence of test(s): index tests (visual then DIAGNOdent) followed by reference standard
Examiner training and calibration: experienced and trained
Teeth cleaning prior to examination: pumice slurry and water
Tooth drying prior to examination: air dried
Threshold applied: 0‐14 sound, 15‐21 enamel, 22+ dentine
Device specifics: not reported
Note: different examiners for visual, DIAGNOdent, and reference standard
Target condition and reference standard(s) Category: radiograph and visual (third dentist), excavation where appropriate
Sequence of index test and reference standard: index test then reference standard
Training of examiner: experienced
Blinding to index test: yes
Multiple tests: combined test
Site selection: teeth were drawn to aid examiners
Target condition: sound, inner/outer enamel, inner/outer 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 Cannot extract data at the enamel threshold so no included in meta‐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?     High
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? Yes    
If multiple tests were applied were different examiners used for each (in vivo)? Yes    
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? Yes    
If a threshold was used, was it pre‐specified? Yes    
If multiple tests were applied were different examiners used for each (in vivo)? Yes    
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? 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?     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