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

Muller‐Bolla 2017.

Study characteristics
Patient Sampling Method of sampling: unclear how participants were identified
Included conditions: enamel lesions, possibly cavitated, "Caries‐free subjects (without carious lesions diagnosed by both visual examination and bitewing radiographs) or uncooperative children during the examination were excluded"
Teeth: primary and permanent, premolars and molars
Sealants: unclear
Surface: occlusal
Patient characteristics and setting Age: 5 to 15 years
Sex: 60% male
Ethnicity: not reported
Country: France
Setting: university hospital, attending paediatric clinic
Number of participants/teeth/sites: 103 participants/743 sites
Prevalence: enamel 0.72, dentine 0.29
Index tests Category of test: DIAGNOdent pen and Soprolife
Sequence of test(s): visual and radiograph (reference standard) followed by Soprolife and DIAGNOdent pen
Examiner training and calibration: 1 day calibration session
Teeth cleaning prior to examination: sodium bicarbonate powder‐cleaning tool was used for 5 to 10 seconds per tooth
Tooth drying prior to examination: not reported
Threshold applied:
Soprolife: sound ‐ shiny green, outer enamel ‐ tiny, thin red or grey shimmer in the pits and fissure, inner enamel ‐ red shimmer, grey or black colouration in the pits and fissure, dentine ‐ red areas wider than fissures; surface roughness occurs, possibly grey or rough grey zone visible
DIAGNOdent pen: 0‐12 sound, 13‐24 enamel, 25+ dentine
Device specifics: fibre tip for DIAGNOdent pen, Soprolife ‐ "studied using the SoproImaging software"
Target condition and reference standard(s) Category: visual (ICDAS) and radiograph
Sequence of index test and reference standard: reference standard before Soprolife and DIAGNOdent pen
Training of examiner: experienced examiners with 1 day training
Blinding to index test: yes
Multiple tests: yes
Site selection: full surface assessed
Target condition: ICDAS 1 to 6
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 Prevalence of caries for primary and permanent dentition unknown so have to use the mixed dentition results
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? No    
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? No    
If a threshold was used, was it pre‐specified? Yes    
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?     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? No    
If a threshold was used, was it pre‐specified? Yes    
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?     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?     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? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk