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

Zeitouny 2014.

Study characteristics
Patient Sampling Method of sampling: random
Included conditions: no cavitation and early lesions
Teeth: permanent molars and premolars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: 15 to 65 years
Sex: 11 male, 10 female
Ethnicity: not reported
Country: Lebanon
Setting: dental school
Number of participants/teeth/sites: 219 teeth
Prevalence: enamel 0.74, dentine 0.14 (according to examiner 1)
Index tests Category of test: Soprolife camera
Sequence of test(s): visual (reference standard) before Soprolife
Examiner training and calibration: calibrated
Teeth cleaning prior to examination: waterjet and bicarbonate of soda
Tooth drying prior to examination: air syringe dried for 5 seconds
Threshold applied: codes 0‐5: code 0 was given when the fissure appears shiny green, the enamel appears sound, and there are no visible changes; code 1 was selected if a tiny, thin red shimmer in the pits and fissure system is observed, which can slightly come up the slopes (walls) of the fissure system. No red dots appeared; code 2 darker red spots confined to the fissure are visible; code 3 dark red spots have extended as lines into the fissure areas but remain confined to the fissures. A slight beginning roughness of the more lined red areas can be visible; code 4 if the dark red (or red‐orange) extends wider than the confines of the fissures; code 5 was selected if obvious openings of enamel were seen with visible dentine
Device specifics: blue mode was used, Sopro imaging software was used for analysis
Target condition and reference standard(s) Category: visual
Sequence of index test and reference standard: reference standard before index test
Training of examiner: trained prior to study
Blinding to index test: no
Multiple tests: no
Site selection: unclear
Target condition: ICDAS
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: 55 (see notes below)
Comparative  
Notes Results reported for "the noncarious (sound tooth surface) lesion group that comprised the 0 scores for each method and the visual change in enamel group that included both score 1 and score 2 groups for each method." Therefore more severe levels of caries were not included in the results
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Low 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? 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?   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)
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)?      
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 (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? No    
Could the patient flow have introduced bias?   High risk  

EDJ = enamel‐dentine junction; FOTI = fibre optic transillumination; ICDAS = International Caries Detection and Assessment System; LF = laser fluorescence; OCT = optical coherence tomography; ROC = receiver operating characteristic; QLF = quantitative light‐induced fluorescence.