Skip to main content
. 2020 Dec 8;2020(12):CD013811. doi: 10.1002/14651858.CD013811

Kockanat 2017.

Study characteristics
Patient Sampling Method of sampling: unclear
Included conditions: non‐cavitated; "occlusal surfaces of the teeth had minimal macroscopic destruction"
Teeth: primary molars
Sealants: unclear
Surface: occlusal
Patient characteristics and setting Age: 9 to 12 years
Sex: not reported
Ethnicity: not reported
Country: Turkey
Setting: in vivo study conducted in dental hospital, followed by in vitro after extraction
Number of participants/teeth/sites: 120 teeth (144 teeth were examined and measurements made with caries detection devices, but 120 of the 144 teeth were reported; due to inconsistencies in caries measurement results), clarification provided by study author
Prevalence: enamel 0.78, dentine 0.32
Index tests Category of test: DIAGNOdent pen and Sopro camera
Sequence of test(s): visual, SoproLife, DIAGNOdent pen then CarieScan PRO
Examiner training and calibration: unclear, 2 independent examiners
Teeth cleaning prior to examination: plaque removed, washed without pumice
Tooth drying prior to examination: air water spray, dried again for 5 seconds prior to DD
Threshold applied:
DIAGNOdent pen: 0‐13 sound, 14‐29 enamel, 30+ dentine
Sopro camera: (0) no visible radiolucency; (1) radiolucency in the enamel; (2) radiolucency in the dentine, involving the surface or the outer third of the dentine, and (3) radiolucency in the dentine, involving the inner third of the dentine
Device specifics: cylinder sapphire tip for DIAGNOdent pen, "The images were recorded to Sopro Imaging program and evaluated according to the criteria of Rechmann"
Target condition and reference standard(s) Category: histology
Sequence of index test and reference standard: index tests then reference standard
Training of examiner: not reported
Blinding to index test: not reported
Multiple tests: no
Site selection: sectioned teeth
Target condition: sound, outer half of enamel, inner half of enamel, outer half of dentine, deep dentine
Flow and timing Participants with index test but no reference standard: 24
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 Data used for examiner 1, with the comparison of in vivo index test versus histology
Study authors contacted for clarification of study data
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? Yes    
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? 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)
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 (Red fluorescence)
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?   Low 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