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. 2021 Jan 27;2021(1):CD013855. doi: 10.1002/14651858.CD013855

Park 2018.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: unclear
Teeth: permanent incisors (25), premolars (11) and molars (15)
Sealants: not reported
Restorations: not reported
Surface: smooth
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Germany
Setting: extracted teeth
Number of participants/teeth/sites: 51 teeth, 133 sites
Prevalence: enamel 0.73, dentine 0.05
Index tests Category of test: spectral domain OCT
Sequence of test(s): ordering of tests not clear
Examiner training and calibration: examiner was an experienced user of OCT
Threshold applied: ICDAS 0‐4 was applied to OCT
Device specifics: Telesto II (Thorlabs GmbH, Dachau, Germany); "Technical specifications of the SD‐OCT system were as follows: center wavelength 1310 nm ± 107 nm, sensitivity ≤ 106 dB, axial/lateral resolution < 7.5 (air)/15 μm, field of view ≤ 10 mm × 10 mm × 3.5 mm (pixel size 700 × 700 × 512), imaging speed 48–91 kHz, and A‐scan average 1–5"
Target condition and reference standard(s) Category: visual
Sequence of index test and reference standard: unclear ordering of tests
Training of examiner: not reported
Blinding to index test: unclear
Multiple tests: no
Site selection: specified regions of interest
Target condition: ICDAS 0‐4
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 3 studies in this paper that could have been included. The first was in vitro, OCT (swept source) versus histology, could not be included as no data were presented. The second, in vitro part (OCT ‐ spectral domain) is included, above. The third in vivo element (OCT ‐ spectral domain) but samples participants with caries up to ICDAS 4, so we had to exclude this study
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? Unclear    
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 tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
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?   Unclear 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? Unclear    
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