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

Lederer 2018.

Study characteristics
Patient Sampling Method of sampling: selected
Included conditions: sound or early enamel lesions; "either an intact, sound interproximal surface or non‐cavitated proximal caries lesions"
Teeth: permanent
Sealants: not reported
Restorations: excluded
Surface: approximal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Germany
Setting: extracted teeth
Number of participants/teeth/sites: 53 teeth, 106 teeth
Prevalence: enamel 0.36, dentine 0.16
Index tests Category of test: 2 tests: NIR light ‐ DIAGNOcam, also near‐infrared light combined with high‐dynamic‐range imaging (NIR‐HDRI)
Sequence of test(s): NIR and NIR‐HDRI, prior to reference standard
Examiner training and calibration: "2 experienced examiners ..... were given a practical and theoretical training session", examiner assessments completed independently and repeated after 2 weeks
Threshold applied: no decay, enamel, enamel with single point of contact to dentino‐enamel junction, enamel with extensive contact to dentino‐enamel junction, dentine
Device specifics:
  • DIAGNOcam ‐ "Instead of the clinical tip of the DC, the laser optical unit of the in vitro model was used for transillumination to obtain comparable images. The DC could be pivoted over the tooth, and images obtained with the KaVo KiD (KaVo integrated Desktop) software"

  • NIR‐HDRI ‐ "Images were obtained with an above‐mounted NIR camera manufactured by IDS (UI‐1241LE‐NIR‐GL, Imaging Development Systems GmbH) together with a Tamron 50‐mm lens"


Note ‐ applicability is "high concern" as techniques used in paper are specifically designed scenarios established in an in vitro setting which are not currently available for a clinical setting
Target condition and reference standard(s) Category: microCT
Sequence of index test and reference standard: reference standard followed index test assessments
Training of examiner: unclear; "Measurements were taken 3 times by one examiner, and the mean values calculated"
Blinding to index test: unclear
Multiple tests: no
Site selection: extracted tooth microCT scan
Target condition: radiolucency in the outer, or the inner half of the enamel, and radiolucency in the 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  
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 tests)
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)? No    
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?     High
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?   Unclear 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