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

Simon 2016.

Study characteristics
Patient Sampling Method of sampling: systematically sampled from attending population, no clear reporting of inclusion criteria regarding the caries status in sampled teeth
Included conditions: participants scheduled for orthodontic extractions
Teeth: permanent premolars
Sealants: not reported
Restorations: not reported
Surface: occlusal and approximal
Patient characteristics and setting Age: 12 to 60 years
Sex: not reported
Ethnicity: not reported
Country: USA
Setting: clinical setting, dental school, followed by extraction
Number of participants/teeth/sites: 40 participants teeth, 109 occlusal and approximal sites
Prevalence:
occlusal ‐ enamel 0.82, dentine not reported
approximal ‐ enamel 0.28, dentine not reported
Index tests Category of test: NIR transillumination
Sequence of test(s): index tests in the clinical setting in the following order: (i) conventional photos; (ii) cross‐polarized NIR; (iii) occlusal NIR; (iv) approximal NIR. Digital radiographs followed in the in vitro setting
Examiner training and calibration: 1 examiner assessed the NIR and another the radiographs, each was an experienced dentist with over 20 years experience
Threshold applied: S ‐ sound; E1 ‐ outer half of enamel; E2 ‐ inner half of enamel; D1 ‐ inner half of dentine; D2 ‐ second half of dentine
Device specifics: "Light centered at 1310 nm is generated using a superluminescent laser diode (SLD), Model SLD72 (COVEGA Corporation, Jessup, MD) with 50 nm bandwidth. Fiber optic cables are used to deliver the light into a Teflon diffusing element"
Note ‐ high applicability as device is not commercially available; "near‐IR transillumination and near‐IR reflectance probes that we fabricated in our laboratory for both occlusal and approximal lesions"
Target condition and reference standard(s) Category: histology ‐ polarized light microscopy (PLM) was used for histological examination
Sequence of index test and reference standard: index test then reference standard
Training of examiner: not reported
Blinding to index test: unclear
Multiple tests: no
Site selection: sectioned teeth
Target condition: sound, inner/outer enamel, inner/outer 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? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
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 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?   Low 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?   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? Yes    
Could the patient flow have introduced bias?   Low risk