Lee 2018.
Study characteristics | |||
Patient Sampling | Method of sampling: "selected from a pool of extracted human teeth having questionable caries" Included conditions: questionable caries Teeth: permanent premolars and molars Sealants: not reported Surface: occlusal |
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Patient characteristics and setting | Age: 20 years or older Sex: not reported Ethnicity: not reported Country: South Korea Setting: extracted teeth Number of participants/teeth/sites: 66 teeth (4 were broken during sectioning) Prevalence: 0.81 enamel, 0.11 dentine |
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Index tests | Category of test: QLF–Digital Biluminator™ 2+, decrease in fluorescence (ΔF) and the increase in red fluorescence (ΔR) are both reported Sequence of test(s): index test (QLF) followed by reference standard Examiner training and calibration: not reported Teeth cleaning prior to examination: calculus and soft tissue removed with scaler Tooth drying prior to examination: not reported Threshold applied: optimum thresholds calculated in study: ΔF sound 62, enamel 82, dentine 93 Device specifics: "an analysis patch was delimited by drawing a border that pointed at sound parts without discolorations from the stained pits and fissures with suspected caries according to manufacturer recommendations using the QLF‐D software" |
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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: "no enamel demineralization or a narrow surface zone of opacity (scored as 0), enamel demineralization limited to the outer 50% of the enamel layer (scored as 1), demineralization involving the inner 50% of enamel up to the DEJ (scored as 2), and demineralization involving the outer 50% of the dentine (scored as 3)" |
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Flow and timing | Participants with index test but no reference standard: 4 ‐ reported that these were broken during sectioning Participants with reference standard but no index test: 0 Time interval between tests: minimal Participants receiving both tests but excluded from results: 0 |
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Comparative | |||
Notes | Data reported for the decrease in fluorescence (ΔF) | ||
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? | 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? | No | ||
If multiple tests were applied were different examiners used for each (in vivo)? | Unclear | ||
Could the conduct or interpretation of the index test have introduced bias? | High 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) | |||
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? | No | ||
If multiple tests were applied were different examiners used for each (in vivo)? | Unclear | ||
Could the conduct or interpretation of the index test have introduced bias? | High risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (Blue fluorescence) | |||
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? | Yes | ||
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? | Low risk |