Krause 2007.
Study characteristics | |||
Patient Sampling | Method of sampling: selected "non‐cavitated occlusal carious lesions requiring operative intervention (score 3) or teeth where no or preventive treatment was indicated by visual examination and/or bitewing radiographs (scores 0, 1, or 2) were selected" Included conditions: no cavitation or early lesions Teeth: permanent premolars and molars Sealants: no Surface: occlusal |
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Patient characteristics and setting | Age: mean 36 (+‐ 8 years) Sex: 34 male, 48 female Ethnicity: not reported Country: Germany Setting: unclear Number of participants/teeth/sites: 82 participants/94 teeth Prevalence: enamel not reported, dentine 0.51 |
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Index tests | Category of test: DIAGNOdent and DIAGNOdent pen Sequence of test(s): visual and radiograph (these determined whether excavation was necessary) then DIAGNOdent/pen Examiner training and calibration: not reported Teeth cleaning prior to examination: "professional cleaning of the occlusal surfaces using a rotating soft rubber cup and plain water spray" Tooth drying prior to examination: briefly drying the teeth with air pressure Threshold applied: calculated in study for dentine level only Device specifics: tip specifics not reported |
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Target condition and reference standard(s) | Category: excavation of those lesions identified through visual and radiograph tests Sequence of index test and reference standard: reference standard then index tests Training of examiner: not reported Blinding to index test: not reported Multiple tests: no Site selection: occlusal surface Target condition: sound, enamel, dentine |
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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 |
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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? | Low concern | ||
DOMAIN 2: Index Test (All) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | No | ||
If a threshold was used, was it pre‐specified? | No | ||
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? | 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) | |||
DOMAIN 2: Index Test (Blue fluorescence) | |||
DOMAIN 2: Index Test (Red fluorescence) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | No | ||
If a threshold was used, was it pre‐specified? | No | ||
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? | High 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? | No | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | High risk |