Huth 2008.
Study characteristics | |||
Patient Sampling | Method of sampling: randomised Included conditions: no cavitation and early lesions Teeth: permanent molars Sealants: no Surface: occlusal |
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Patient characteristics and setting | Age: not reported Sex: not reported Ethnicity: not reported Country: Switzerland Setting: dental hospital Number of participants/teeth/sites: 120 participants Prevalence: not reported |
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Index tests | Category of test: DIAGNOdent pen Sequence of test(s): index tests (visual, radiograph, DIAGNOdent pen) performed prior to reference standard Examiner training and calibration: unclear, completed by a dental professional Teeth cleaning prior to examination: yes Tooth drying prior to examination: yes Threshold applied: calculated in study, multiple thresholds investigated within study Device specifics: not reported |
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Target condition and reference standard(s) | Category: excavation or visual/radiograph with follow‐up Sequence of index test and reference standard: index test then reference standard Training of examiner: experienced Blinding to index test: unclear Multiple tests: yes Site selection: unclear which site was investigated with which test Target condition: sound, enamel, dentinal lesions |
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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 | Data not useable as reported the mean for DIAGNOdent readings | ||
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? | Yes | ||
Could the selection of patients have introduced bias? | Low 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) | |||
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? | 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 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? | Yes | ||
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 |