Bozdemir 2013.
Study characteristics | |||
Patient Sampling | Method of sampling: unclear Included conditions: no cavitation and early lesions Teeth: permanent molars Sealants: no Surface: occlusal |
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Patient characteristics and setting | Age: 20 to 25 years, mean 20.2 Sex: 7 male, 30 female Ethnicity: not reported Country: Turkey Setting: dental school Number of participants/teeth/sites: 37 teeth/156 surfaces Prevalence: not reported, only those suspected of caries received reference standard so data do not reflect full sample |
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Index tests | Category of test: DIAGNOdent pen and Midwest Sequence of test(s): index tests performed prior to reference standard, same 2 examiners completed all tests Examiner training and calibration: "previously trained" Teeth cleaning prior to examination: rubber cup and paste Tooth drying prior to examination: air dried for 3 seconds Threshold applied: DIAGNOdent pen: 0–13 healthy, 14–20 enamel, 21–29 superficial dentine, > 30 deep dentine Midwest: no signal/green light ‐ healthy, slow signal/red light ‐ enamel, medium signal/red light ‐ superficial dentine, rapid or continuous signal/red light ‐ deep dentine Device specifics: DIAGNOdent pen ‐ cone shaped tip |
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Target condition and reference standard(s) | Category: excavation ‐ only those diagnosed as having caries by index tests were investigated Sequence of index test and reference standard: index test then reference standard Training of examiner: not reported Blinding to index test: yes Multiple tests: no Site selection: complete occlusal fissure Target condition: sound, enamel (outer), enamel (inner), dentine (outer), dentine (inner) |
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Flow and timing | Participants with index test but no reference standard: 30 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 used because 156 sites were included but only 126 were opened | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
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? | High | ||
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? | 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? | 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? | 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? | 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? | No | ||
Could the patient flow have introduced bias? | High risk |