Rocha 2003.
Study characteristics | |||
Patient Sampling | Method of sampling: selected, "Fifty occlusal sites were selected for this study" Included conditions: no cavitation and early lesions Teeth: primary molars Sealants: excluded Surface: occlusal |
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Patient characteristics and setting | Age: 10 to 11 years Sex: not reported Ethnicity: not reported Country: Brazil Setting: children with teeth close to exfoliation Number of participants/teeth/sites: 29 participants/50 sites Prevalence: enamel 0.58, dentine 0.14 |
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Index tests | Category of test: DIAGNOdent Sequence of test(s): DIAGNOdent, visual, radiograph followed by reference standard Examiner training and calibration: previously trained Teeth cleaning prior to examination: "professionally cleaned" Tooth drying prior to examination: 5 seconds with dried air Threshold applied: "The cutoff limits for all and dentin lesions were values of 6 and 21" Device specifics: tip A, marked on photograph, then maximum value, mean of 3 measurements |
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Target condition and reference standard(s) | Category: histology Sequence of index test and reference standard: index test conducted before reference standard Training of examiner: not reported Blinding to index test: yes Multiple tests: no Site selection: sectioned tooth Target condition: sound, outer enamel, inner enamel and first third dentine middle and inner 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? | 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? | 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? | Yes | ||
Could the patient flow have introduced bias? | Low risk |