Pinelli 2002.
Study characteristics | |||
Patient Sampling | Method of sampling: selected Included conditions: no cavitation and early lesions, "none of the teeth showed macroscopic signs of cavity formation with exposure into dentin" Teeth: permanent molars, "the inclusion criterion was the presence of at least one white‐spot caries lesion on a free smooth surface" Sealants: not reported Surface: "free smooth surfaces" |
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Patient characteristics and setting | Age: 11 to 17 years Sex: not reported Ethnicity: not reported Country: Brazil Setting: school, "The examinations were carried out in classrooms under good light conditions" Number of participants/teeth/sites: 50 participants/220 surfaces Prevalence: enamel 0.50 |
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Index tests | Category of test: DIAGNOdent Sequence of test(s): visual then DIAGNOdent Examiner training and calibration: yes Teeth cleaning prior to examination: floss and brush Tooth drying prior to examination: air dried, 10 seconds Threshold applied: 0‐4 arrested, 5+ active Device specifics: "DIAGNOdent was used to examine only the lesions detected by visual inspection" |
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Target condition and reference standard(s) | Category: visual Sequence of index test and reference standard: reference standard performed before index test Training of examiner: calibration completed Blinding to index test: yes Multiple tests: no Site selection: those identified visually Target condition: active or inactive 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: 1 week to allow for separation of teeth Participants receiving both tests but excluded from results: 0 |
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Comparative | |||
Notes | Inclusion criteria suggests sound teeth were excluded, but the results confirm that sound teeth were present in the sample | ||
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? | Yes | ||
If multiple tests were applied were different examiners used for each (in vivo)? | |||
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? | No | ||
If a threshold was used, was it pre‐specified? | Yes | ||
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? | 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? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |