Matos 2011.
Study characteristics | |||
Patient Sampling | Method of sampling: randomly selected from available patients Included conditions: "children seeking dental treatment at the School of Dentistry of the University of São Paulo were selected" Teeth: primary, molars Sealants: not reported Surface: occlusal |
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Patient characteristics and setting | Age: 4 to 12 years Sex: 30 male, 38 female Ethnicity: not reported Country: Brazil Setting: dental hospital patients Number of participants/teeth/sites: 383 teeth in 68 participants Prevalence: enamel 0.91, dentine 0.05 |
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Index tests | Category of test: DIAGNOdent pen and VistaProof Sequence of test(s): visual inspection and radiographic methods, then LF pen, fluorescence camera Examiner training and calibration: yes Teeth cleaning prior to examination: rotating bristle brush and a pumice/water slurry Tooth drying prior to examination: standardized drying time of 5 seconds Threshold applied: DIAGNOdent pen: sound 0–4; enamel lesions > 4; dentine lesion > 34 VistaProof: sound 0–1.1; enamel lesions > 1.1; dentine lesions > 1.4 Device specifics: DIAGNOdent pen: probe tip 2 VitsaProof: "the image of each surface was recorded by the camera software (DBSWIN, Dürr Dental)" |
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Target condition and reference standard(s) | Category: visual for enamel threshold, excavation and visual used for dentine threshold Sequence of index test and reference standard: following index test, but performed by same examiner during the same appointment Training of examiner: yes Blinding to index test: unclear ‐ the same examiner performed all tests so difficult to blind results Multiple tests: yes Site selection: a drawing of the occlusal surface was made to indicate the selected site Target condition: sound, enamel, dentine |
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Flow and timing | Participants with index test but no reference standard: 25 for enamel caries as examiners did not agree 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? | 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? | 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) | |||
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 (Red fluorescence) | |||
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 |