Jablonski‐Momeni 2016.
Study characteristics | |||
Patient Sampling | Method of sampling: unclear Included conditions: non‐cavitated and early lesions (ICDAS 0‐2) Teeth: primary (this entry is for primary) and permanent Sealants: not reported Surface: occlusal |
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Patient characteristics and setting | Age: 5 to 12 years, mean age 9.1 Sex: 17 male, 18 female Ethnicity: not reported Country: Germany Setting: "recruited in a dental office" Number of participants/teeth/sites: 35 participants/205 primary, 214 permanent teeth Prevalence: primary: enamel 0.18, dentine 0 permanent: enamel 0.35, dentine 0 |
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Index tests | Category of test: VistaProof Sequence of test(s): visual prior to VistaProof, so reference standard then index test Examiner training and calibration: not reported Teeth cleaning prior to examination: yes, rotating brush and paste, then rinsed with a 3 in 1 syringe Tooth drying prior to examination: unclear Threshold applied: 0–1.2 sound; 1.3–1.5 enamel caries; > 1.5 dentine caries Device specifics: "Each image was analyzed by the specific software (DBSWIN, Durr Dental)" |
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Target condition and reference standard(s) | Category: visual (ICDAS) for all surfaces Sequence of index test and reference standard: the index test was performed after visual examination Training of examiner: unclear Blinding to index test: not reported Multiple tests: no Site selection: all selected occlusal surfaces Target condition: ICDAS categories: 0 = sound; 1 = first visible sign of non‐cavitated lesion seen only when the tooth is dry; 2 = visible non‐cavitated lesion seen when wet and dry; 3 = microcavitation in enamel; code 4 = non‐cavitated lesion extending into dentine seen as an undermining shadow; code 5 = small cavitated lesion with visible dentine: less than 50% of surface; and code 6 = large cavitated lesion with visible 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: 13, "Thirteen teeth were unable to be monitored for 1 year (due to restorative treatment or extraction)" |
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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? | 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? | Low concern | ||
DOMAIN 2: Index Test (All) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Unclear | ||
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? | Unclear 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? | Unclear | ||
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? | Unclear 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? | High | ||
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? | No | ||
Could the patient flow have introduced bias? | Low risk |