Jablonski‐Momeni 2014.
Study characteristics | |||
Patient Sampling | Method of sampling: selected Included conditions: not clearly stated in the recruitment section, results report acceptable level of dentinal lesions Teeth: permanent molars and premolars Sealants: not reported Surface: occlusal |
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Patient characteristics and setting | Age: minimum age of 18 years, mean 27.4 Sex: 10 male, 16 female Ethnicity: not reported Country: Germany Setting: assumed to be a clinical setting as the aim was to determine which surfaces should be restored Number of participants/teeth/sites: 26 teeth/306 sites Prevalence: enamel 0.17, dentine 0.12 |
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Index tests | Category of test: VistaProof Sequence of test(s): unclear on the sequence of tests, reported as visual first then VistaProof followed by radiograph and excavation where propriae Examiner training and calibration: 2 trained examiners Teeth cleaning prior to examination: yes, cleaned and air‐dried using a triplex syringe Tooth drying prior to examination: as above Threshold applied: 0–0.9 sound; 1.0–1.4 early stage of enamel lesion; 1.5–1.9 deep enamel lesion; 2.0–2.4 dentine caries; and > 2.4 deep dentine caries Device specifics: specific software used for analysis, "Sound enamel and carious lesions are visualised in colour and numerically (on a scale from 0 to 4)" |
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Target condition and reference standard(s) | Category: visual (ICDAS) for all surfaces, where appropriate radiographs and excavation where applied Sequence of index test and reference standard: it seems the index test was performed after visual examination and before radiographs, so index may have influenced decision Training of examiner: 1 experienced examiner Blinding to index test: no Multiple tests: yes 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: 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? | 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? | 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) | |||
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? | Low 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? | No | ||
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? | Yes | ||
Could the patient flow have introduced bias? | High risk |