Sinanoglu 2014.
Study characteristics | |||
Patient Sampling | Method of sampling: unclear ‐ referred patients, "Teeth exhibiting proximal caries in the radiological examination were excluded" Included conditions: non‐cavitated and early lesions, "Exclusion criteria for the teeth were the presence of proximal caries, surfaces that made it impossible to simulate the contact point, large carious lesions, enamel anomalies, any intrinsic or extrinsic staining, and any restorations or fissure sealants" Teeth: permanent molar and/or premolar tooth Sealants: no Surface: occlusal |
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Patient characteristics and setting | Age: not reported Sex: not reported Ethnicity: not reported Country: Turkey Setting: university dental school Number of participants/teeth/sites: 35 participants/217 teeth at first examination; 1 week later 11 participants/82 surfaces Prevalence: not clearly reported |
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Index tests | Category of test: DIAGNOdent pen Sequence of test(s): visual, radiograph, DIAGNOdent, then reference standard Examiner training and calibration: 2 experienced examiners and calibrated Teeth cleaning prior to examination: yes, "teeth were professionally cleaned using rotating brushes without any prophylactic pastes" Tooth drying prior to examination: "first examined wet and then air‐dried for 5 sec" Threshold applied: 0‐12 sound, 13‐24 beginning demineralization, > 25 strong demineralization Device specifics: probe tip 2 |
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Target condition and reference standard(s) | Category: excavation of severe caries, the remainder were based on a combination of visual and radiograph examinations Sequence of index test and reference standard: index test partly informs reference standard, unclear exactly how this was done Training of examiner: not reported Blinding to index test: not possible Multiple tests: yes, visual and radiograph; plus excavation Site selection: occlusal surface under investigation Target condition: no caries, enamel, or dentine |
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Flow and timing | Participants with index test but no reference standard: unclear how reference standard for first series of examinations in conducted, suspected that many may be missing a reference standard Participants with reference standard but no index test: 0 Time interval between tests: up to 1 week Participants receiving both tests but excluded from results: 0 |
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Comparative | |||
Notes | Unclear how Table 6 results of sensitivity and specificity are calculated, whether these are only reporting the participants that underwent excavation or a hybrid reference standard was applied to assess all participants. Also Table 9 not clear with thresholds applied and whether any sound teeth were included | ||
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? | No | ||
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? | No | ||
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? | 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? | Unclear | ||
Were all patients included in the analysis? | Unclear | ||
Could the patient flow have introduced bias? | Unclear risk |