Kockanat 2017.
Study characteristics | |||
Patient Sampling | Method of sampling: unclear Included conditions: non‐cavitated; "occlusal surfaces of the teeth had minimal macroscopic destruction" Teeth: primary molars Sealants: unclear Surface: occlusal |
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Patient characteristics and setting | Age: 9 to 12 years Sex: not reported Ethnicity: not reported Country: Turkey Setting: in vivo study conducted in dental hospital, followed by in vitro after extraction Number of participants/teeth/sites: 120 teeth (144 teeth were examined and measurements made with caries detection devices, but 120 of the 144 teeth were reported; due to inconsistencies in caries measurement results), clarification provided by study author Prevalence: enamel 0.78, dentine 0.32 |
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Index tests | Category of test: DIAGNOdent pen and Sopro camera Sequence of test(s): visual, SoproLife, DIAGNOdent pen then CarieScan PRO Examiner training and calibration: unclear, 2 independent examiners Teeth cleaning prior to examination: plaque removed, washed without pumice Tooth drying prior to examination: air water spray, dried again for 5 seconds prior to DD Threshold applied: DIAGNOdent pen: 0‐13 sound, 14‐29 enamel, 30+ dentine Sopro camera: (0) no visible radiolucency; (1) radiolucency in the enamel; (2) radiolucency in the dentine, involving the surface or the outer third of the dentine, and (3) radiolucency in the dentine, involving the inner third of the dentine Device specifics: cylinder sapphire tip for DIAGNOdent pen, "The images were recorded to Sopro Imaging program and evaluated according to the criteria of Rechmann" |
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Target condition and reference standard(s) | Category: histology Sequence of index test and reference standard: index tests then reference standard Training of examiner: not reported Blinding to index test: not reported Multiple tests: no Site selection: sectioned teeth Target condition: sound, outer half of enamel, inner half of enamel, outer half of dentine, deep dentine |
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Flow and timing | Participants with index test but no reference standard: 24 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 | Data used for examiner 1, with the comparison of in vivo index test versus histology Study authors contacted for clarification of study data | ||
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? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
If multiple tests were applied were different examiners used for each (in vivo)? | Yes | ||
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? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
If multiple tests were applied were different examiners used for each (in vivo)? | Yes | ||
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? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Low 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? | No | ||
Could the patient flow have introduced bias? | High risk |