Shwetha 2017.
Study characteristics | |||
Patient Sampling | Method of sampling: unclear Included conditions: not clearly reported, "primary molars with questionable fissures that were extracted for therapeutic and orthodontic reasons" Teeth: primary molars Sealants: no Surface: occlusal |
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Patient characteristics and setting | Age: not reported Sex: not reported Ethnicity: not reported Country: India Setting: extracted teeth Number of participants/teeth/sites: 40 teeth/89 sites Prevalence: enamel 1.00, dentine 0.55 |
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Index tests | Category of test: DIAGNOdent Sequence of test(s): visual, radiograph, DIAGNOdent, then reference standard Examiner training and calibration: not reported Teeth cleaning prior to examination: yes, "cleaned of all pulp remnants" Tooth drying prior to examination: not reported Threshold applied: 0‐12 sound, 13‐24 beginning demineralization, > 25 strong demineralization Device specifics: no tip specifics described, mean of 3 records reported |
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Target condition and reference standard(s) | Category: histology Sequence of index test and reference standard: index test before reference standard Training of examiner: not reported Blinding to index test: not reported Multiple tests: no Site selection: sectioned teeth Target condition: enamel, or 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 | Unable to extract data for 2x2 table as the sensitivity and specificity reported do not agree to the prevalence of disease in the text. The text states there were no sound sites (89 total sites, 43 enamel caries, 46 dentine) | ||
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? | High | ||
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)? | 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? | Yes | ||
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? | 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? | Unclear 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? | Yes | ||
Could the patient flow have introduced bias? | Low risk |