Ozsevik 2015.
Study characteristics | |||
Patient Sampling | Method of sampling: selected Included conditions: non‐cavitated and enamel lesions Teeth: permanent molars ‐ "the teeth had no cavitations, approximal restorations, or hypoplastic pits, as judged by the naked eye" Sealants: unclear Surface: approximal |
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Patient characteristics and setting | Age: not reported Sex: not reported Ethnicity: not reported Country: Turkey Setting: extracted teeth, "the teeth were placed in arch models and fixed with melted utility wax. The best contact points possible were achieved" Number of participants/teeth/sites: 87 teeth/156 sites Prevalence: enamel 0.63, dentine 0.35 |
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Index tests | Category of test: DIAGNOdent pen and Midwest, "The teeth were placed in arch models and fixed with melted utility wax. The best contact points possible were achieved" Sequence of test(s): index tests (DIAGNOdent pen and Midwest) followed by reference standard Examiner training and calibration: 1 trained examiner Teeth cleaning prior to examination: toothbrush and water (15 seconds), then 1 prophyflex Tooth drying prior to examination: air dried 3 seconds Threshold applied: sound 0–9; enamel 9.1–15; dentine > 15 Device specifics: DIAGNOdent pen: tip 1; Midwest: "red LED radiation was transported to the occlusal or approximal area using the tip of the probe in contact with the occlusal surfaces" |
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Target condition and reference standard(s) | Category: histology Sequence of index test and reference standard: index test then reference standard Training of examiner: calibrated Blinding to index test: yes Multiple tests: no Site selection: sectioned teeth Target condition: sound, enamel, 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: 1 week to allow for separation of teeth Participants receiving both tests but excluded from results: 0 |
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Comparative | |||
Notes | No evidence that the results of either index test would influence the other | ||
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? | 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? | Yes | ||
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? | Yes | ||
Could the patient flow have introduced bias? | Low risk |