Muller‐Bolla 2017.
Study characteristics | |||
Patient Sampling | Method of sampling: unclear how participants were identified Included conditions: enamel lesions, possibly cavitated, "Caries‐free subjects (without carious lesions diagnosed by both visual examination and bitewing radiographs) or uncooperative children during the examination were excluded" Teeth: primary and permanent, premolars and molars Sealants: unclear Surface: occlusal |
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Patient characteristics and setting | Age: 5 to 15 years Sex: 60% male Ethnicity: not reported Country: France Setting: university hospital, attending paediatric clinic Number of participants/teeth/sites: 103 participants/743 sites Prevalence: enamel 0.72, dentine 0.29 |
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Index tests | Category of test: DIAGNOdent pen and Soprolife Sequence of test(s): visual and radiograph (reference standard) followed by Soprolife and DIAGNOdent pen Examiner training and calibration: 1 day calibration session Teeth cleaning prior to examination: sodium bicarbonate powder‐cleaning tool was used for 5 to 10 seconds per tooth Tooth drying prior to examination: not reported Threshold applied: Soprolife: sound ‐ shiny green, outer enamel ‐ tiny, thin red or grey shimmer in the pits and fissure, inner enamel ‐ red shimmer, grey or black colouration in the pits and fissure, dentine ‐ red areas wider than fissures; surface roughness occurs, possibly grey or rough grey zone visible DIAGNOdent pen: 0‐12 sound, 13‐24 enamel, 25+ dentine Device specifics: fibre tip for DIAGNOdent pen, Soprolife ‐ "studied using the SoproImaging software" |
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Target condition and reference standard(s) | Category: visual (ICDAS) and radiograph Sequence of index test and reference standard: reference standard before Soprolife and DIAGNOdent pen Training of examiner: experienced examiners with 1 day training Blinding to index test: yes Multiple tests: yes Site selection: full surface assessed Target condition: ICDAS 1 to 6 |
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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 | Prevalence of caries for primary and permanent dentition unknown so have to use the mixed dentition results | ||
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? | No | ||
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? | High 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? | 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? | High 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? | Yes | ||
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? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |