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. 2020 Dec 8;2020(12):CD013811. doi: 10.1002/14651858.CD013811

Huth 2008.

Study characteristics
Patient Sampling Method of sampling: randomised
Included conditions: no cavitation and early lesions
Teeth: permanent molars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Switzerland
Setting: dental hospital
Number of participants/teeth/sites: 120 participants
Prevalence: not reported
Index tests Category of test: DIAGNOdent pen
Sequence of test(s): index tests (visual, radiograph, DIAGNOdent pen) performed prior to reference standard
Examiner training and calibration: unclear, completed by a dental professional
Teeth cleaning prior to examination: yes
Tooth drying prior to examination: yes
Threshold applied: calculated in study, multiple thresholds investigated within study
Device specifics: not reported
Target condition and reference standard(s) Category: excavation or visual/radiograph with follow‐up
Sequence of index test and reference standard: index test then reference standard
Training of examiner: experienced
Blinding to index test: unclear
Multiple tests: yes
Site selection: unclear which site was investigated with which test
Target condition: sound, enamel, dentinal lesions
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
Comparative  
Notes Data not useable as reported the mean for DIAGNOdent readings
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Low 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? No    
If multiple tests were applied were different examiners used for each (in vivo)? Unclear    
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)
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? No    
If multiple tests were applied were different examiners used for each (in vivo)? Unclear    
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 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? No    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   High risk