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

Li 2006.

Study characteristics
Patient Sampling Method of sampling: unclear
Included conditions: non‐cavitated
Teeth: primary molars
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: 5 to 6 years, mean 5.3
Sex: not reported
Ethnicity: not reported
Country: China
Setting: school based (kindergarten)
Number of participants/teeth/sites: 72 participants/541 teeth
Prevalence: not reported
Index tests Category of test: DIAGNOdent
Sequence of test(s): DIAGNOdent then visual
Examiner training and calibration: not reported
Teeth cleaning prior to examination: yes, with a portable low‐speed hand‐piece brush
Tooth drying prior to examination: yes, dried with high pressure air (triple syringe)
Threshold applied: < 10 intact, 10‐14 early enamel caries, 15‐20 enamel caries, 21‐30 early dentine caries, > = 31 deep dentine caries
Device specifics: tip A
Target condition and reference standard(s) Category: visual
Sequence of index test and reference standard: following but influenced by DIAGNOdent
Training of examiner: not reported
Blinding to index test: no "visual examination was performed on occlusal spots that had the highest laser fluorescence scores during DIAGNOdent examination"
Multiple tests: no
Site selection: sectioned teeth
Target condition: Caries (Ekstrand’s index)
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 Paper translated by Cochrane author, data not useable as 2x2 table not attainable, study investigates median DIAGNOdent values at each Ekstrand code
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? Unclear    
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)?      
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)?      
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? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? No    
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