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

Sinanoglu 2014.

Study characteristics
Patient Sampling Method of sampling: unclear ‐ referred patients, "Teeth exhibiting proximal caries in the radiological examination were excluded"
Included conditions: non‐cavitated and early lesions, "Exclusion criteria for the teeth were the presence of proximal caries, surfaces that made it impossible to simulate the contact point, large carious lesions, enamel anomalies, any intrinsic or extrinsic staining, and any restorations or fissure sealants"
Teeth: permanent molar and/or premolar tooth
Sealants: no
Surface: occlusal
Patient characteristics and setting Age: not reported
Sex: not reported
Ethnicity: not reported
Country: Turkey
Setting: university dental school
Number of participants/teeth/sites: 35 participants/217 teeth at first examination; 1 week later 11 participants/82 surfaces
Prevalence: not clearly reported
Index tests Category of test: DIAGNOdent pen
Sequence of test(s): visual, radiograph, DIAGNOdent, then reference standard
Examiner training and calibration: 2 experienced examiners and calibrated
Teeth cleaning prior to examination: yes, "teeth were professionally cleaned using rotating brushes without any prophylactic pastes"
Tooth drying prior to examination: "first examined wet and then air‐dried for 5 sec"
Threshold applied: 0‐12 sound, 13‐24 beginning demineralization, > 25 strong demineralization
Device specifics: probe tip 2
Target condition and reference standard(s) Category: excavation of severe caries, the remainder were based on a combination of visual and radiograph examinations
Sequence of index test and reference standard: index test partly informs reference standard, unclear exactly how this was done
Training of examiner: not reported
Blinding to index test: not possible
Multiple tests: yes, visual and radiograph; plus excavation
Site selection: occlusal surface under investigation
Target condition: no caries, enamel, or dentine
Flow and timing Participants with index test but no reference standard: unclear how reference standard for first series of examinations in conducted, suspected that many may be missing a reference standard
Participants with reference standard but no index test: 0
Time interval between tests: up to 1 week
Participants receiving both tests but excluded from results: 0
Comparative  
Notes Unclear how Table 6 results of sensitivity and specificity are calculated, whether these are only reporting the participants that underwent excavation or a hybrid reference standard was applied to assess all participants. Also Table 9 not clear with thresholds applied and whether any sound teeth were included
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?     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?   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? 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?   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? Unclear    
Were all patients included in the analysis? Unclear    
Could the patient flow have introduced bias?   Unclear risk