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

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
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
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"
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
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
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