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. 2021 Jan 27;2021(1):CD013855. doi: 10.1002/14651858.CD013855

Sidi 1988.

Study characteristics
Patient Sampling Method of sampling: selected ‐ participants taking part in a caries trial
Included conditions: only surfaces considered to be sound by clinical evaluation were evaluated with the transillumination device
Teeth: permanent molar and premolars
Sealants: not reported
Restorations: not reported
Surface: approximal
Patient characteristics and setting Age: 21 to 64 years (mean 28 years)
Sex: not reported
Ethnicity: not reported
Country: not reported
Setting: clinical trial; "carried out away from the dental surgery"
Number of participants/teeth/sites: 456 participants, 4405 surfaces (71 participants could not be radiographed within the study)
Prevalence: enamel 0.03, dentine 0.01 (very low prevalence results in high concern for applicability)
Index tests Category of test: FOTI
Sequence of test(s): visual examination preceded radiographs and transillumination, radiographs developed and interpreted at a later date
Examiner training and calibration: not reported
Threshold applied: sound, enamel, dentine
Device specifics: liquid light transmission cord: Kulzer and Co, placed buccally and lingually
Target condition and reference standard(s) Category: radiographs
Sequence of index test and reference standard: reference standard completed prior to transillumination
Training of examiner: not reported
Blinding to index test: yes ‐ attempt made to blind examiners to index test results
Multiple tests: visual completed but without separation so not a viable reference standard
Site selection: all surfaces
Target condition: sound, enamel, or dentine
Flow and timing Participants with index test but no reference standard: all participants that received radiographs also were examined with transillumination ‐ 71 participants did not receive radiographs, unclear on the number that received a clinical examination but did not receive transillumination test
Participants with reference standard but no index test: 0
Time interval between tests: unclear
Participants receiving both tests but excluded from results: 0
Comparative  
Notes Buccal and lingual results totaled for our data analysis, from table IV
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? Unclear    
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 tests)
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)? Unclear    
Could the conduct or interpretation of the index test have introduced bias?   Unclear 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?     High
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