Skip to main content
. 2019 Mar 5;2019(3):CD010526. doi: 10.1002/14651858.CD010526.pub3

Strober 2013.

Methods Trial design: parallel‐group
Location: private dental offices, USA
Funding source: NIDCR
Participants Inclusion criteria: moderate to deep primary occlusal caries (at least 2 mm deep after caries removal) in a first or second permanent molar without caries on other surfaces; at least 1 opposing tooth; periodontal tissues healthy or mildly inflamed without gingival recession/alveolar bone loss; no previous signs and symptoms of pulpal and periapical disease, preoperative sensitivity relieved immediately after removal of stimulus, and no spontaneous pain; at least 1 antagonist tooth with occlusal contact more than 50% of the occlusal surface
Age: 15 to 60 years
Exclusion criteria: either the cavity depth after caries removal was less than 2 mm or a pulp exposure or near pulp exposure, in which a calcium hydroxide agent was placed; psychological disorders; neurological diseases; TMD; pregnancy or lactation; patients taking any analgesic or anti‐inflammatory drugs regularly; allergies to materials used in the trial; teeth with previous restoration(s), tooth surface loss (attrition, erosion, abrasion or abfraction); teeth diagnosed with cracked tooth syndrome; teeth that had received orthodontic treatment in past 3 months
Number of randomised individuals: 341
Number of randomised teeth: 347
Number of individuals evaluated: 333
Dropouts: 8
Interventions RMGI liner under RBC restoration compared to no liner under RBC restoration
Outcomes Postoperative hypersensitivity as measured by CRM on a VAS
Notes Caries classification and dentin caries activity for each lesion, sleep bruxism and caries risk for each patient were also assessed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "On enrolment, eligible participants were randomly assigned one to one (blocking within practice, using random block sizes) between the following treatment arms..."
Allocation concealment (selection bias) Low risk Randomization done centrally ‐ not in each practice
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants may or may not have been blinded – no information provided
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Operator and evaluator were the same person "P‐Is completed restorations according to the treatment arm assigned and liner (if used)" and "P‐Is saw participants for evaluation at one and four weeks after treatment"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All data reported
Selective reporting (reporting bias) Low risk All data reported
Other bias Low risk None detected