Strober 2013.
Methods | Trial design: parallel‐group Location: private dental offices, USA Funding source: NIDCR |
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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 |
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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 |