Burrow 2009.
Methods | Trial design: parallel‐group Location: dental school postgraduate clinic Bangkok, Thailand Funding source: none mentioned |
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Participants | Inclusion criteria: at least 1 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: 18 to 40 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: 72 Number of randomised teeth: 106 Number of individuals evaluated: 70 Dropouts: 2 |
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Interventions | RMGI liner under RBC restoration using 2 different bonding agents compared to no liner under RBC restoration using 2 different bonding agents | |
Outcomes | Postoperative hypersensitivity as measured CRM on a VAS, yes/no criteria, and also by patient reporting | |
Notes | Some participants had multiple restorations in different quadrants | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "... blocking randomization list" |
Allocation concealment (selection bias) | Low risk | Quote: "... sealed envelope" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded but operators were not |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quotes: "One to four restorations were randomly allocated in each patient by a single operator (DB) according to a blocking randomization list." "At recall, the evaluator (DB) was blinded to the restoration that was being evaluated" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Two patients (three restorations) were lost during recall and were excluded before data analysis (from telephone interviewing, these patients reported no postoperative tooth sensitivity in daily function)" |
Selective reporting (reporting bias) | Low risk | Quote: "… five patients (five restorations) missed the one‐week recall; however, these patients were still included in the data analysis. All patients attended the one‐month recall" |
Other bias | Low risk | None detected |