Methods | Trial design: Split‐mouth Location: Dental school, Saudi Arabia Funding source: None mentioned |
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Participants | Inclusion criteria: Occlusal caries on contralateral posterior teeth with small or moderately large carious lesions ‐ the bucco‐lingual dimensions of each cavity were less than half the intercuspal width Age: Males 16‐52 years Exclusion criteria: Orofacial pain, including toothache, percussion tenderness, periapical radiolucency Number of randomised individuals: n/a Number of randomised teeth: 88 Number of individuals evaluated: 44 Dropouts: None |
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Interventions | RMGI liner under RBC restoration (no bonding agent used) compared to no liner (bonding agent only) under RBC restoration | |
Outcomes | Postoperative hypersensitivity as measured by CRM in time (seconds) and patient reporting | |
Notes | Based on these data the study authors concluded that the liner group had less sensitivity but it seems that both groups had no clinically significant sensitivity after 30 days | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "There was randomization in the selection of the right and left teeth for the adhesive or glass‐ionomer lining" Comment: No other additional information was provided ‐ it is unclear how the randomization was performed and how easy it would have been for the operators to deviate from the randomization prescribed |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants may or may not have been blinded – no information provided. Operator was not blinded – knew which tooth received liner |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The measurement of CRM at the recall visits was by another dentist who was unaware of the lining that the experimental teeth had received" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants dropped out |
Selective reporting (reporting bias) | Low risk | All data reported |
Other bias | High risk | A validated instrument to measure patient‐reported sensitivity was not used |