Akpata 2001.
| 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 to 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 | Quote: "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 |