| Methods | Trial design: Parallel‐group Location: Göttingen, Germany Funding source: University of Göttingen |
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| Participants | Inclusion criteria: Caries media or caries profunda (according to bitewing radiographs), insufficient fillings, positive reaction to a vitality test (cold test), no signs of pulp inflammation, no spontaneous pain attacks before treatment, only premolars and molars, only 1 filling per tooth, and a minimum extension of the cavity of 1 mm in width Age: 18 years or older Exclusion criteria: Patients under 18 years, pregnancy, breastfeeding, immunosuppressed or addicted patients Number of randomised individuals: 123 Number of randomised teeth: 123 Number of individuals evaluated: 123 Dropouts: None |
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| Interventions | Calcium hydroxide (CaOH) liner under 2 brands RBC restoration compared to no liner under 2 brands RBC restoration | |
| Outcomes | Postoperative hypersensitivity as measured by patient reporting | |
| Notes | Maximum age of participants not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The decision to use a calcium hydroxide liner or not was made by tossing a coin" |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded. "The patients were not told to which cavity‐depth group their tooth was allocated and if calcium hydroxide was used or not." Operators were not blinded but risk of bias still low even though operator not blinded as it is not possible to blind the operator |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| 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 |
CRM: cold response measurement; RBC: resin‐based composite; RMGI: resin‐modified glass ionomer; TMD: temporomandibular disorder; VAS: visual analog scale.