Mello 2018.
Study characteristics | ||
Methods | RCT, parallel groups Duration of study: 4–6 months (mean 5 months) Setting: secondary care (University), Brazil |
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Participants | 44 children, 62 primary teeth Age: 5–9 years Inclusion criteria: deep carious primary molars (> 2/3 into dentine); without sensitivity or spontaneous pain (or both) or pulp exposure, tooth mobility, fistula or abscess, pulp or root pathologies observed on radiograph; or root resorption of > 2/3 on radiograph; and tooth with restorative possibility Exclusion criteria: children with systemic diseases, allergy to latex or local anaesthetic |
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Interventions | 2 treatment arms Group 1 (24 teeth): SE: infected dentin was removed, while the affected dentin was maintained on the pulpal wall. Group 2 (38 teeth): non‐selective caries removal: both infected and affected dentin removed. |
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Outcomes |
Primary outcome Signs or symptoms of pulpal disease: pain, clinical or radiological loss of vitality, mobility, root resorption, etc. Clinically/radiographically success/failure after 6 months Secondary outcome Pulp exposure during excavation |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Authors did not report method of random allocation to treatment groups. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Single operator performed both treatments. Blinding of dentist not possible due to differences in techniques. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding not possible for the outcome of pulp exposure as the operator assessed it during treatment. Clinical and radiological examination blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All teeth included in analysis. |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported. |
Other bias | Low risk | No other biases detected. |