Agamy 2004.
| Methods | RCT, split‐mouth Teeth randomly assigned Conducted in the Paediatric Dentistry Department, Alexandria University, Alexandria, Egypt. Operators not mentioned |
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| Participants | 24 children, 72 teeth, mean age 6.1 years, age range 4‐8 years | |
| Interventions |
Group 1: Pulpotomy (grey MTA); n = 24 (1 visit) Rubber dam Caries removal prior to pulpal access not mentioned Pulp access with high‐speed bur Pulpotomy amputation with excavator For haemostasis, moistened cotton pellet with water No irrigation Grey MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crowns Group 2: Pulpotomy (white MTA); n = 24 (1 visit) Rubber dam Caries removal prior to pulpal access not mentioned Pulp access with high‐speed bur Pulpotomy amputation with excavator For haemostasis, moistened cotton pellet with water No irrigation White MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crowns Group 3: Pulpotomy (formocresol); n = 24 (1 visit) Rubber dam Caries removal prior to pulpal access not mentioned Pulp access with high‐speed bur Pulpotomy amputation with excavator For haemostasis, moistened cotton pellet with water No irrigation Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE and IRM dressings before being restored with stainless‐steel crowns |
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| Outcomes | Clinical success (no pain symptoms, or no tenderness to percussion, or no swelling, or no fistulation, or no pathological mobility), radiographic success (no radicular radiolucency, or internal or external resorption, or periodontal ligament space widening), radicular radiolucency, pulp canal obliteration: evaluation at 1, 3, 6 and 12 months (at tooth level) | |
| Notes | Reasons of dropouts: quote: "Four children with 12 pulpotimized molars, failed to return for evaluations and were excluded from the study" Comment: 17% of participants (8% of teeth) dropped out of the study. The reasons for failure to return were not reported Source of funding: quote "This study was supported by the Zawawi Pediatric Dentistry Fund of the Indiana University Foundation. [...] The authors also wish to thank Dentsply Tulsa Dental for donating the MTA materials used in this study" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to make a judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to make a clear judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to make a clear judgement |
| Blinding of clinical outcomes assessment | Low risk | Quote: "Two examiners, who were blinded to the treatment type, evaluated the teeth clinically" |
| Blinding of radiological outcomes assessment | Low risk | Quote: "Two examiners, who were blinded to the treatment type, evaluated the teeth [...] and radiographically" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% of children randomly assigned |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |