Aeinehchi 2007.
Methods | RCT, parallel‐arm Children randomly assigned Conducted in the dental clinic of Azad University, Tehran, Iran. Operators were a dentist under the supervision of an endodontist |
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Participants | 126 children, 126 teeth, mean age 6.5 years, standard deviation age 1.16 years, age range 5 to 9 years | |
Interventions |
Group 1: Pulpotomy (formocresol); n = 75 (1 visit) Rubber dam Caries removal prior to pulpal access: not mentioned Pulp access with high‐speed burr Pulpotomy amputation with excavator For haemostasis, moistened cotton pellet with saline Irrigation with saline Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by zonalin dressings before being restored with amalgam or glass‐ionomer cement Group 2: Pulpotomy (MTA); n = 51 (1 visit) Rubber dam Caries removal prior to pulpal access: not mentioned Pulp access with high‐speed burr Pulpotomy amputation with excavator For haemostasis, moistened cotton pellet with saline Irrigation with saline MTA applied after pulpotomy, followed by amalgam |
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Outcomes | Clinical failure (spontaneous pain, swelling, pain on palpation or percussion and sinus tract formation, periodontal ligament widening, furcal radiolucency or apical radiolucency), pathological root resorption: evaluation at 3 and 6 months (at tooth level) Radiological failure (pathological root resorption, periodontal ligament widening and apical, lateral or furcal radiolucency): evaluation at 3 months (at tooth level) |
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Notes | Reasons for dropouts: quote: "18 in the FC group and 8 in the MTA group did not attend the 3‐month follow‐up" Comment: 55 participants excluded: not meeting inclusion (39 children), refused to participate (12 children), other reasons (4 children) Source of funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number producing system |
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 | Unclear risk | Insufficient information to make a clear judgement |
Blinding of radiological outcomes assessment | Unclear risk | Insufficient information to make a clear judgement |
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 |