Zealand 2010.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in the Children's Clinic of the University of Michigan School of Dentistry, USA. Operator not mentioned |
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Participants | 152 children, 252 teeth, mean age 5.5 years, standard deviation age 1.5 years, age range 2.5 to 10 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 133 (1 visit)
Group 2:Pulpotomy (MTA); n = 119 (1 visit)
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Outcomes | Clinical success (not clearly defined), radiographic failure (internal root resorption, external root resorption, internal root resorption with perforated form, periradicular lesion), score 2‐1 (clinically), score 2‐2 (clinically), score 2‐3 (clinically), score 2‐4 (clinically), internal resorption, internal resorption with perforated form, external resorption, periodontal ligament widening, pulp canal obliteration, dentine bridge formation, score 7‐1 (rx), score 7‐2 (rx), score 7‐3 (rx), score 7‐4 (rx): evaluation at 6 months (at tooth level) | |
Notes | 203/252 teeth were available for the 6‐month evaluation resulting in 19% lost at follow‐up Source of funding: "This study was supported by Michigan Institute for Clinical & Health Research and Delta Dental Foundation of Michigan. The authors declare no conflict of interest" |
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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 clear judgement |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization of the medicament used was done by an envelope draw" |
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: "The blinded clinical examination was performed by 1 to 19 operators who were calibrated to the clinical scoring criteria" |
Blinding of radiological outcomes assessment | Low risk | Quote: "All radiographs were viewed by 4 blinded, calibrated evaluators" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% children randomly assigned |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |