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. 2018 May 31;2018(5):CD003220. doi: 10.1002/14651858.CD003220.pub3

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
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)
  • Rubber dam or cotton rolls

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with slow speed bur and excavator

  • For haemostasis, cotton pellet

  • No irrigation

  • Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by IRM before being restored with stainless‐steel crown


Group 2:Pulpotomy (MTA); n = 119 (1 visit)
  • Rubber dam or cotton rolls

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with slow speed bur and excavator

  • For haemostasis, cotton pellet

  • No irrigation

  • Grey MTA (MTA 3:1 powder/saline ratio) applied after pulpotomy, followed by IRM before being restored with stainless‐steel crown

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"
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