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

Sakai 2009.

Methods RCT, parallel‐arm
Teeth randomly assigned. Conducted in Brazil. Operators and setting not mentioned
Participants 30 children, 30 teeth, mean age 6.8 years, age range 5 to 9 years
Interventions Group 1:Pulpotomy (Portland cement); n = 15 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with excavator

  • For haemostasis, saline solution

  • Irrigation with saline

  • PC applied after pulpotomy, followed by IRM before being restored with glass‐ionomer cement


Group 2:Pulpotomy (MTA); n = 15 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with excavator

  • For haemostasis, saline solution

  • Irrigation with saline

  • Grey MTA applied after pulpotomy, followed by IRM before being restored with glass‐ionomer cement

Outcomes Clinical success (no spontaneous pain, no mobility, no swelling, no fistula or no smell), radiographic success (no internal root resorption and no furcation radiolucency, dentine bridge formation), swelling, pathological mobility, sinus tract, inflammation in the adjacent tissues, furcal radiolucency, internal resorption, pulp canal obliteration, dentine bridge formation: evaluation at 6, 12, 18 and 24 months (at tooth level)
Notes Reasons of dropouts:
Group 1: 3 (of 24‐month follow‐up) + 3 (after 24 months) exfoliations
Group 2: 1 (of 18‐month follow‐up) + 1 (of  24‐month follow‐up) + 3 (after 24 months) exfoliations
Source of funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The primary mandibular molars were randomly assigned to MTA or PC groups by the toss of a coin"
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: "Clinical examination… which was performed by two blinded and previously calibrated investigators"
Blinding of radiological outcomes assessment Low risk Quote: "Periapical radiographic examination… which was performed by two blinded and previously calibrated investigators"
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