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

Malekafzali 2011.

Methods RCT, split‐mouth
Teeth randomly assigned
Conducted in the Paediatric Dental Clinic of Shahid Beheshti dental School, Tehran, Iran. Operators not mentioned
Participants 40 children, 80 teeth, mean age 6 years, standard deviation age 0.8 years, age range 4 to 8 years
Interventions Group 1:Pulpotomy (MTA); n = 40 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with slow‐speed bur

  • For haemostasis, moistened cotton pellet with saline

  • Irrigation with saline

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


Group 2:Pulpotomy (calcium enriched mixture); n = 40 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with slow‐speed bur

  • For haemostasis, moistened cotton pellet with saline

  • Irrigation with saline

  • CEM applied after pulpotomy, followed by IRM before being restored with amalgam or stainless‐steel crowns

Outcomes Clinical failure (swelling/abscess, sinus tract, spontaneous pain, pathological mobility, or a combination), radiological failure (furcation radiolucency, periapical bone destruction, internal root resorption and pathological external root resorption), external root resorption: evaluation at 6, 12 and 24 months (at tooth level)
Notes Source of funding: "This trial was supported by Iran National Science Foundation and Iranian Center for Endodontic Research, Shahid Beheshti Medical University, Tehran, Iran"
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) 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: "The children were examined clinically by a blinded paediatric dentist"
Blinding of radiological outcomes assessment Low risk Quote: "Radiographic evaluations were performed by a blinded oral radiologist and paedodontist"
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