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

Fei 1991.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the Pediatric Dental Clinic at the University of Southern California School of Dentistry. Operators not mentioned
Participants 62 children, 83 teeth, mean age 6.7 years, age range 3.2 to 10.1 years
Interventions Group 1:Pulpotomy (formocresol); n = not stated (27 teeth analysed) (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator or slow‐speed bur

  • For haemostasis, dry cotton pellet

  • No irrigation

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


Group 2:Pulpotomy (ferric sulphate); n = not stated (29 teeth analysed) (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator or slow‐speed bur

  • For haemostasis, dry cotton pellet

  • No irrigation

  • 15.5% FS solution applied after pulpotomy, followed by ZOE and IRM before being restored with stainless‐steel crowns

Outcomes Clinical success (no symptoms of pain, tenderness to percussion, swelling, fistulation or pathological tooth mobility), radiographic success (normal periodontal ligament, absence of pathological internal root resorption, external root resorption, no intraradicular or no periapical radiolucency), signs of failure (symptoms of pain, tenderness to percussion, swelling, fistulation, pathological tooth mobility, abnormal periodontal ligament, pathological internal root resorption, external root resorption, intraradicular or periapical radiolucency), internal root resorption, pulp canal obliteration: evaluation at 3, 6 and 12 months (at tooth level)
Notes 56 teeth from 48 children were available for evaluation after 12 months (Group 1: 27; Group 2: 29)
Source of funding: not reported, although FS material was provided by a manufacturer
 Quote: "The ferric sulphate tested in this study was provided by the Ultradent Company"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table
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 evaluations of the teeth were conducted by two independent examiners who had no knowledge of the group to which the particular tooth was assigned"
Blinding of radiological outcomes assessment Low risk Quote: "Radiological evaluations of the teeth were conducted by two independent examiners who had no knowledge of the group to which the particular tooth was assigned"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Number of randomised teeth unknown
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement