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

Ibricevic 2000.

Methods RCT, parallel‐arm
Children randomly assigned
Setting not mentioned. Conducted in Kuwait. Operator was 1 senior paedodontist
Participants 70 children, 164 teeth, mean age 4.3 years, age range 3 to 6 years
Interventions Group 1:Pulpotomy (formocresol); n = 80 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with high‐speed bur

  • For haemostasis, dry cotton pellet

  • Irrigation with saline

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


Group 2:Pulpotomy (ferric sulphate); n = 84 (1 or 2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with high‐speed bur

  • For haemostasis, dry cotton pellet

  • Irrigation with saline

  • 15.5% FS solution after pulpotomy for 15 seconds, followed by ZOE. For very uncooperative children, over the ZOE paste, IRM was placed for 5 days and then restoration with amalgam or stainless‐steel crown

Outcomes Clinical success (absence of any fistula, abscess, swelling, spontaneous pain or pathological mobility), radiological failure (normal periodontal ligament space, no pathological internal or external root resorption and no intraradicular or periapical radiolucency), internal root resorption, periapical bone destruction, inter‐radicular bone destruction, succedaneous tooth structural anomaly: evaluation at 3 to 20 and 46 to 48 months (at tooth level)
Signs of failure (internal root resorption, furcation radiolucency, periapical bone destruction, or a combination): evaluation at 46 to 48 months (at tooth level)
Notes The first 70 teeth were all treated within 1 month. The pulpotomy therapy of a further 124 primary molars was performed on the same children, during the following 6 months. On the final recall after 42 to 48 months, only 60 children appeared within the 4 months' recall period
Clinical follow‐up: every 3 months
Radiographic follow‐up: 6, 20 and 42 to 48 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Alternate allocation
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 High risk Quote: "The clinical follow‐up by the same examiner who had performed all pulpotomies and was aware to which treatment groups the subjects belonged"
Blinding of radiological outcomes assessment Low risk Quote: "Both authors, blindly, evaluated radiographs"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement