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

Fuks 1997.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the paediatric dentistry undergraduate student's clinic of the Hebrew University‐Hadassah School of Dental Medicine, Israel Operators were the Israeli authors of this study
Participants 72 children, 96 teeth, mean age 7.5 years, age range 4.5 to 10 years
Interventions Group 1:Pulpotomy (formocresol); n = 38 (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

  • 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 = 58 (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

  • No irrigation

  • 15.5% FS solution applied after pulpotomy for 10 or 15 seconds. The FS was then flushed from the pulp chamber with a copious amount of water, followed by ZOE and IRM before being restored with stainless‐steel crowns

Outcomes Radiographic success (internal root resorption, furcation radiolucency or periapical bone destruction), furcal radiolucency, periapical radiolucency, internal root resorption, pulp canal obliteration, faster root resorption compared with contralateral, slower root resorption compared with contralateral, similar root resorption compared with contralateral: evaluation at 20.5: (6 to 11), (12 to 23) and (24 to 35) months (at tooth level)
Signs of failure (internal root resorption, furcation radiolucency, periapical bone destruction, pain, swelling, or sinus tract): evaluation at 20.5 (24 to 35) months (at tooth level)
Notes Source of funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Coin toss
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 Unclear risk Insufficient information to make a clear judgement
Blinding of radiological outcomes assessment Unclear risk Insufficient information to make a clear judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Proportion of missing outcomes < 10% of children randomly assigned
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement