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

Vargas 2006.

Methods RCT, split‐mouth
Teeth randomly assigned
Conducted in the Department of Pediatric Dentistry, The University of Iowa, Iowa City, Iowa, USA. Operator was the principal investigator
Participants 23 children, 60 teeth, mean age 5 years, age range 4 to 9 years
Interventions Group 1:Pulpotomy (ferric sulphate); n = 28 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with slow‐speed bur

  • For haemostasis, dry cotton pellet

  • Solutions rinsed with water

  • FS applied after pulpotomy for 15 seconds, followed by IRM before being restored with stainless‐steel crown


Group 2:Pulpotomy (sodium hypochlorite); n = 32 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with slow‐speed bur

  • For haemostasis, dry cotton pellet

  • Solutions rinsed with water

  • Cotton wool pellet soaked with 5% sodium hypochlorite placed on pulp stumps for 30 seconds after pulpotomy, followed by IRM before being restored with stainless‐steel crown

Outcomes Clinical failure (mobility, swelling, fistula, history of spontaneous pain), radiographic success (no external root resorption, no internal root resorption, no inter‐radicular bone destruction), overall success ((% clinical success + % radiographic success)/2), pain palpation, swelling, fistula, pathological mobility, redness, bleeding, furcation involvement, internal resorption: evaluation at 6 and 12 months (at tooth level)
Notes No reason of dropouts, except "2 teeth exfoliated and were eliminated from further follow‐up"
Source of funding: quote: "This research was supported by the Obermann Center for Advanced Studies Spelman Rockefeller Grant from The University of Iowa, Iowa City, Iowa"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random table
Allocation concealment (selection bias) Low risk Quote: "subject assignment was made at the consent appointment, but allocation of the tooth according to the allocation sequence was made the day of the treatment visit"; "this allocation followed the current guidelines for randomised clinical trials put forth by CONSORT [Consolidated Standards of Reporting Trials]"
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 Quote: "...the clinical examination was performed by the principal investigator without immediate knowledge of which treatment has been rendered on which tooth"
Blinding of radiological outcomes assessment Low risk Quote: "...all radiographs were read… by 2 co‐investigators who were blinded to the technique used"
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