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

Zurn 2008.

Methods RCT, split‐mouth
Teeth randomly assigned
Conducted in the Department of Pediatric Dentistry, Baylor College of Dentistry Texas, Health Science Center, Dallas, Texas, USA. Operator were 2 standardised operators
Participants 23 children, 76 teeth, mean age 5.3 years, standard deviation age 1.7 years, age range 2.3 to 8.5 years
Interventions Group 1:Pulpotomy (formocresol); n = 38 (1 visit)
  • Rubber dam or cotton rolls

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator

  • For haemostasis, moistened cotton pellet with water

  • No irrigation

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


Group 2:Pulpotomy (calcium hydroxide); n = 38 (1 visit)
  • Rubber dam or cotton rolls

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator

  • For haemostasis, moistened cotton pellet with water

  • No irrigation

  • Light‐cured CH applied after pulpotomy, before being restored with glass‐ionomer cement and stainless‐steel crown

Outcomes Clinical success (not clearly defined), radiographic failure (not clearly defined), overall success (the cumulative rate of failure due to clinical abscesses or osseous radiolucencies was calculated for each treatment, as was an overall cumulative rate of success. These calculations were based on the following equation: failure percentage = 100% x (previous failures + new failures)/(previous failures + currently examined teeth)), abscess, internal resorption, internal resorption with perforated form, external resorption, periodontal ligament widening, calcific metamorphosis, bone radiolucency: evaluation at 0 to 6, 7 to 12 and 13 to 24 months (at tooth level)
Notes 3 children were lost due to failure to return for follow‐up
Analysed: 20 children, 68 teeth
Source of funding: quote: "This research project won the Ralph E. MacDonald (sic) Award at the 2006 AAPD annual session for the most outstanding research presented by a graduate student"
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 Low risk Quote: "...all postoperative radiographs were digitally scanned and evaluated by 2 standardized and calibrated examiners. To blind the examiners to the treatment regimens, the coronal portions were blackened‐out"
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

CEM: calcium‐enriched mixture; CH: calcium hydroxide; clin: clinically; EMD: enamel matrix derivative; Er‐YAG: erbium:yttrium‐aluminium garnet; FC: formocresol; FS: ferric sulphate; IRM: intermediate restorative material (reinforced zinc oxide and eugenol); MTA: mineral trioxide aggregate; n: number of teeth; PC: Portland cement; RCT: randomised controlled trial; rx: radiographically; ZOE: zinc oxide and eugenol