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

Huth 2005.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the Pedodontic Section, Department of Restorative Dentistry and Periodontology, Ludwig‐Maximilians‐University, Munich, Germany. Operators were 2 paedodontists
Participants 107 children, 191 teeth, mean age 4.8 years, standard deviation age 1.6 years, age range 2 to 8 years
Interventions Group 1:Pulpotomy (formocresol); n = 50 (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, moistened cotton pellet with saline

  • No irrigation

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


Group 2:Pulpotomy (Er:YAG); n = 47 (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, moistened cotton pellet with saline

  • No irrigation

  • Er:YAG laser: 2 Hz and 180 mJ/pulse without water cooling. Mean (± standard deviation) number of laser pulses per tooth: 31.5 ± 5.9 equally distributed to each pulp. Followed by IRM before being restored with glass‐ionomer cement and composite or stainless‐steel crowns


Group 3:Pulpotomy (calcium hydroxide); n = 44 (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, moistened cotton pellet with saline

  • No irrigation

  • CH placed after pulpotomy for 15 seconds, followed by IRM before being restored with glass‐ionomer cement and composite or stainless‐steel crowns


Group 4:Pulpotomy (ferric sulphate); n = 50 (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, moistened cotton pellet with saline

  • No irrigation

  • 15.5% FS solution after pulpotomy, followed by IRM before being restored with glass‐ionomer cement and composite or stainless‐steel crowns

Outcomes Clinical failure (spontaneous pain, tenderness to percussion, fistula, soft tissue swelling, and pathological tooth mobility), spontaneous pain, tenderness to percussion, swelling, fistula, pathological mobility: evaluation at 6, 12, 18 and 24 months
Radiological failure (periapical or furcal radiolucency, pathological external or distinct internal root resorption, or widened periodontal ligament space), signs of failure (spontaneous pain, tenderness to percussion, fistula, soft tissue swelling, pathological tooth mobility, periapical or furcal radiolucency, pathological external or distinct internal root resorption, or widened periodontal ligament space), furcal radiolucency, periapical radiolucency, internal root resorption, external root resorption, periodontal ligament widening: evaluation at 12 and 24 months (at tooth level)
Notes Reasons of dropouts: "103 patients (191 teeth followed up): 3 teeth from the laser group and 6 from the calcium hydroxide group were excluded from follow‐up and statistical analysis, due to uncontrollable bleeding during radiation or placement of calcium hydroxide, since a hyperemic, inflamed radicular pulp is considered a contraindication for vital pulpotomy"; "12 teeth had exfoliated physiologically"
Comment: quotes: "4 patients moved away"
Source of funding: quote: "The study was completely financed by Departmental funding". (Department of Restorative Dentistry & Periodontology, Dental School, Ludwig‐Maximilians‐University, Munich)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...by an assistant casting a concealed lot from a box containing 4 x 50 lots (block randomization)"
Allocation concealment (selection bias) Low risk Quote: "...all other contributors for the study were blinded to generation and implementation of the treatment assignment"
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 re‐evaluations …were performed independently by two experienced dentists (not the operators) blinded to the technique"; "the outcome assessment and data analysis were blinded, since the techniques were indistinguishable and coded"
Blinding of radiological outcomes assessment Low risk Quote: "radiographic examinations were performed independently by two experienced dentists (not the operators) blinded to the technique"; "the outcome assessment and data analysis were blinded, since the techniques were indistinguishable and coded"
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