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

El Meligy 2016.

Methods RCT, split‐mouth
Teeth randomly assigned
Conducted at the Pediatric Dental Clinics, Faculty of Dentistry, King Abdulaziz University (KAU), Jeddah. Operators not mentioned
Participants 37 children, 56 pairs, 112 teeth; mean age 6 ± 0.75 years, age range 4 to 8 years
Interventions Group 1:Pulpotomy (formocresol); n = 56 teeth (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator

  • Haemostasis with sterile wet cotton pellet

  • Irrigation with normal saline

  • Cotton wool pellet soaked with 1:5 diluted FC placed on pulp stumps for 5 minutes after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crown


Group 2:Pulpotomy (Biodentine); n = 56 teeth (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator

  • Haemostasis with sterile wet cotton pellet

  • Irrigation with normal saline

  • Biodentine before being restored with stainless‐steel crown

Outcomes Clinical success (absence of sensitivity, pain, or swelling, no tenderness to percussion, no abscess or fistulation, no tooth mobility), radiographic success (absence of furcation and periapical radiolucency, absence of internal or external root resorption), presence of a normal periodontal ligament space, presence of pulp canal obliteration: evaluation at 3 and 6 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to make a clear judgement of Yes or No
Allocation concealment (selection bias) Unclear risk Insufficient information to make a clear judgement of Yes or No
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to make a clear judgement of Yes or No
Blinding of clinical outcomes assessment Low risk Quote: "Independently, two examiners who were blinded to treatment type evaluated the teeth clinically and radiographically."
Blinding of radiological outcomes assessment Low risk Quote: "Independently, two examiners who were blinded to treatment type evaluated the teeth clinically and radiographically."
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