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

Aminabadi 2010.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the Department of Pediatric Dentistry at Tabriz University of Medical Sciences School of Dentistry, Iran. Operators not mentioned
Participants 84 children, 120 teeth, mean age 4.4 years, age range 4 to 5 years
Interventions Group 1:Direct pulp capping (formocresol + ZOE); n = 60 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with slow‐speed bur

  • No pulpotomy amputation

  • Haemostasis not mentioned

  • Irrigation with saline

  • Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes for direct pulp capping, followed by ZOE dressings before being restored with stainless‐steel crowns


Group 2:Direct pulp capping (calcium hydroxide + ZOE); n = 60 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with slow‐speed bur

  • No pulpotomy amputation

  • Haemostasis not mentioned

  • Irrigation with saline

  • CH applied for direct pulp capping, followed by ZOE dressings before being restored with stainless‐steel crowns

Outcomes Clinical success (spontaneous pain, or pain initiated by stimuli; signs of a defective restoration or recurrent caries; signs of mobility, sinus formation, tenderness to percussion, or soft tissue swelling; and signs of exfoliation, mobility or signs/symptoms of the successor tooth erupting), radiological success (defective restoration or recurrent caries; periradicular pathology such as periapical or furcal radiolucency; and pathological internal resorption, replacement resorption, intracanal calcifications, or physiological root resorption): evaluation at 24 months (at tooth level)
Spontaneous pain, tenderness to percussion, fistula or parulis, periapical radiolucency or furcal radiolucency, internal resorption or external resorption: evaluation at 6, 12, 18 and 24 months
Notes  
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 Low risk Quote: "objectivity was maximized by not having direct access during [...] clinical evaluation to records detailing which pulp therapy agent was used"
Blinding of radiological outcomes assessment Low risk Quote: "objectivity was maximized by not having direct access during [...] radiological evaluation to records detailing which pulp therapy agent was used"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement