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

Subramaniam 2011.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the Department of Pedodontics and Preventive Dentistry, The Oxford Dental College, Hospital and Research Centre, Bangalore, India. Operators not mentioned
Participants Number of enrolled children not mentioned, 45 teeth, age range 5 to 9 years
Interventions Group 1: Pulpectomy (calcium hydroxide + iodoform); n = 15 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with excavator

  • No haemostasis

  • Irrigation with saline and 1% sodium hypochlorite

  • Instrumentation with smooth broaches or H files

  • Metapex (CH/iodoform) applied after pulpectomy, followed by ZOE and Miracle mix, before being restored with stainless‐steel crown 1 week later


Group 2: Pulpectomy (calcium hydroxide + ZOE + iodoform); n = 15 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with excavator

  • No haemostasis

  • Irrigation with saline and 1% sodium hypochlorite

  • Instrumentation with smooth broaches or H files

  • Endoflas (CH + ZOE + iodoform) applied after pulpectomy, followed by ZOE and Miracle mix, before being restored with stainless‐steel crown 1 week later


Group 3: Pulpectomy (ZOE); n = 15 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • Pulpotomy amputation with excavator

  • No haemostasis

  • Irrigation with saline and 1% sodium hypochlorite

  • Instrumentation with smooth broaches or H files

  • ZOE applied after pulpectomy, followed by ZOE and Miracle mix, before being restored with stainless‐steel crown 1 week later

Outcomes Clinical success (no gingival swelling/inflammation/redness, no sinus opening in the oral mucosa or purulent exudate expressed from the gingival margin, no abnormal mobility other than mobility due to normal exfoliation, absence of pain on percussion/tenderness), radiographic success (no evidence of extensive pathological root resorption, reduction or no change in preoperative pathological inter‐radicular or periapical radiolucency (or both), no evidence of development of new postoperative pathological radiolucency involving the succedaneous tooth germ), pain symptoms, tenderness to percussion, swelling, pathological mobility, pathological root resorption, damage in succedaneous follicle: evaluation at 3, 6, 12 and 18 months (at tooth level)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to make a clear judgement
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 Unclear risk Insufficient information to make a clear judgement
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