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

Pramila 2016.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in Saveetha Dental College and Hospital, India. Operator was an investigator
Participants 88 children, 129 teeth, age range 4 to 9 years
Interventions Group 1:Pulpectomy (RC Fill); n = 43 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access not mentioned

  • Pulp access with high speed

  • Pulpotomy amputation with excavator

  • Instrumentation with barbed broaches and H‐files

  • Irrigation with saline and finally with 2% chlorhexidine


RC Fill available in powder and liquid form, mixed to the desired consistency according to the manufacturer’s instructions. A Lentulo spiral was used to place the RC Fill, followed by glass ionomer cement, before being restored with stainless steel crown.
Group 2:Pulpectomy (Vitapex); n = 43 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access not mentioned

  • Pulp access with high speed

  • Pulpotomy amputation with excavator

  • Instrumentation with barbed broaches and H‐files

  • Irrigation with saline and finally with 2% chlorhexidine


Vitapex available in preformed syringes. The syringe was inserted into the canal near the apex. The paste was extruded into the canal, and the syringe was then slowly withdrawn as it filled the entire canal, followed by glass ionomer cement, before being restored with stainless steel crown.
Group 3:Pulpectomy (ZOE); n = 43 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access not mentioned

  • Pulp access with high speed

  • Pulpotomy amputation with excavator

  • Instrumentation with barbed broaches and H‐files

  • Irrigation with saline and finally with 2% chlorhexidine


ZOE available in powder and liquid form, mixed to the desired consistency according to the manufacturer’s instructions. An Endodontic Pressure Syringe was used to place ZOE, followed by glass ionomer cement, before being restored with stainless steel crown.
Outcomes Clinical failure (pain, tenderness to percussion, swelling/abscess, mobility and draining fistula), radiographic failure (furcation, radiolucency, periapical radiolucency, internal root resorption, external root resorption, lamina dura, deviation in the path of eruption, intraradicular resorption, resorption of extruded material), overall success: evaluation at 6, 12 and 30 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque and sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The participants and outcome assessors were blinded about the filling materials used"
Blinding of clinical outcomes assessment Low risk Quote: "The participants and outcome assessors were blinded about the filling materials used"
Blinding of radiological outcomes assessment Low risk Quote: "The participants and outcome assessors were blinded about the filling materials used"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Proportion of missing outcomes > 10% of children randomly assigned
Selective reporting (reporting bias) Low risk Protocol prospectively registered (CTRI/2011/06/001776). no discrepancies in outcomes between registered record and published RCT.