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

Kusum 2015.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University, UP, Lucknow. Operator not mentioned.
Participants 90 children, 90 teeth, mean age 6.8 years, age range 3 to 10 years
Interventions Group 1:Pulpotomy (MTA); n = 25 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator

  • For haemostasis, moistened cotton pellet with distilled water

  • Irrigation not mentioned

  • MTA: putty‐like consistency, condensed lightly with a moistened sterile cotton pellet to ensure a thickness of 2 to 3 mm, followed by ZOE before being restored with glass ionomer then stainless‐steel crowns (second visit)


Group 2:Pulpotomy (Biodentine); n = 25 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator

  • For haemostasis, moistened cotton pellet with distilled water

  • Irrigation not mentioned

  • Biodentine: obtained by mixing pre‐measured unit dose capsules for 30 seconds at 4200 rpm in a triturator to obtain putty‐like consistency, then carried with an amalgam carrier and condensed lightly with a metal condenser on the pulp stumps, in a thickness of 2 to 3 mm, followed by ZOE before being restored with glass ionomer then stainless‐steel crowns (second visit)


Group 3:Pulpotomy (propolis); n = 25 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with excavator

  • For haemostasis, moistened cotton pellet with distilled water

  • Irrigation not mentioned

  • 1.5 g standardised propolis extract powder at 100% was mixed with 1.75 mL polyethylene glycol to form a thick consistency on a clean dry glass slab with a metal spatula, then the paste was carried to the pulp stumps with a metal carrier and then condensed lightly to a thickness of 2 to 3 mm, followed by ZOE before being restored with glass ionomer then stainless‐steel crowns (second visit)

Outcomes Clinical and radiographic criteria for assessing teeth were explained along with a calibration process to the two observers on three initial cases. The criteria, based on Zurn and Seale has been used for scoring the clinical and radiographic findings. The scoring system was devised to represent severity of changes but not to define an individual tooth as a ‘success’ or ‘failure’, i.e. as the score gets larger, the pathologies get progressively more invasive and require more frequent follow‐up. Teeth scored as 1 or 2 were considered successful. Evaluation at 3, 6 and 9 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
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: "The teeth were evaluated clinically and radiographically by two observers independently who were blinded to the treatment type"
Blinding of radiological outcomes assessment Low risk Quote: "The teeth were evaluated clinically and radiographically by two observers independently who were blinded to the treatment type"
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