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

Grewal 2016.

Methods RCT, split‐mouth
Children randomly assigned
Conducted at the Outpatient Department of Paediatric Dentistry, Punjab Government Dental College and Hospital, Amritsar, Punjab, India. Operators not mentioned.
Participants 20 children, 40 teeth, mean age 7.35 years, age range 5 to 10 years
Interventions Group 1:Pulpotomy (Biodentine); n = 20 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with round burs no. ½ and ¼ or excavator

  • For haemostasis, dry sterile cotton pellet

  • Irrigation with saline

  • Before the capsule was opened, it was tapped gently on a hard surface to diffuse the powder. Five drops of liquid from the single‐dose dispenser were poured into the capsule, after which the latter was placed in a triturator for 30 s. The material was then transferred with the aid of the manufacturer supplied spatula and placed inside the cavity with the aid of an amalgam carrier or spatula. To adjust it against the walls without excessive compression a plugger or sterile cotton pellet was used. The entire cavity was filled with Ca3SiO5 till the second appointment. After 24/48h, leaving half depth of the cavity with Ca3SiO5 material without any voids or lack of marginal adaptation checked under a surgical operating microscope, the final restoration was done with nanohybrid composite resin


Group 2:Pulpotomy (CH); n = 20 (2 visits)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation with round burs no. ½ and ¼ or excavator

  • For haemostasis, dry sterile cotton pellet

  • Irrigation with saline

  • CH paste was gently applied with the help of disposable tip topped by light cured CH, and the cavity was restored with glass ionomer cement. In the recall visit after 24 to 48 h, after removing top layer of GIC up to half of cavity depth, teeth were restored with nanohybrid composite resin

Outcomes Pain, swelling: evaluation at 3, 6 and 12 months; mean dentin thickness, internal root resorption: evaluation at 6 and 12 months; colour matching, marginal discolouration, secondary caries, anatomic form, surface texture, marginal integrity, pulp sensitivity: evaluation at 12 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerised random‐number
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: "Blinded clinical and radiographic outcomes were observed"
Blinding of radiological outcomes assessment Low risk Quote: "Blinded clinical and radiographic outcomes were observed"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Proportion of missing outcomes > 10% of children randomly assigned
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement