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

Celik 2013.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the paediatric dental clinic at the School of Dentistry, Hacettepe University, Ankara, Turkey. Operator was a paediatric dentist.
Participants 75 children, 139 teeth, 3 to 9 years
Interventions Group 1:Pulpotomy (ProRoot MTA); n = 46 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed, followed by slow‐speed bur

  • Pulpotomy amputation with high speed followed by excavator

  • Haemostasis with saline‐moistened sterile cotton pellets for two to four minutes

  • Irrigation with saline

  • White MTA mixed according to the manufacturer’s instructions to produce a homogenous paste.The material was placed in the pulp chamber with a plastic carrier. Light pressure was applied with moist cotton pellets to enhance adaptation of the material. Then followed by conventional glass ionomer cement then by amalgam (followed by fissure sealant at the margins).


Group 2:Pulpotomy (MTA Angelus); n = 45 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed, followed by slow‐speed bur

  • Pulpotomy amputation with high speed followed by excavator

  • Haemostasis with saline‐moistened sterile cotton pellets for two to four minutes

  • Irrigation with saline

  • Angelus MTA mixed according to the manufacturer’s instructions to produce a homogenous paste.The material was placed in the pulp chamber with a plastic carrier. Light pressure was applied with moist cotton pellets to enhance adaptation of the material. Then followed by conventional glass ionomer cement then by amalgam (followed by fissure sealant at the margins).


Group 3:Pulpotomy (CH); n = 48 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed, followed by slow‐speed bur

  • Pulpotomy amputation with high speed followed by excavator

  • Haemostasis with saline‐moistened sterile cotton pellets for two to four minutes

  • Irrigation with saline

  • Calcium hydroxide powder mixed with sterile water in a 3:1 ratio to produce a homogeneous paste. The material was placed in the pulp chamber as described for groups 1 and 2.

  • Then followed by conventional glass ionomer cement then by amalgam (followed by fissure sealant at the margins).

Outcomes Clinical success (absence of spontaneous pain and/ or sensitivity to palpation/percussion; absence of fistula, swelling, and/or abnormal mobility), radiological success (absence of radiolucencies at the inter‐radicular and/or periapical regions, absence of pulp canal obliteration (fully obliterated canals); and absence of internal or external (pathologic) resorption), defective restoration (clinically): evaluation at 1, 3, 6, 12, 18, 24 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) Low risk Quote: "...sequentially numbered opaque‐sealed envelopes"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "Operator blinding was not possible"
Blinding of clinical outcomes assessment Low risk Quote: "Two calibrated operators, blinded to group assignment and treatment, performed ...clinical ...recall examinations"
Blinding of radiological outcomes assessment Low risk Quote: "Two calibrated operators, blinded to group assignment and treatment, performed ...radiographic recall examinations"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Proportion of missing outcomes < 10% of children randomly assigned
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement