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

Garrocho‐Rangel 2009.

Methods RCT, split‐mouth
Teeth randomly assigned
Pediatric Dentistry Postgraduate Program, Faculty of Dentistry of San Luis Potosi University, Mexico. A single operator performed all procedures
Participants 45 children, 90 teeth, median age (± standard deviation) boys: 6.4 ± 1.16 years, girls: 5.7 ± 1.01 years
Interventions Group 1:Direct pulp capping (EMD); n = 45 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • No pulpotomy amputation

  • For haemostasis, no detail, "during 2 or 3 minutes"

  • Alternating irrigations of sterile saline and chlorhexidine solution and dried gently with sterile cotton pellet

  • Direct pulp capping. EMD was placed, cavity was sealed with dentine adhesive, before being restored with glass‐ionomer cement and stainless‐steel crown


Group 2:Direct pulp capping (calcium hydroxide); n = 45 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • No pulpotomy amputation

  • For haemostasis, no detail, "during 2 or 3 minutes"

  • Alternating irrigations of sterile saline and chlorhexidine solution and dried gently with sterile cotton pellet

  • Direct pulp capping. CH was placed, cavity was sealed with dentine adhesive, before being restored with glass‐ionomer cement and stainless‐steel crown

Outcomes Signs of failure (internal dentin resorption, spontaneous pain, gingival abscess (sinus tract), external root resorption or pathological mobility), internal dentin resorption, spontaneous pain, abscess, pathological root resorption, swelling or pathological mobility; evaluation at 1, 6 and 12 months (at tooth level)
Notes Source of funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random using number sequences generated by R 2.4.0 software
Allocation concealment (selection bias) Low risk Quote: "The operator was blind to the random number schemes until just before placing the materials"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The participants…were blind regarding capping material group assignation"
Blinding of clinical outcomes assessment Low risk Quote: "Assessing observer and analyst were blind regarding capping material group assignation"
Blinding of radiological outcomes assessment Low risk Quote: "Assessing observer and analyst were blind regarding capping material group assignation"
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