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

Tuna 2008.

Methods RCT, split‐mouth
Teeth randomly assigned. Conducted in Turkey
Setting and operators not mentioned
Participants 25 children, 50 teeth, age range 5 to 8 years
Interventions Group 1:Direct pulp capping (MTA + ZOE); n = 25 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • No pulpotomy amputation

  • For haemostasis, moistened cotton pellet

  • Irrigation with saline

  • MTA (3:1 powder:saline ratio) applied as a direct pulp cap for an exposure < 1 mm pulpotomy, followed by ZOE before being restored with amalgam


Group 2: Direct pulp capping (CH + ZOE); n = 25 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access not mentioned

  • No pulpotomy amputation

  • For haemostasis, moistened cotton pellet

  • Irrigation with saline

  • CH was applied as a direct pulp cap for an exposure < 1 mm pulpotomy, followed by ZOE before being restored with amalgam

Outcomes Clinical success (no spontaneous pain, no tenderness of percussion, no swelling, no fistulation or no pathological mobility), radiographic success (no furcation radiolucency, no periodontal ligament space widening or no internal or external root resorption), thermal sensitivity: evaluation at 3, 6, 12, 18 and 24 months (at tooth level)
Notes Reasons of dropouts: 1 child did not return for evaluation after 1 month, 1 after 9 months and 1 after 12 months because of the loss of restoration that had been placed on the pulp capping material, 1 tooth was excluded from the clinical study after 9 months and 1 tooth after 18 months, both from the CH group
Lost to follow‐up: Group 1: failure to attend, n = 3; Group 2: failure to attend, n = 3; loss of restoration, n = 2
Analysed: Group 1: n = 22; Group 2: n = 20. No exclusions
Source of funding: quote: "This study was supported financially by the Scientific Research Foundation of Gazi University, Ankara, Turkey (grant no. 03/2003‐15)"
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: "...two investigators, who attended a calibration session before the follow‐up examinations, blindly evaluated the teeth clinically"
Blinding of radiological outcomes assessment Low risk Quote: "...two investigators, who attended a calibration session before the follow‐up examinations, blindly evaluated the teeth radiographically"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Proportion of missing outcomes > 10% children randomly assigned
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement