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

Fallahinejad Ghajari 2013.

Methods RCT, split‐mouth
Teeth randomly assigned
Setting not mentioned. Conducted in Iran. One operator (no detail)
Participants 21 children, 42 teeth, mean age 6.9 ± 0.7, age range 5 to 8 years
Interventions Group 1: Direct pulp capping (MTA); n = 21 (1 visit)
  • cotton rolls and suction

  • Caries removal prior to pulpal access

  • high speed and carbide round bur

  • For haemostasis, dry cotton pellet

  • Irrigation with saline

  • ProRoot MTA before being restored with amalgam


Group 2: Direct pulp capping (CEM); n = 21 (1 visit)
  • cotton rolls and suction

  • Caries removal prior to pulpal access

  • high speed and carbide round bur

  • For haemostasis, dry cotton pellet

  • Irrigation with saline

  • CEM before being restored with amalgam

Outcomes Clinical failure (pain, swelling, tenderness to pressure, sinus tract, swelling and tenderness to percussion), radiological failure (internal and/or external root resorption, interradicular radiolucencies, and periapical lesions): evaluation at 6 and 20 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 Low risk The single operator and children were blind to biomaterial/treatment
Blinding of clinical outcomes assessment Low risk Quote: "Treatment outcomes ...were evaluated at 20 months by a calibrated dentist, radiologist and a statistician who were also blind to the type of used biomaterial"
Blinding of radiological outcomes assessment Low risk Quote: "Treatment outcomes ...were evaluated at 20 months by a calibrated dentist, radiologist and a statistician who were also blind to the type of used biomaterial"
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