Skip to main content
. 2018 May 31;2018(5):CD003220. doi: 10.1002/14651858.CD003220.pub3

Aminabadi 2016.

Methods RCT, parallel‐arm
Teeth randomly assigned
Conducted in the Department of Pediatric Dentistry, Tabriz University of Medical Science, Iran. Operator was an expert paediatric dentist.
Participants 83 children, 160 teeth, mean age 5.14 years, age range 3 to 6 years
Interventions Group 1:direct pulp capping (3 Mix); n = 40 (1 visit)
  • Rubber dam

  • Chlorhexidine

  • Caries removal prior to pulpal access

  • Pulp access with slow‐speed bur

  • Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

  • For haemostasis, moistened cotton pellet

  • 3Mix mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5 to 2 mm and extending 2 mm beyond the margins of the exposure site

  • dry cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.


Group 2:direct pulp capping (3 Mixtatin); n = 40 (1 visit)
  • Rubber dam

  • Chlorhexidine

  • Caries removal prior to pulpal access

  • Pulp access with slow‐speed bur

  • Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

  • For haemostasis, moistened cotton pellet

  • 3Mixtatin mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5–2 mm and extending 2 mm beyond the margins of the exposure site

  • dry cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.


Group 3:direct pulp capping (simvastatin); n = 40 (1 visit)
  • Rubber dam

  • chlorhexidine

  • Caries removal prior to pulpal access

  • Pulp access with slow‐speed bur

  • Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

  • For haemostasis, moistened cotton pellet

  • Simvastatin mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5–2 mm and extending 2 mm beyond the margins of the exposure site

  • dry cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.


Group 4:direct pulp capping (White MTA); n = 40 (1 visit)
  • Rubber dam

  • chlorhexidine

  • Caries removal prior to pulpal access

  • Pulp access with slow‐speed bur

  • Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

  • For haemostasis, moistened cotton pellet

  • MTA mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5–2 mm and extending 2 mm beyond the margins of the exposure site

  • wet cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.

Outcomes Failure of treatment: pain, tenderness to palpation and percussion, sinus tract, and swelling; presence of internal or external root resorption, inter‐radicular radiolucency, and periapical lesion: evaluation at 12 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Using a computer random number generator
Allocation concealment (selection bias) Unclear risk Insufficient information to make a clear judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "The operator was not blinded to the treatment because of different manipulation techniques implemented for the study groups"
Blinding of clinical outcomes assessment Low risk Quote: "clinical and radiographic examinations were conducted at each appointment by two experienced paediatric dentists that were blinded to the techniques applied to each group"
Blinding of radiological outcomes assessment Low risk Quote: "clinical and radiographic examinations were conducted at each appointment by two experienced paediatric dentists that were blinded to the techniques applied to each group"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups
Selective reporting (reporting bias) Unclear risk Insufficient information to make a clear judgement