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 |