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