Fallahinejad Ghajari 2013.
Methods | RCT, split‐mouth Teeth randomly assigned Setting not mentioned. Conducted in Iran. One operator (no detail) |
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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)
Group 2: Direct pulp capping (CEM); n = 21 (1 visit)
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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 |