Malekafzali 2011.
Methods | RCT, split‐mouth Teeth randomly assigned Conducted in the Paediatric Dental Clinic of Shahid Beheshti dental School, Tehran, Iran. Operators not mentioned |
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Participants | 40 children, 80 teeth, mean age 6 years, standard deviation age 0.8 years, age range 4 to 8 years | |
Interventions |
Group 1:Pulpotomy (MTA); n = 40 (1 visit)
Group 2:Pulpotomy (calcium enriched mixture); n = 40 (1 visit)
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Outcomes | Clinical failure (swelling/abscess, sinus tract, spontaneous pain, pathological mobility, or a combination), radiological failure (furcation radiolucency, periapical bone destruction, internal root resorption and pathological external root resorption), external root resorption: evaluation at 6, 12 and 24 months (at tooth level) | |
Notes | Source of funding: "This trial was supported by Iran National Science Foundation and Iranian Center for Endodontic Research, Shahid Beheshti Medical University, Tehran, Iran" | |
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 | Unclear risk | Insufficient information to make a clear judgement |
Blinding of clinical outcomes assessment | Low risk | Quote: "The children were examined clinically by a blinded paediatric dentist" |
Blinding of radiological outcomes assessment | Low risk | Quote: "Radiographic evaluations were performed by a blinded oral radiologist and paedodontist" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% of children randomly assigned |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |